Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis (NCT NCT03002974)
NCT ID: NCT03002974
Last Updated: 2020-07-15
Results Overview
Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100). Average of the assessments performed at 24, 48 and 72 hours.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study
Results posted on
2020-07-15
Participant Flow
Participant milestones
| Measure |
Triamcinolone 40 mg
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
54
|
|
Overall Study
Intention To Treat Populatio
|
55
|
56
|
54
|
|
Overall Study
Safety Population
|
54
|
55
|
52
|
|
Overall Study
COMPLETED
|
35
|
40
|
36
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
Baseline characteristics by cohort
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
53.7 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
54.0 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
54.8 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
143 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
119 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=99 Participants
|
56 participants
n=107 Participants
|
54 participants
n=206 Participants
|
165 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the studyPatients will score their pain intensity in the joint most affected at baseline (index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100). Average of the assessments performed at 24, 48 and 72 hours.
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS
24 hours
|
-26.1 Units on a scale
Interval -32.5 to -19.6
|
-32.5 Units on a scale
Interval -38.8 to -26.1
|
-31.1 Units on a scale
Interval -37.6 to -24.6
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS
48 hours
|
-43.4 Units on a scale
Interval -50.8 to -36.0
|
-42.9 Units on a scale
Interval -50.0 to -35.9
|
-43.6 Units on a scale
Interval -51.0 to -36.3
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS
72 hours
|
-45.2 Units on a scale
Interval -52.7 to -37.7
|
-51.6 Units on a scale
Interval -58.9 to -44.3
|
-49.1 Units on a scale
Interval -56.5 to -41.6
|
SECONDARY outcome
Timeframe: At baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8 for the first gout flare treated in the studyPatients will score their pain intensity in the joint most affected at baseline (index joint) on a 5-point Likert scale (0-4 point scale: "none", "mild", "moderate", "severe", "extreme") at time points baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8.
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
12 hours
|
-0.9 Score on a scale
Standard Deviation 0.6
|
-1.1 Score on a scale
Standard Deviation 1.2
|
-0.5 Score on a scale
Standard Deviation 0.7
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
18 hours
|
-0.8 Score on a scale
Standard Deviation 0.8
|
-1.2 Score on a scale
Standard Deviation 1.0
|
-0.8 Score on a scale
Standard Deviation 0.9
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
24 hours
|
-1.0 Score on a scale
Standard Deviation 0.8
|
-0.9 Score on a scale
Standard Deviation 1.0
|
-1.1 Score on a scale
Standard Deviation 0.9
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
36 hours
|
-1.3 Score on a scale
Standard Deviation 0.8
|
-1.3 Score on a scale
Standard Deviation 1.0
|
-1.1 Score on a scale
Standard Deviation 0.7
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
48 hours
|
-1.5 Score on a scale
Standard Deviation 1.0
|
-1.4 Score on a scale
Standard Deviation 1.0
|
-1.5 Score on a scale
Standard Deviation 1.0
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
72 hours
|
-1.6 Score on a scale
Standard Deviation 1.1
|
-1.6 Score on a scale
Standard Deviation 1.0
|
-1.7 Score on a scale
Standard Deviation 0.9
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
Day 5
|
-1.8 Score on a scale
Standard Deviation 1.1
|
-1.8 Score on a scale
Standard Deviation 1.1
|
-1.8 Score on a scale
Standard Deviation 1.1
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
Day 6
|
-1.9 Score on a scale
Standard Deviation 1.1
|
-2.2 Score on a scale
Standard Deviation 1.1
|
-1.9 Score on a scale
Standard Deviation 1.0
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
Day 7
|
-2.4 Score on a scale
Standard Deviation 0.8
|
-2.2 Score on a scale
Standard Deviation 1.1
|
-1.9 Score on a scale
Standard Deviation 1.0
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
Day 8
|
-1.9 Score on a scale
Standard Deviation 0.9
|
-2.1 Score on a scale
Standard Deviation 1.1
|
-2.1 Score on a scale
Standard Deviation 1.0
|
|
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
6 hours
|
-0.6 Score on a scale
Standard Deviation 0.7
|
-0.8 Score on a scale
Standard Deviation 0.9
|
-0.4 Score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: From baseline (predose) up to Day15 of the first flare treated in the studyOnset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS)
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Median Time to Onset of Effect
|
22.3 Hours
Interval 13.9 to 24.6
|
11.8 Hours
Interval 7.7 to 24.0
