Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD) (NCT NCT03265132)
NCT ID: NCT03265132
Last Updated: 2021-06-30
Results Overview
ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. (ACR: American College of Rheumatology) 1. Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm). 2. Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm). 3. Number of joints with active arthritis. 4. Number of joints with limitation of motion. 5. Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ). 6. C-Reactive Protein (CRP) (mg/L).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
Week 2
Results posted on
2021-06-30
Participant Flow
Participant milestones
| Measure |
Anakinra
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Anakinra
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Progressive disease
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
12.3 years
STANDARD_DEVIATION 19.3 • n=107 Participants
|
13.3 years
STANDARD_DEVIATION 16.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Still's disease symptom duration
|
32.4 Days
STANDARD_DEVIATION 18.7 • n=99 Participants
|
109.0 Days
STANDARD_DEVIATION 78.0 • n=107 Participants
|
74.2 Days
STANDARD_DEVIATION 69.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 2ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. (ACR: American College of Rheumatology) 1. Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm). 2. Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm). 3. Number of joints with active arthritis. 4. Number of joints with limitation of motion. 5. Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ). 6. C-Reactive Protein (CRP) (mg/L).
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 1ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 1ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Responders in Physician Global Assessment of Disease Activity.
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=4 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Responders in Number of Joints With Active Arthritis.
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 2Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Responders in Number of Joints With Limitation of Motion.
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 2Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Responders in CRP (mg/L).
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Proportion of patients with absence of fever during the 7 days preceding Week 2.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1Absence of fever during the 24 hours preceding week 1.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Week 1Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.
|
-46.3 mm
Standard Deviation 32.6
|
-30.0 mm
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: Day 1 and Week 1Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=4 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.
|
-53.7 mm
Standard Deviation 27.7
|
-25.0 mm
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: Day 1 and Week 1Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in CRP.
|
-109.6 mg/L
Standard Deviation 63.4
|
-22.7 mg/L
Standard Deviation 47.1
|
SECONDARY outcome
Timeframe: Week 12Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8 and Week 12Population: No patients were treated with any systemic glucocorticoids at randomization
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 2Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=4 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Absence of Rash.
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 2Change from baseline in CRP. Results at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in CRP.
|
-126.670 mg/L
Standard Deviation 66.697
|
-33.904 mg/L
Standard Deviation 64.393
|
SECONDARY outcome
Timeframe: Week 2Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=3 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.
|
1.57 g/dL
Standard Deviation 0.86
|
-0.80 g/dL
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Week 2Change from baseline in platelet count. Results at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=3 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Platelet Count.
|
-148.2 10^9/L
Standard Deviation 52.3
|
-26.3 10^9/L
Standard Deviation 139.6
|
SECONDARY outcome
Timeframe: Week 2Change from baseline in ferritin. Results at Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=5 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=3 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Ferritin.
|
-390.364 ug/L
Standard Deviation 387.521
|
-49.383 ug/L
Standard Deviation 51.776
|
SECONDARY outcome
Timeframe: Week 2Population: Patients with baseline and week 2 data analyzed.
Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=4 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.
|
-55.6 score on a scale
Standard Deviation 27.7
|
-33.5 score on a scale
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: From Day 1 to Week12Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Time to Study Drug Discontinuation for Any Reason.
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Week12Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Week 2 to Week12Population: No patients were treated with any systemic glucocorticoids at randomization
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 2 to Week12Population: No patients were treated with any systemic glucocorticoids at randomization
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to Week12Population: No patients were treated with any systemic glucocorticoids at randomization
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to Week 16All adverse events collected from start of study treatment up to 28 days after stopping study treatment.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=6 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With at Least One Adverse Event.
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Informed consent to Week 16Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=6 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With at Least One Serious Adverse Event Including Death.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Week 16Proportion of patients with Macrophage Activation Syndrome (MAS).
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=6 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Macrophage Activation Syndrome (MAS).
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Proportion of patients with antidrug antibodies (ADA) against anakinra.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=6 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 2Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=6 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Neutralizing Antibodies.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Population: No data available for the placebo group as they did not receive anakinra.
Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=4 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Anakinra Serum Pre-dose Concentrations.
|
157 ng/mL
Standard Deviation 134
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: PK parameters only available for 2 anakinra treated patients.
PK parameters only available for 2 patients.
