Trial Outcomes & Findings for β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3) (NCT NCT01470989)
NCT ID: NCT01470989
Last Updated: 2021-07-09
Results Overview
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Results posted on
2021-07-09
Participant Flow
This study was conducted at 60 centers from 10-November-2011 (first participant first visit) to 22-May-2013 (last participant last visit).
A total of 456 participants were randomized in the core studies (CACZ885H2356 and CACZ885H2357) of which 335 participants entered the first extension (CACZ885H2356E2) study. Out of the 317 participants who completed the first extension studies, 272 participants entered the second extension studies(CACZ885H2357E2 ). Out of the 249 participants who completed the second extension studies 136 participants entered the third extension study(CACZ885H2357E3).
Participant milestones
| Measure |
Canakinumab 150 mg
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|
|
Overall Study
STARTED
|
227
|
229
|
|
Overall Study
Completed Core Study
|
208
|
208
|
|
Overall Study
Entered Extension 1 Study
|
174
|
161
|
|
Overall Study
Completed Extension 1 Study
|
165
|
152
|
|
Overall Study
Entered Extension 2 Study
|
141
|
131
|
|
Overall Study
Completed Extension 2 Study
|
132
|
117
|
|
Overall Study
Entered Extension 3
|
87
|
49
|
|
Overall Study
COMPLETED
|
79
|
43
|
|
Overall Study
NOT COMPLETED
|
148
|
186
|
Reasons for withdrawal
| Measure |
Canakinumab 150 mg
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|
|
Overall Study
Participants did not entered extension studies 1, 2 and 3
|
103
|
136
|
|
Overall Study
Adverse Event
|
2
|
5
|
|
Overall Study
Abnormal laboratory value
|
1
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
19
|
17
|
|
Overall Study
Lost to Follow-up
|
18
|
13
|
|
Overall Study
Administrative problems
|
2
|
4
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Protocol deviation
|
1
|
2
|
Baseline Characteristics
The mean value given here is from the CACZ885H2356E2 study.
Baseline characteristics by cohort
| Measure |
Canakinumab 150 mg
n=225 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
n=229 Participants
Participants received 40 mg Triamcinolone Acetonide intramuscular (IM) at randomization and upon new flare and re-treated with at least 1 dose of canakinumab.
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 12.10 • n=112 Participants • The mean value given here is from the CACZ885H2357E2 study.
|
52.6 years
STANDARD_DEVIATION 12.28 • n=114 Participants • The mean value given here is from the CACZ885H2357E2 study.
|
51.6 years
STANDARD_DEVIATION 12.21 • n=226 Participants • The mean value given here is from the CACZ885H2357E2 study.
|
|
Sex: Female, Male
Female
|
12 Participants
n=112 Participants • The value given here is from the CACZ885H2357E2 study.
|
9 Participants
n=114 Participants • The value given here is from the CACZ885H2357E2 study.
|
21 Participants
n=226 Participants • The value given here is from the CACZ885H2357E2 study.
|
|
Sex: Female, Male
Male
|
100 Participants
n=112 Participants • The value given here is from the CACZ885H2357E2 study.
|
105 Participants
n=114 Participants • The value given here is from the CACZ885H2357E2 study.
|
205 Participants
n=226 Participants • The value given here is from the CACZ885H2357E2 study.
|
|
Race/Ethnicity, Customized
Caucasian
|
74 Participants
n=112 Participants • The value given here is from the CACZ885H2357E2 study.
|
80 Participants
n=114 Participants • The value given here is from the CACZ885H2357E2 study.
|
154 Participants
n=226 Participants • The value given here is from the CACZ885H2357E2 study.
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=112 Participants • The value given here is from the CACZ885H2357E2 study.
|
9 Participants
n=114 Participants • The value given here is from the CACZ885H2357E2 study.
|
19 Participants
n=226 Participants • The value given here is from the CACZ885H2357E2 study.
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=113 Participants • The value given here is from the CACZ885H2356E2 study.
|
1 Participants
n=115 Participants • The value given here is from the CACZ885H2356E2 study.
|
2 Participants
n=228 Participants • The value given here is from the CACZ885H2356E2 study.
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=112 Participants • The value given here is from the CACZ885H2357E2 study.
|
1 Participants
n=114 Participants • The value given here is from the CACZ885H2357E2 study.
|
3 Participants
n=226 Participants • The value given here is from the CACZ885H2357E2 study.
|
|
Race/Ethnicity, Customized
Black
|
26 Participants
n=112 Participants • The value given here is from the CACZ885H2357E2 study.
|
24 Participants
n=114 Participants • The value given here is from the CACZ885H2357E2 study.
|
50 Participants
n=226 Participants • The value given here is from the CACZ885H2357E2 study.
|
PRIMARY outcome
Timeframe: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)Population: The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Outcome measures
| Measure |
Canakinumab 150 mg
n=225 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
n=229 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|
|
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Adverse Events
|
873 IR/100 patient-years
|
451 IR/100 patient-years
|
|
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Non Fatal SAEs
|
59 IR/100 patient-years
|
25 IR/100 patient-years
|
|
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Death
|
2 IR/100 patient-years
|
2 IR/100 patient-years
|
SECONDARY outcome
Timeframe: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)Population: Modified Analysis Set (MAS) consisted of all participants randomized in the core studies and received both treatments according to their exposure.
Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered.
Outcome measures
| Measure |
Canakinumab 150 mg
n=225 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
n=229 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|
|
Number of New Flares Per Participant
|
1.109 flares
Standard Deviation 1.608
|
2.459 flares
Standard Deviation 3.701
|
SECONDARY outcome
Timeframe: up to 7 days post-dosePopulation: Modified Analysis Set (MAS) consisted of all Full Analysis Set (FAS) participants. The FAS consisted of all enrolled participants who have received at least one dose of study medication. This outcome measure was assessed only in the subset of participants who had re-treatment with at least one dose of canakinumab.
Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild).
Outcome measures
| Measure |
Canakinumab 150 mg
n=127 Participants
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
n=78 Participants
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Baseline Flare
|
102 Participants
|
72 Participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Last New Flare
|
104 Participants
|
69 Participants
|
Adverse Events
Canakinumab 150 mg
Serious events: 35 serious events
Other events: 87 other events
Deaths: 2 deaths
Triamcinolone Acetonide 40 mg
Serious events: 23 serious events
Other events: 55 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Canakinumab 150 mg
n=225 participants at risk
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
n=229 participants at risk
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.89%
2/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.87%
2/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Angina unstable
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Arrhythmia
|
0.89%
2/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiac valve disease
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.87%
2/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Endocrine disorders
Goitre
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Eye disorders
Glaucoma
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal artery occlusion
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
General disorders
Cyst
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
General disorders
Device dislocation
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
General disorders
Hernia obstructive
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Abscess jaw
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Abscess limb
|
0.89%
2/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Investigations
Prostatic specific antigen increased
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Gout
|
0.89%
2/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.87%
2/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
3/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Convulsion
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.87%
2/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal colic
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal impairment
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Vesical fistula
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.44%
1/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.44%
1/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
0.00%
0/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Canakinumab 150 mg
n=225 participants at risk
Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes.
|
Triamcinolone Acetonide 40 mg
n=229 participants at risk
Participants received 40 mg intramuscular (IM) at randomization and upon new flare.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.6%
8/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
5.2%
12/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
18/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
3.1%
7/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
18/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
7.0%
16/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
20/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
1.3%
3/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.3%
12/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
2.6%
6/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
6.2%
14/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
4.4%
10/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
12.9%
29/225 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
9.2%
21/229 • Adverse Event were Collected From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place