|
19.8 Hours
Interval 12.1 to 30.0
|
SECONDARY outcome
Timeframe: From baseline (predose) up to Day15 of the first flare treated in the studyResponse defined as 50% change from baseline pain intensity on a visual analogue scale (VAS)
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Median Time to Response
|
47.6 Hours
Interval 40.3 to 67.7
|
43.0 Hours
Interval 18.6 to 70.4
|
46.9 Hours
Interval 24.1 to 67.4
|
SECONDARY outcome
Timeframe: From baseline (predose) up to Day15 of the first flareResolution of pain defined as \<10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Median Time to Resolution of Pain
|
167.5 Hours
Interval 120.1 to 264.2
|
131.8 Hours
Interval 70.9 to
SAS Proc Lifetest was used. Abridged explanation from the SAS documentation:
"Consider the linear transform \[..\] If the curve that represents the upper confidence limits lies above 0.75, the upper confidence limit for Q1 cannot be estimated\[..\]."
|
119.8 Hours
Interval 69.0 to 144.2
|
SECONDARY outcome
Timeframe: From Day 1 to Day 15 for the first flare treatedTime to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration
Outcome measures
| Measure |
Triamcinolone 40 mg
n=25 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=26 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=22 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Median Time to First Intake of Rescue Medication From First Investigational Drug Administration
|
NA Hours
Interval 126.5 to
Non-calculable
|
NA Hours
Interval 114.4 to
Non-calculable
|
NA Hours
Interval 220.7 to
Non-calculable
|
SECONDARY outcome
Timeframe: At 72 hours, Day 8 and Day 15 for the first flare treated in the study5-point Likert scale (0- to 4-point scale: "none", "mild", "moderate", "severe, "extreme") where higher score mean worse outcome
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Physician's Assessment of Global Response to Treatment
72 hours
|
1.54 Score on a scale
Interval 1.23 to 1.85
|
1.25 Score on a scale
Interval 0.94 to 1.55
|
1.25 Score on a scale
Interval 0.94 to 1.56
|
|
Physician's Assessment of Global Response to Treatment
Day 8
|
1.26 Score on a scale
Interval 0.93 to 1.59
|
0.90 Score on a scale
Interval 0.59 to 1.2
|
0.81 Score on a scale
Interval 0.48 to 1.14
|
|
Physician's Assessment of Global Response to Treatment
Day 15
|
1.04 Score on a scale
Interval 0.69 to 1.39
|
0.80 Score on a scale
Interval 0.47 to 1.13
|
0.78 Score on a scale
Interval 0.46 to 1.13
|
SECONDARY outcome
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study4-point Likert scale (0=no pain, 1= mild/patient states there is pain when touched, 2= moderate/patient states there is pain and Winces, 3=severe/patient states there is pain, winces and withdraws
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
72 hours : None
|
8 Participants
|
18 Participants
|
16 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
72 hours : Mild
|
22 Participants
|
28 Participants
|
25 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
72 hours : Moderate
|
17 Participants
|
4 Participants
|
9 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
72 hours : Severe
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
72 hours : Missing
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 8 : None
|
19 Participants
|
28 Participants
|
30 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 8 : Mild
|
25 Participants
|
19 Participants
|
17 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 8 : Moderate
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 8 : Severe
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 8 : Missing
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 15 : None
|
37 Participants
|
38 Participants
|
32 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 15 : Mild
|
10 Participants
|
9 Participants
|
12 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 15 : Moderate
|
1 Participants
|
5 Participants
|
5 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 15 : Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Day 15 : Missing
|
6 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins)
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Baseline : None
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Baseline : Mild
|
9 Participants
|
14 Participants
|
7 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Baseline : Moderate
|
23 Participants
|
27 Participants
|
28 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Baseline : Severe
|
23 Participants
|
15 Participants
|
18 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Baseline : Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
72 hours : None
|
14 Participants
|
27 Participants
|
17 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
72 hours : Mild
|
22 Participants
|
18 Participants
|
26 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
72 hours : Moderate
|
10 Participants
|
7 Participants
|
7 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
72 hours : Severe
