Trial Outcomes & Findings for Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients (NCT NCT01431638)
NCT ID: NCT01431638
Last Updated: 2021-07-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
397 participants
Primary outcome timeframe
From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Results posted on
2021-07-19
Participant Flow
This study was conducted at 68 centers at Canada, Germany, Lithuania, United States from 25-August-2011 (first participant first visit) to 09-May-2013 (last participant last visit).
A total of 397 participants were randomized in the core study (CACZ885H2361 \[NCT01356602\]), out of which 232 participants entered the extension study (CACZ885H2361E1 \[NCT01431638\]).
Participant milestones
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
Participants 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.
|
Triamcinolone Acetonide
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
132
|
132
|
|
Overall Study
Completed Core Study
|
124
|
117
|
108
|
|
Overall Study
Entered Extension 1 Study
|
85
|
71
|
76
|
|
Overall Study
COMPLETED
|
67
|
61
|
70
|
|
Overall Study
NOT COMPLETED
|
66
|
71
|
62
|
Reasons for withdrawal
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
Participants 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.
|
Triamcinolone Acetonide
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
2
|
2
|
4
|
|
Overall Study
Participants condition no longer requires study drug
|
0
|
1
|
0
|
|
Overall Study
Participant withdrew consent
|
14
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
7
|
|
Overall Study
Administrative problems
|
1
|
4
|
6
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Protocol deviation
|
1
|
1
|
4
|
|
Overall Study
Participants Did not enter extension study from core study
|
39
|
46
|
32
|
Baseline Characteristics
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Baseline characteristics by cohort
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=133 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=132 Participants
Participants 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.
|
Triamcinolone Acetonide
n=132 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
Total
n=397 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 65 years
|
113 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
327 Participants
n=4 Participants
|
|
Age, Customized
>= 65-74 years
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Age, Customized
>= 75 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
363 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
93 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native american
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Pacific islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)Population: Safety Set consisted of all participants that received study drug in the core study (CACZ885H2361 \[NCT01356602\]) and had at least one post-baseline safety assessment. The patients with more than one treatment are counted in the Safety Set under those treatment groups as the actual treatments they received. Thus, the number of subjects in the treatment arms are more than the number of randomized subjects.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=133 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=133 Participants
Participants 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.
|
Triamcinolone Acetonide
n=133 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Number of Participants Who Reported Adverse Events
|
78 Participants
|
65 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Up to Day 337Population: Full Analysis Set (FAS) consisted of all participants randomized in the core study (CACZ885H2361 \[NCT01356602\]) that had taken at least one dose of study drug.
The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
Participants 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.
|
Triamcinolone Acetonide
n=129 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Probability of New Gout Flares at End of Study
|
65.50 Probability
Interval 54.97 to 75.81
|
75.42 Probability
Interval 63.82 to 85.57
|
72.95 Probability
Interval 62.95 to 82.12
|
SECONDARY outcome
Timeframe: up to 36 weeksPopulation: FAS consisted of all participants randomized in the core study (CACZ885H2361 \[NCT01356602\]) that had taken at least one dose of study drug.
The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=131 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=129 Participants
Participants 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.
|
Triamcinolone Acetonide
n=129 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Number of Participant With New Flares
One new flare
|
35 Participants
|
46 Participants
|
36 Participants
|
|
Number of Participant With New Flares
Two new flares
|
17 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participant With New Flares
Three new flares
|
2 Participants
|
0 Participants
|
8 Participants
|
|
Number of Participant With New Flares
Greater (>) than three new flares
|
4 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, upto 14 days post-dosePopulation: Modified Analysis Set (MAS) consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (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=42 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=32 Participants
Participants 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.
|
Triamcinolone Acetonide
n=35 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Change From Baseline in Pain Intensity on a 5-point Likert Scale
|
-2.5 units on a scale
Standard Deviation 0.86
|
-2.3 units on a scale
Standard Deviation 0.97
|
-2.7 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dosePopulation: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=41 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=32 Participants
Participants 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.
