Trial Outcomes & Findings for Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients (NCT NCT01356602)
NCT ID: NCT01356602
Last Updated: 2014-01-29
Results Overview
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
COMPLETED
PHASE3
397 participants
72 hours post dose
2014-01-29
Participant Flow
Number of subjects randomized was 397. Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to a safety set of 399 subjects. Subjects who did not receive study drug were excluded from analysis.
Participant milestones
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
132
|
132
|
|
Overall Study
Safety Set
|
133
|
133
|
133
|
|
Overall Study
Full Analysis Set
|
131
|
129
|
129
|
|
Overall Study
COMPLETED
|
124
|
117
|
108
|
|
Overall Study
NOT COMPLETED
|
9
|
15
|
24
|
Reasons for withdrawal
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Overall Study
Protocol Deviation
|
0
|
1
|
1
|
|
Overall Study
Administrative Problems
|
1
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
7
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Baseline characteristics by cohort
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=133 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=133 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=133 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.4 Years
STANDARD_DEVIATION 11.21 • n=39 Participants
|
53 Years
STANDARD_DEVIATION 11.84 • n=41 Participants
|
53.7 Years
STANDARD_DEVIATION 11.33 • n=35 Participants
|
53.5 Years
STANDARD_DEVIATION 11.44 • n=31 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=39 Participants
|
124 Participants
n=41 Participants
|
122 Participants
n=35 Participants
|
364 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 72 hours post dosePopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=130 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=126 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
|
17.1 Millimeters
Standard Error 2.04
|
—
|
32 Millimeters
Standard Error 2.08
|
SECONDARY outcome
Timeframe: 72 hours post dosePopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=130 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
|
17.1 Millimeters
Standard Error 2.04
|
19.7 Millimeters
Standard Error 2.05
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=130 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=126 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Patient's Assessment of Pain Intensity on a 0-100mm VAS
|
7.9 Millimeters
Standard Error 1.69
|
8.2 Millimeters
Standard Error 1.7
|
14.8 Millimeters
Standard Error 1.72
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=128 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Patient's Assessment of Pain Intensity on a 5-point Likert Scale
None
|
35.9 Percentage of Patients
|
32.6 Percentage of Patients
|
23.4 Percentage of Patients
|
|
Patient's Assessment of Pain Intensity on a 5-point Likert Scale
Mild
|
45.8 Percentage of Patients
|
44.2 Percentage of Patients
|
36.7 Percentage of Patients
|
|
Patient's Assessment of Pain Intensity on a 5-point Likert Scale
Moderate
|
15.3 Percentage of Patients
|
21.7 Percentage of Patients
|
21.9 Percentage of Patients
|
|
Patient's Assessment of Pain Intensity on a 5-point Likert Scale
Severe
|
2.3 Percentage of Patients
|
1.6 Percentage of Patients
|
14.1 Percentage of Patients
|
|
Patient's Assessment of Pain Intensity on a 5-point Likert Scale
Extreme
|
0.8 Percentage of Patients
|
0 Percentage of Patients
|
3.9 Percentage of Patients
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
|
12 Particpants
|
12 Particpants
|
52 Particpants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Time to the First New Gouty Arthritis Flare
|
NA Days
Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
|
NA Days
Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
|
NA Days
Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=130 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
|
24 Hours
Interval 22.0 to 25.0
|
25 Hours
Interval 24.0 to 48.0
|
48 Hours
Interval 25.0 to 54.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=128 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Time to Resolution of Gouty Arthritis Flare as Reported by Patient
|
142 Hours
Interval 96.0 to 168.0
|
120 Hours
Interval 96.0 to 145.0
|
170 Hours
Interval 144.0 to 216.0
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
Excellent
|
36.0 Percentage of Participants
|
34.8 Percentage of Participants
|
20.4 Percentage of Participants
|
|
Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
Good
|
43.2 Percentage of Participants
|
36.5 Percentage of Participants
|
31.9 Percentage of Participants
|
|
Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
Acceptable
|
10.4 Percentage of Participants
|
20.0 Percentage of Participants
|
21.2 Percentage of Participants
|
|
Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
Slight
|
6.4 Percentage of Participants
|
7.8 Percentage of Participants
|
14.2 Percentage of Participants
|
|
Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
Poor
|
4.0 Percentage of Participants
|
0.9 Percentage of Participants
|
12.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
Very good
|
46.2 Percentage of Participants
|
33.6 Percentage of Participants
|
21.5 Percentage of Participants
|
|
Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
Good
|
35.4 Percentage of Participants
|
48.8 Percentage of Participants
|
33.9 Percentage of Participants
|
|
Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
Fair
|
15.4 Percentage of Participants
|
16.0 Percentage of Participants
|
23.1 Percentage of Participants
|
|
Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
Poor
|
1.5 Percentage of Participants
|
1.6 Percentage of Participants
|
14.0 Percentage of Participants
|
|
Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
Very poor
|
1.5 Percentage of Participants
|
0.0 Percentage of Participants
|
7.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Physician's Assessment of Tenderness
No pain
|
50.0 Percentage of Participants