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
72 hours : Missing
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 8 : None
|
25 Participants
|
37 Participants
|
38 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 8 : Mild
|
16 Participants
|
13 Participants
|
9 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 8 : Moderate
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 8 : Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 8 : Missing
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 15 : None
|
37 Participants
|
44 Participants
|
34 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 15 : Mild
|
9 Participants
|
6 Participants
|
14 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 15 : Moderate
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 15 : Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Day 15 : Missing
|
6 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the studyPhysicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Baseline : Absent
|
3 Participants
|
8 Participants
|
8 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Baseline : Present
|
51 Participants
|
48 Participants
|
45 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Baseline : Missing
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
72 hours : Absent
|
29 Participants
|
39 Participants
|
37 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
72 hours : Present
|
22 Participants
|
14 Participants
|
14 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
72 hours : Missing
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Day 8 : Absent
|
43 Participants
|
43 Participants
|
40 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Day 8 : Present
|
6 Participants
|
9 Participants
|
9 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Day 8 : Missing
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Day 15 : Absent
|
47 Participants
|
47 Participants
|
40 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Day 15 : Present
|
2 Participants
|
5 Participants
|
9 Participants
|
|
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Day 15 : Missing
|
6 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study5-point Likert scale (0- to 4-point scale: 0=excellent, 1=very good, 2=good, 3=fair, 4=poor response to treatment) where lower rate indicates better response to treatment
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
72 hours : Excellent
|
11 Participants
|
10 Participants
|
18 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
72 hours : Very good
|
13 Participants
|
19 Participants
|
9 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
72 hours : Good
|
7 Participants
|
14 Participants
|
15 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
72 hours : Fair
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
72 hours : Poor
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
72 hours : Missing
|
13 Participants
|
8 Participants
|
8 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 8 : Excellent
|
9 Participants
|
16 Participants
|
19 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 8 : Very good
|
16 Participants
|
21 Participants
|
13 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 8 : Good
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 8 : Fair
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 8 : Poor
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 8 : Missing
|
12 Participants
|
7 Participants
|
12 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 15 : Excellent
|
14 Participants
|
19 Participants
|
21 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 15 : Very good
|
9 Participants
|
13 Participants
|
11 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 15 : Good
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 15 : Fair
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 15 : Poor
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Day 15 : Missing
|
13 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the studyPopulation: Some patients did not undertake all assessments.
This endpoint represents the change from baseline, mg/dL, of the inflammatory biomarker C reactive protein
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Change From Baseline in the Inflammatory Biomarker C Reactive Protein
72 hours
|
-0.362 mg/dL
Standard Deviation 3.435
|
-1.435 mg/dL
Standard Deviation 2.057
|
-1.362 mg/dL
Standard Deviation 1.682
|
|
Change From Baseline in the Inflammatory Biomarker C Reactive Protein
Day 8
|
-0.321 mg/dL
Standard Deviation 2.153
|
-1.334 mg/dL
Standard Deviation 2.702
|
1.406 mg/dL
Standard Deviation 1.961
|
|
Change From Baseline in the Inflammatory Biomarker C Reactive Protein
Day 15
|
-1.102 mg/dL
Standard Deviation 1.690
|
-0.724 mg/dL
Standard Deviation 2.525
|
-0.607 mg/dL
Standard Deviation 2.646
|
SECONDARY outcome
Timeframe: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the studyPopulation: Some patients did not undertake all assessments.