|
Triamcinolone Acetonide
n=35 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
Baseline
|
74.2 units on a scale
Standard Deviation 14.52
|
75.5 units on a scale
Standard Deviation 14.32
|
74.3 units on a scale
Standard Deviation 14.44
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
6 hours post-dose
|
-12.9 units on a scale
Standard Deviation 21.03
|
-13.0 units on a scale
Standard Deviation 17.14
|
-10.2 units on a scale
Standard Deviation 15.78
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
12 hours post-dose
|
-23.7 units on a scale
Standard Deviation 22.94
|
-26.7 units on a scale
Standard Deviation 22.09
|
-23.4 units on a scale
Standard Deviation 19.87
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
24 hours post-dose
|
-34.9 units on a scale
Standard Deviation 24.88
|
-36.1 units on a scale
Standard Deviation 24.55
|
-35.6 units on a scale
Standard Deviation 27.09
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
48 hours post-dose
|
-46.4 units on a scale
Standard Deviation 25.31
|
-43.8 units on a scale
Standard Deviation 24.71
|
-51.1 units on a scale
Standard Deviation 26.34
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
72 hours post-dose
|
-55.1 units on a scale
Standard Deviation 26.97
|
-45.8 units on a scale
Standard Deviation 28.74
|
-54.7 units on a scale
Standard Deviation 30.41
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
4 days post-dose
|
-55.7 units on a scale
Standard Deviation 26.91
|
-50.0 units on a scale
Standard Deviation 26.39
|
-62.0 units on a scale
Standard Deviation 23.86
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
5 days post-dose
|
-59.1 units on a scale
Standard Deviation 25.99
|
-54.3 units on a scale
Standard Deviation 25.43
|
-65.2 units on a scale
Standard Deviation 23.78
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
6 days post-dose
|
-61.2 units on a scale
Standard Deviation 25.14
|
-57.0 units on a scale
Standard Deviation 24.27
|
-66.0 units on a scale
Standard Deviation 23.37
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
7 days post-dose
|
-62.1 units on a scale
Standard Deviation 25.09
|
-59.2 units on a scale
Standard Deviation 24.32
|
-66.6 units on a scale
Standard Deviation 22.21
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
8 days post-dose
|
-59.9 units on a scale
Standard Deviation 25.73
|
-60.7 units on a scale
Standard Deviation 24.07
|
-66.8 units on a scale
Standard Deviation 22.83
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
9 days post-dose
|
-63.1 units on a scale
Standard Deviation 23.93
|
-61.1 units on a scale
Standard Deviation 24.34
|
-66.7 units on a scale
Standard Deviation 23.21
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
10 days post-dose
|
-63.0 units on a scale
Standard Deviation 23.89
|
-63.3 units on a scale
Standard Deviation 24.31
|
-67.9 units on a scale
Standard Deviation 22.79
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
11 days post-dose
|
-62.7 units on a scale
Standard Deviation 25.19
|
-64.3 units on a scale
Standard Deviation 23.53
|
-68.7 units on a scale
Standard Deviation 22.04
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
12 days post-dose
|
-63.3 units on a scale
Standard Deviation 26.09
|
-64.3 units on a scale
Standard Deviation 23.91
|
-69.4 units on a scale
Standard Deviation 20.89
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
13 days post-dose
|
-65.6 units on a scale
Standard Deviation 23.25
|
-64.0 units on a scale
Standard Deviation 24.47
|
-69.6 units on a scale
Standard Deviation 20.67
|
|
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
14 days post-dose
|
-64.8 units on a scale
Standard Deviation 24.66
|
-64.8 units on a scale
Standard Deviation 24.15
|
-69.8 units on a scale
Standard Deviation 21.25
|
SECONDARY outcome
Timeframe: 48 weeks post-dosePopulation: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=72 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=16 Participants
Participants 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.
|
Triamcinolone Acetonide
n=25 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Poor
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Excellent
|
50 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Good
|
17 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Acceptable
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Slight
|
3 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 7 days post-dosePopulation: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure and at specific category.
Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. 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. Erythema was assessed as present, absent or not assessable.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=57 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=49 Participants
Participants 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.
|
Triamcinolone Acetonide
n=50 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness Baseline: No Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness Baseline: Pain
|
14 Participants
|
6 Participants
|
14 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness Baseline: Pain and winces
|
17 Participants
|
17 Participants
|
20 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness Baseline: Pain, winces and withdraws
|
26 Participants
|
26 Participants
|
16 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness 7 days post-dose: No Pain
|
42 Participants
|
36 Participants
|
27 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness 7 days post-dose: Pain
|
14 Participants
|
12 Participants
|
16 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness 7 days post-dose: Pain, winces
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness 7 days post-dose: Pain, winces and withdraws
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling Baseline: No swelling
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling Baseline: Palpable
|
9 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling Baseline: Visible
|
35 Participants
|
25 Participants
|
27 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling Baseline: Bulging beyond the joint margins
|
12 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling 7 days post-dose: No swelling
|
46 Participants
|
42 Participants
|
38 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling 7 days post-dose: Palpable
|
8 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling 7 days post-dose: Visible
|
2 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Swelling 7 days post-dose: Bulging beyond the joint margins
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Erythema Baseline: Absent
|
10 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Erythema Baseline: Present
|
46 Participants
|
35 Participants
|
35 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Erythema 7 days post-dose: Absent
|
51 Participants
|
47 Participants
|
44 Participants
|
|
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Erythema 7 days post-dose: Present
|
4 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 7 days post-dosePopulation: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.
Outcome measures
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=53 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=49 Participants
Participants 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.
|
Triamcinolone Acetonide
n=48 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
Very good
|
38 Participants
|
33 Participants
|
32 Participants
|
|
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
Good
|
9 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
Fair
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
Poor
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
Very poor
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Canakinumab, Pre-filled Syringes (PFS)
Serious events: 12 serious events
Other events: 10 other events
Deaths: 1 deaths
Canakinumab, Lyophilizate (LYO)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Triamcinolone Acetonide
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=133 participants at risk
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=132 participants at risk
Participants 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.
|
Triamcinolone Acetonide
n=132 participants at risk
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Cardiac disorders
Cardiac failure
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
General disorders
Chest pain
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
General disorders
Drug ineffective
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Infections and infestations
Pneumonia
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Infections and infestations
Viral infection
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Nervous system disorders
Migraine
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Psychiatric disorders
Delirium
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Psychiatric disorders
Depression
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.75%
1/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Vascular disorders
Aortitis
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.00%
0/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
Other adverse events
| Measure |
Canakinumab, Pre-filled Syringes (PFS)
n=133 participants at risk
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Canakinumab, Lyophilizate (LYO)
n=132 participants at risk
Participants 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.
|
Triamcinolone Acetonide
n=132 participants at risk
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
3/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
5.3%
7/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
0.76%
1/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
|
Vascular disorders
Hypertension
|
5.3%
7/133 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
4.5%
6/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
6.8%
9/132 • From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 \[NCT01356602\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place