Outcome measures
| Measure |
Anakinra
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=2 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Anakinra Serum Pharmacokinetic Parameters: Cmax,
|
—
|
1990.0 ng/mL
Standard Deviation 1315.2
|
SECONDARY outcome
Timeframe: Week 12Population: PK parameters only available for 2 patients
PK parameters only available for 2 patients
Outcome measures
| Measure |
Anakinra
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=2 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Anakinra Serum Pharmacokinetic Parameters, Tmax and T½
Tmax
|
—
|
3.06 hours
Standard Deviation 1.33
|
|
Anakinra Serum Pharmacokinetic Parameters, Tmax and T½
T½
|
—
|
5.23 hours
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Week 12Population: PK parameters only available for 2 anakinra treated patients
PK parameters only available for 2 patients
Outcome measures
| Measure |
Anakinra
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=2 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h
|
—
|
18483.3 h*ng/mL
Standard Deviation 15708.4
|
SECONDARY outcome
Timeframe: Week 12Population: Pharmacokinetic parameters only available for 2 anakinra treated patients
Pharmacokinetic parameters only available for 2 patients
Outcome measures
| Measure |
Anakinra
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=2 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Anakinra Serum Pharmacokinetic Parameter: CL/F
|
—
|
170.80 mL/h*kg
Standard Deviation 45.69
|
SECONDARY outcome
Timeframe: Week 12Population: PK parameters only available for 2 anakinra treated patients
PK parameters only available for 2 patients
Outcome measures
| Measure |
Anakinra
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=2 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Anakinra Serum Pharmacokinetic Parameter: Vd/F
|
—
|
1254.52 mL/kg
Standard Deviation 95.57
|
SECONDARY outcome
Timeframe: Week 2Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values \<10 mg/l are converted to 10 and CRP values \>110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57. Only results from Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=4 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in JADAS27.
|
-21.42 score on a scale
Standard Deviation 3.93
|
-15.81 score on a scale
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: Week 2Number of days off school or work due to Still's disease week 1-2.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=4 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Number of Days Off School or Work Due to Still's Disease.
|
0.7 Days
Standard Deviation 1.6
|
1.3 Days
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Week 12Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=5 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Proportion of Patients With Inactive Disease.
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Only results from Week 2 reported here.
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=3 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in IL-6.
|
-30.048 ng/L
Standard Deviation 23.262
|
-24.818 ng/L
Standard Deviation 25.940
|
SECONDARY outcome
Timeframe: Week 2Only results from Week 2 reported here
Outcome measures
| Measure |
Anakinra
n=5 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=3 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in IL-18.
|
-7968.0 ng/L
Standard Deviation 7564.4
|
-20701.7 ng/L
Standard Deviation 32766.4
|
SECONDARY outcome
Timeframe: Week 2Change from baseline in serum calprotectin. Only results from Week 2 reported here
Outcome measures
| Measure |
Anakinra
n=6 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=3 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Serum Calprotectin.
|
-100.038 mg/L
Standard Deviation 113.349
|
-26.021 mg/L
Standard Deviation 23.819
|
SECONDARY outcome
Timeframe: Week 2Only results from Week 2 reported here
Outcome measures
| Measure |
Anakinra
n=5 Participants
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=3 Participants
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Change From Baseline in Neopterin.
|
-3.08 nmol/L
Standard Deviation 5.69
|
-8.00 nmol/L
Standard Deviation 10.82
|
Adverse Events
Anakinra
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anakinra
n=6 participants at risk
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=6 participants at risk
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage III
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
Other adverse events
| Measure |
Anakinra
n=6 participants at risk
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
anakinra: sub cutaneous injection
|
Placebo
n=6 participants at risk
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Placebo: sub cutaneous injection
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Infections and infestations
Upper respiratory infection
|
50.0%
3/6 • Number of events 3 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Infections and infestations
Ear infection
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Nervous system disorders
Neuralgia
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
2/6 • Number of events 2 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Gastrointestinal disorders
Retching
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
General disorders
Injection site reaction
|
33.3%
2/6 • Number of events 2 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
General disorders
Injection site rash
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Investigations
Vitamin D decrease
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
16.7%
1/6 • Number of events 1 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
0.00%
0/6 • From the start of study treatment up to 28 days after stopping study treatment.
The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
|
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