This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Change From Baseline in the Inflammatory Biomarker Serum Amyloid A
72 hours
|
8.950 mg/L
Standard Deviation 246.317
|
-45.160 mg/L
Standard Deviation 126.986
|
-34.510 mg/L
Standard Deviation 58.518
|
|
Change From Baseline in the Inflammatory Biomarker Serum Amyloid A
Day 8
|
-6.363 mg/L
Standard Deviation 117.794
|
-46.561 mg/L
Standard Deviation 144.630
|
-35.887 mg/L
Standard Deviation 64.144
|
|
Change From Baseline in the Inflammatory Biomarker Serum Amyloid A
Day 15
|
-50.524 mg/L
Standard Deviation 105.170
|
-25.328 mg/L
Standard Deviation 144.039
|
14.370 mg/L
Standard Deviation 146.627
|
SECONDARY outcome
Timeframe: Through study completion, at 12 weeks after last flare treated during the extension periodAll adverse events to be recorded Day 1 - Day 28 for each flare. Serious adverse events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence.
Outcome measures
| Measure |
Triamcinolone 40 mg
n=54 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=55 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=52 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
The Percent of Patients With at Least One Adverse Event
|
40.7 Percent
|
38.2 Percent
|
55.8 Percent
|
SECONDARY outcome
Timeframe: Through study completion, at 12 weeks after last flare treated during the extension periodSerious Adverse Events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence.
Outcome measures
| Measure |
Triamcinolone 40 mg
n=54 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=55 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=52 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
The Percent of Patients With at Least One Serious Adverse Event, Including Death
|
0 Percent
|
7.3 Percent
|
0 Percent
|
SECONDARY outcome
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension periodPopulation: Some patients did not undertake all assessments.
This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra
Outcome measures
| Measure |
Triamcinolone 40 mg
n=54 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=55 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=52 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
First flare : Baseline
|
2.032 ng/mL
Standard Deviation 2.493
|
4.883 ng/mL
Standard Deviation 24.378
|
1.950 ng/mL
Standard Deviation 2.755
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
First flare : 72 hours
|
1.974 ng/mL
Standard Deviation 1.793
|
267.744 ng/mL
Standard Deviation 246.086
|
628.053 ng/mL
Standard Deviation 540.488
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
First flare : Day 8
|
1.692 ng/mL
Standard Deviation 1.343
|
6.750 ng/mL
Standard Deviation 10.439
|
34.777 ng/mL
Standard Deviation 87.812
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
First flare : Day 15
|
1.533 ng/mL
Standard Deviation 0.226
|
1.588 ng/mL
Standard Deviation 0.443
|
1.574 ng/mL
Standard Deviation 0.356
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
First flare : Day 28
|
1.635 ng/mL
Standard Deviation 0.615
|
1.659 ng/mL
Standard Deviation 1.057
|
1.779 ng/mL
Standard Deviation 0.895
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
First flare : Week 12
|
1.500 ng/mL
Standard Deviation 0.000
|
1.625 ng/mL
Standard Deviation 0.478
|
1.719 ng/mL
Standard Deviation 0.681
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Second flare : Baseline
|
1.748 ng/mL
Standard Deviation 1.024
|
1.718 ng/mL
Standard Deviation 0.732
|
1.500 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Second flare : 72 hours
|
1.628 ng/mL
Standard Deviation 0.526
|
254.930 ng/mL
Standard Deviation 249.962
|
719.667 ng/mL
Standard Deviation 840.530
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Second flare : Day 8
|
3.141 ng/mL
Standard Deviation 6.270
|
7.048 ng/mL
Standard Deviation 20.338
|
48.785 ng/mL
Standard Deviation 114.114
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Second flare : Day 15
|
1.845 ng/mL
Standard Deviation 1291
|
1.595 ng/mL
Standard Deviation 0.457
|
1.500 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Second flare : Day 28
|
1.975 ng/mL
Standard Deviation 1.714
|
1.692 ng/mL
Standard Deviation 0.882
|
1.500 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Second flare : Week 12
|
2.920 ng/mL
Standard Deviation 4.490
|
1.681 ng/mL
Standard Deviation 0.725
|
1.692 ng/mL
Standard Deviation 0.636
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Third flare : Baseline
|
2.05 ng/mL
Standard Deviation 1.24
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Third flare : 72 hours
|
1.85 ng/mL
Standard Deviation 0.78
|
196.67 ng/mL
Standard Deviation 192.56
|
431.63 ng/mL
Standard Deviation 298.51
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Third flare : Day 8
|
1.50 ng/mL
Standard Deviation 0.00
|
5.56 ng/mL
Standard Deviation 12.97
|
10.70 ng/mL
Standard Deviation 15.42
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Third flare : Day 15
|
1.50 ng/mL
Standard Deviation 0.00
|
1.63 ng/mL