|
40.0 Percentage of Participants
|
29.8 Percentage of Participants
|
|
Physician's Assessment of Tenderness
There is pain
|
43.1 Percentage of Participants
|
52.8 Percentage of Participants
|
47.1 Percentage of Participants
|
|
Physician's Assessment of Tenderness
There is pain and winces
|
5.4 Percentage of Participants
|
6.4 Percentage of Participants
|
14.0 Percentage of Participants
|
|
Physician's Assessment of Tenderness
There is pain, winces and withdraws
|
1.5 Percentage of Participants
|
0.8 Percentage of Participants
|
9.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Physician's Assessment of Swelling
No swelling
|
60.8 Percentage of Partipants
|
55.2 Percentage of Partipants
|
51.2 Percentage of Partipants
|
|
Physician's Assessment of Swelling
Palpable
|
26.9 Percentage of Partipants
|
25.6 Percentage of Partipants
|
15.7 Percentage of Partipants
|
|
Physician's Assessment of Swelling
Visible
|
10.8 Percentage of Partipants
|
17.6 Percentage of Partipants
|
24.8 Percentage of Partipants
|
|
Physician's Assessment of Swelling
Bulging beyond the joint margins
|
1.5 Percentage of Partipants
|
1.6 Percentage of Partipants
|
8.3 Percentage of Partipants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Physician's Assessment of Erythema
Absent
|
88.3 Percentage of Participants
|
82.9 Percentage of Participants
|
68.6 Percentage of Participants
|
|
Physician's Assessment of Erythema
Present
|
11.7 Percentage of Participants
|
17.1 Percentage of Participants
|
31.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Physician's Assessment of Range of Motion of the Most Affected Joint
Normal
|
50.0 Percentage of Participants
|
44.8 Percentage of Participants
|
35.5 Percentage of Participants
|
|
Physician's Assessment of Range of Motion of the Most Affected Joint
Mildly restricted
|
37.7 Percentage of Participants
|
40.8 Percentage of Participants
|
37.2 Percentage of Participants
|
|
Physician's Assessment of Range of Motion of the Most Affected Joint
Moderately restricted
|
11.5 Percentage of Participants
|
12.0 Percentage of Participants
|
14.0 Percentage of Participants
|
|
Physician's Assessment of Range of Motion of the Most Affected Joint
Severely restricted
|
0.8 Percentage of Participants
|
2.4 Percentage of Participants
|
12.4 Percentage of Participants
|
|
Physician's Assessment of Range of Motion of the Most Affected Joint
Immobilized
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Patients used a diary to record the time of intake of rescue medication and the amount taken.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Proportion of Patients With Rescue Medication Intake
|
29.0 Percentage of Particpants
|
31.8 Percentage of Particpants
|
45.7 Percentage of Particpants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Patients used a diary to record the time of intake of rescue medication and the amount taken.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=38 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=40 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=59 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Time to First Rescue Medication Intake
|
11 Hours
Full Range 61.87 • Interval 4.0 to 279.0
|
7.5 Hours
Full Range 31.59 • Interval 3.0 to 142.0
|
11 Hours
Full Range 39.06 • Interval 1.0 to 186.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Patients used a diary to record the time of intake of rescue medication and the amount taken.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=129 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Amount of Rescue Medication Taken (mg)
Acetaminophen
|
609.2 milligrams (mg)
Standard Deviation 1800.06
|
1108.3 milligrams (mg)
Standard Deviation 2821.54
|
2323.1 milligrams (mg)
Standard Deviation 5580.82
|
|
Amount of Rescue Medication Taken (mg)
Codeine
|
12.7 milligrams (mg)
Standard Deviation 55.30
|
23.9 milligrams (mg)
Standard Deviation 124.56
|
60.8 milligrams (mg)
Standard Deviation 191.2
|
|
Amount of Rescue Medication Taken (mg)
Prednisolone / Prednisone
|
5.8 milligrams (mg)
Standard Deviation 23.13
|
6.7 milligrams (mg)
Standard Deviation 25.09
|
24.7 milligrams (mg)
Standard Deviation 53.20
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
A central laboratory was used for analysis of all blood samples collected.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=123 Participants
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=119 Participants
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=118 Participants
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
C-reactive Protein Level
|
3.65 mg / L
Interval 3.11 to 4.29
|
3.37 mg / L
Interval 2.86 to 3.96
|
5.2 mg / L
Interval 4.41 to 6.13
|
Adverse Events
Canakinumab, Pre-filled Syringes (PFS)
Canakinumab, Lyophilizate (LYO)
Triamcinolone Acetonide
Serious adverse events
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=133 participants at risk
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
|
Canakinumab, Lyophilizate (LYO)
n=133 participants at risk
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
|
Triamcinolone Acetonide
n=133 participants at risk
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
|
|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
General disorders
Chest pain
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
General disorders
Drug ineffective
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Infections and infestations
Viral infection
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Nervous system disorders
Migraine
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Psychiatric disorders
Delirium
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Psychiatric disorders
Depression
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
|
Vascular disorders
Aortitis
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.75%
1/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
0.00%
0/133 • 12 weeks
Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
- Publication restrictions are in place
Restriction type: OTHER