Standard Deviation 0.44
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Third flare : Day 28
|
1.85 ng/mL
Standard Deviation 0.78
|
1.50 ng/mL
Standard Deviation 0.00
|
2.47 ng/mL
Standard Deviation 2.38
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Third flare : Week 12
|
2.85 ng/mL
Standard Deviation 1.91
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fourth flare : Baseline
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fourth flare : 72 hours
|
1.50 ng/mL
Standard Deviation 0.00
|
184.40 ng/mL
Standard Deviation 198.19
|
916.62 ng/mL
Standard Deviation 1549.55
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fourth flare : Day 8
|
1.50 ng/mL
Standard Deviation 0.00
|
1.89 ng/mL
Standard Deviation 1.02
|
20.62 ng/mL
Standard Deviation 34.10
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fourth flare : Day 15
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fourth flare : Day 28
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fourth flare : Week 12
|
1.50 ng/mL
Standard Deviation 0.00
|
2.66 ng/mL
Standard Deviation 2.60
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fifth flare : Baseline
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fifthe flare : 72 hours
|
1.50 ng/mL
Standard Deviation 0.00
|
129.20 ng/mL
Standard Deviation 200.26
|
292.35 ng/mL
Standard Deviation 308.56
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fifthe flare : Day 8
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
6.39 ng/mL
Standard Deviation 9.49
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fifthe flare : Day 15
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fifthe flare : Day 28
|
1.50 ng/mL
Standard Deviation 0.00
|
3.31 ng/mL
Standard Deviation 2.55
|
1.50 ng/mL
Standard Deviation 0.00
|
|
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
Fifth flare : Week 12
|
1.50 ng/mL
Standard Deviation 0.00
|
—
|
1.50 ng/mL
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated treated during the extension periodPopulation: Some patients did not undertake all assessments.
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Outcome measures
| Measure |
Triamcinolone 40 mg
n=54 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=55 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=52 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
First flare : Baseline
|
2 participants
|
5 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
First flare : Day 8
|
1 participants
|
4 participants
|
3 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
First flare : Day 15
|
0 participants
|
5 participants
|
4 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
First flare : Day 28
|
0 participants
|
4 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
First flare : Week 12
|
0 participants
|
4 participants
|
0 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Second flare : Baseline
|
0 participants
|
0 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Second flare : Day 8
|
0 participants
|
1 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Second flare : Day 15
|
0 participants
|
1 participants
|
0 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Second flare : Day 28
|
0 participants
|
1 participants
|
1 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Second flare : Week 12
|
0 participants
|
0 participants
|
1 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Third flare : Baseline
|
0 participants
|
0 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Third flare : Day 8
|
0 participants
|
1 participants
|
4 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Third flare : Day 15
|
0 participants
|
1 participants
|
4 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Third flare : Day 28
|
0 participants
|
1 participants
|
0 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Third flare : Week 12
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fourth flare : Baseline
|
0 participants
|
0 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fourth flare : Day 8
|
0 participants
|
1 participants
|
3 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fourth flare : Day 15
|
0 participants
|
1 participants
|
4 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fourth flare : Day 28
|
0 participants
|
1 participants
|
1 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fourth flare : Week 12
|
0 participants
|
1 participants
|
0 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fifth flare : Baseline
|
0 participants
|
0 participants
|
1 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fifth flare : Day 8
|
0 participants
|
1 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fifth flare : Day 15
|
0 participants
|
2 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fifth flare : Day 28
|
0 participants
|
1 participants
|
2 participants
|
|
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Fifth flare : Week 12
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension periodPopulation: Some patients did not undertake all assessments.
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Outcome measures
| Measure |
Triamcinolone 40 mg
n=54 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=55 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=52 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Proportion of Patients With Neutralizing Antibodies
Third flare : Flare baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Third flare : Day 8
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Third flare : Day 15
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Third flare : Day 28
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Third flare : Week 12
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fourth flare : Study baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fourth flare : Flare baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fourth flare : Day 8
|
0 participants
|
1 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fourth flare : Day 15
|
0 participants
|
0 participants
|
1 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fourth flare : Day 28
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fourth flare : Week 12
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fifth flare : Study baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fifth flare : Flare baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fifth flare : Day 8
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fifth flare : Day 15
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fifth flare : Day 28
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Fifth flare : Week 12
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
First flare : Baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
First flare : Day 8
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
First flare : Day 15
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
First flare : Day 28
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
First flare : Week 12
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Second flare : Study baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Second flare : Flare baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Second flare : Day 8
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Second flare : Day 15
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Second flare : Day 28
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Second flare : Week 12
|
0 participants
|
0 participants
|
0 participants
|
|
Proportion of Patients With Neutralizing Antibodies
Third flare : Study baseline
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at baseline, Day 8 and Day 15 for the first flare treated in the studyPopulation: Some patients did not undertake all assessments.
SF-36® measures the impact of disease on overall quality of life. It consists of 8 individual domains. Score range from 0 to 100, where 0 represents the worst possible health and 100 is perfect health.
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score
Day 8
|
8.0 units on a scale
Standard Deviation 9.8
|
10.5 units on a scale
Standard Deviation 10.0
|
10.4 units on a scale
Standard Deviation 8.3
|
|
Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score
Day 15
|
11.8 units on a scale
Standard Deviation 8.2
|
12.2 units on a scale
Standard Deviation 11.9
|
9.4 units on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: at baseline, Day 8 and Day 15 for the first flare treated in the studyExploratory objective. The EQ-5D-5L, a self-report questionnaire, is a descriptive system of Health related quality of life (HRQL) states consisting of 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression), each of which can have 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Missing
|
17 Participants
|
12 Participants
|
11 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Improvement 4 step
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Improvement 3 step
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Improvement 2 step
|
12 Participants
|
9 Participants
|
11 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Improvement 1 step
|
5 Participants
|
18 Participants
|
12 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · No change
|
14 Participants
|
7 Participants
|
9 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Deterioration 1 steps
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Deterioration 2 steps
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 8 · Missing
|
14 Participants
|
9 Participants
|
15 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Improvement 4 step
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Improvement 3 step
|
7 Participants
|
7 Participants
|
2 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Improvement 2 step
|
11 Participants
|
10 Participants
|
15 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Improvement 1 step
|
8 Participants
|
16 Participants
|
10 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · No change
|
9 Participants
|
5 Participants
|
14 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Deterioration 1 steps
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Deterioration 2 steps
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Mobility scores : Day 15 · Missing
|
17 Participants
|
12 Participants
|
11 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Improvement 4 step
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Improvement 3 step
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Improvement 2 step
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Improvement 1 step
|
7 Participants
|
11 Participants
|
6 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · No change
|
23 Participants
|
27 Participants
|
22 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Deterioration 1 steps
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Deterioration 2 steps
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Self-care scores : Day 8 · Missing
|
14 Participants
|
9 Participants
|
15 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Improvement 4 step
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Improvement 3 step
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Improvement 2 step
|
5 Participants
|
5 Participants
|
7 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Improvement 1 step
|
8 Participants
|
10 Participants
|
10 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · No change
|
20 Participants
|
21 Participants
|
25 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Deterioration 1 steps
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Deterioration 2 steps
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Selfcare scores : Day 15 · Missing
|
17 Participants
|
12 Participants
|
11 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Improvement 4 step
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Improvement 3 step
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Improvement 2 step
|
15 Participants
|
11 Participants
|
13 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Improvement 1 step
|
10 Participants
|
14 Participants
|
9 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · No change
|
6 Participants
|
12 Participants
|
14 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Deterioration 1 steps
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Deterioration 2 steps
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 8 · Missing
|
14 Participants
|
9 Participants
|
15 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Improvement 4 step
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Improvement 3 step
|
8 Participants
|
7 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Improvement 2 step
|
10 Participants
|
11 Participants
|
13 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Improvement 1 step
|
10 Participants
|
12 Participants
|
13 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · No change
|
6 Participants
|
9 Participants
|
14 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Deterioration 1 steps
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Deterioration 2 steps
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Usual activities scores : Day 15 · Missing
|
17 Participants
|
12 Participants
|
11 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Improvement 4 step
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Improvement 3 step
|
5 Participants
|
11 Participants
|
11 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Improvement 2 step
|
16 Participants
|
12 Participants
|
15 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Improvement 1 step
|
12 Participants
|
15 Participants
|
9 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · No change
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Deterioration 1 steps
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Deterioration 2 steps
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 8 · Missing
|
14 Participants
|
9 Participants
|
15 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Improvement 4 step
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Improvement 3 step
|
9 Participants
|
11 Participants
|
10 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Improvement 2 step
|
17 Participants
|
13 Participants
|
14 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Improvement 1 step
|
5 Participants
|
11 Participants
|
10 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · No change
|
3 Participants
|
2 Participants
|
8 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Deterioration 1 steps
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Deterioration 2 steps
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Pain/discomfort scores : Day 15 · Missing
|
17 Participants
|
12 Participants
|
11 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Improvement 4 step
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Improvement 3 step
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Improvement 2 step
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Improvement 1 step
|
5 Participants
|
9 Participants
|
9 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · No change
|
26 Participants
|
33 Participants
|
25 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Deterioration 1 steps
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Deterioration 2 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 8 · Missing
|
14 Participants
|
9 Participants
|
15 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Improvement 4 step
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Improvement 3 step
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Improvement 2 step
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Improvement 1 step
|
7 Participants
|
6 Participants
|
10 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · No change
|
23 Participants
|
33 Participants
|
26 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Deterioration 1 steps
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Deterioration 2 steps
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Deterioration 3 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Anxiety/depression scores : Day 15 · Detorioration 4 steps
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension periodPopulation: Some patients did not undertake all assessments.
The WPAI yeilds four types of scores of which Work productivity loss is one. SHP is derived from WPAI as follows: The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows: Questions: Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities Scores: Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working). Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10.
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
First flare : Day 8
|
36.1 percent
Standard Deviation 34.3
|
32.6 percent
Standard Deviation 29.1
|
20.5 percent
Standard Deviation 25.0
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
First flare : Day 15
|
23.3 percent
Standard Deviation 24.8
|
12.6 percent
Standard Deviation 20.7
|
21.6 percent
Standard Deviation 22.3
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Second flare : Day 8
|
42.9 percent
Standard Deviation 27.5
|
24.0 percent
Standard Deviation 26.3
|
24.0 percent
Standard Deviation 27.2
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Second flare : Day 15
|
16.0 percent
Standard Deviation 25.1
|
20.0 percent
Standard Deviation 17.6
|
13.8 percent
Standard Deviation 16.9
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Third flare : Day 8
|
10.0 percent
|
5.0 percent
Standard Deviation 7.1
|
10.0 percent
Standard Deviation 10.0
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Third flare : Day 15
|
10.0 percent
|
20.0 percent
Standard Deviation 24.5
|
23.3 percent
Standard Deviation 32.1
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Fourth flare : Day 8
|
30.0 percent
|
—
|
20.0 percent
Standard Deviation 34.6
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Fourth flare : Day 15
|
—
|
—
|
5.0 percent
Standard Deviation 7.1
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Fifth flare : Day 8
|
60.0 percent
|
—
|
26.7 percent
Standard Deviation 25.2
|
|
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Fifth flare : Day 15
|
20.0 percent
|
40.0 percent
|
13.3 percent
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension periodPopulation: Some patients did not undertake all assessments.
Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits
Outcome measures
| Measure |
Triamcinolone 40 mg
n=55 Participants
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=56 Participants
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=54 Participants
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : First flare : Day 1-7
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : First flare : Day 8-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : First flare : Day 1-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Second flare : Day 1-7
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Second flare : Day 8-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Second flare : Day 1-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Third flare : Day 1-7
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Third flare : Day 8-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Third flare : Day 1-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Fourth flare : Day 1-7
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Fourth flare : Day 8-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Fourth flare : Day 1-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Fifth flare : Day 1-7
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Fifth flare : Day 8-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Hospitalization : Fifth flare : Day 1-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visits:First flare: Day 1-7
|
0.1 days
Standard Deviation 0.5
|
0 days
Standard Deviation 0
|
0.1 days
Standard Deviation 0.6
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visits:First flare:Day 8-15
|
0.3 days
Standard Deviation 1.4
|
0.1 days
Standard Deviation 0.6
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visits:First flare:Day 1-15
|
0.4 days
Standard Deviation 1.4
|
0.1 days
Standard Deviation 0.6
|
0.1 days
Standard Deviation 0.6
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visits:Second flare:Day 1-7
|
0.2 days
Standard Deviation 0.8
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visit:Second flare:Day 8-15
|
0.2 days
Standard Deviation 0.6
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visit:Second flare:Day 1-15
|
0.5 days
Standard Deviation 1.5
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visits:Third flare:Day 1-7
|
0.4 days
Standard Deviation 0.9
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visits:Third flare:Day 8-15
|
0.4 days
Standard Deviation 0.9
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visits:Third flare:Day 1-15
|
0.8 days
Standard Deviation 1.8
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visitstFourth flare:Day 1-7
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visitsFourth flare:Day 8-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visitsFourth flare:Day 1-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visit:Fifth flare : Day 1-7
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visitFifth flare : Day 8-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Unscheduled outpatient visit Fifth flare:Day 1-15
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
Adverse Events
Triamcinolone 40 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Anakinra 100 mg
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Anakinra 200 mg
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triamcinolone 40 mg
n=54 participants at risk
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=55 participants at risk
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=52 participants at risk
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Nervous system disorders
Seizure
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Congenital, familial and genetic disorders
Sickel cell anaemia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
Other adverse events
| Measure |
Triamcinolone 40 mg
n=54 participants at risk
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg
Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
|
Anakinra 100 mg
n=55 participants at risk
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
Anakinra 200 mg
n=52 participants at risk
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
5.5%
3/55 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
9.6%
5/52 • Number of events 9 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Bronchitis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Infections and infestations
Tooth infection
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
5.8%
3/52 • Number of events 5 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
5.5%
3/55 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Psychiatric disorders
Stress
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Psychiatric disorders
Anger
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Psychiatric disorders
Delirium
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Nervous system disorders
Headache
|
3.7%
2/54 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Nervous system disorders
Seizure
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Nervous system disorders
Somnolence
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Eye disorders
Vitreous floaters
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Vascular disorders
Hypertension
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Vascular disorders
Aortic arteriosclerosis
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Vascular disorders
Flushing
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.6%
2/55 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 6 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.6%
2/55 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Renal and urinary disorders
Renal impairment
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Congenital, familial and genetic disorders
Type IIa hyperlipidaemia
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Oedema peripheral
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site erythema
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Fatigue
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site reaction
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Pyrexia
|
3.7%
2/54 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site pruritus
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site swelling
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site haematoma
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site induration
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Gait disturbance
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Injection site pain
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
General disorders
Impaired healing
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
Blood pressure increased
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
Glomerular filtration rate decreased
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
Troponin T increased
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
Albumin urine present
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
Blood creatinine increased
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.8%
1/55 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
White blood cell count increased
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/52 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Investigations
Blood triglycerides increased
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
9.6%
5/52 • Number of events 14 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 2 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
3.8%
2/52 • Number of events 3 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.9%
1/54 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Cardiac contusion
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/54 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
0.00%
0/55 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
1.9%
1/52 • Number of events 1 • The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
|
Additional Information
Kineret Clinical Program Leader
Swedish Orphan Biovitrum
Phone: +46(8)6972000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place