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Trial record 16 of 990 for:    gout

A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

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ClinicalTrials.gov Identifier: NCT00819585
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : May 6, 2011
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Gout
Interventions Drug: Canakinumab
Drug: Colchicine
Drug: Allopurinol
Drug: Placebo Matching Canakinumab
Drug: Placebo Matching Colchicine
Enrollment 432
Recruitment Details  
Pre-assignment Details A total of 432 participants were enrolled in the study.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg Extension Study: Group A Extension Study: Group B Extension Study: Group C Extension Study: Group D
Hide Arm/Group Description Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks. Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85. Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study. Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study. Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study. Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.
Period Title: Core Study
Started 55 [1] 54 54 54 53 54 108 0 [2] 0 [2] 0 [2] 0 [2]
Received Study Medication 55 [3] 54 54 54 53 53 [4] 108 0 0 0 0
Completed 49 48 48 49 50 52 95 0 0 0 0
Not Completed 6 6 6 5 3 2 13 0 0 0 0
Reason Not Completed
Adverse Event             2             1             1             4             1             0             2             0             0             0             0
Abnormal Laboratory Value(s)             2             0             0             0             0             0             0             0             0             0             0
Unsatisfactory Therapeutic Effect             0             1             0             0             0             0             1             0             0             0             0
Subject No Longer Requires Study Drug             0             0             0             0             1             0             0             0             0             0             0
Subject Withdrew Consent             0             3             2             1             0             0             3             0             0             0             0
Lost to Follow-up             2             1             2             0             1             1             1             0             0             0             0
Administrative Problems             0             0             0             0             0             0             2             0             0             0             0
Death             0             0             0             0             0             0             1             0             0             0             0
Protocol Violation             0             0             1             0             0             1             3             0             0             0             0
[1]
Participants who started the core study are included in the randomized and full analysis sets.
[2]
There were no participants in this arm during the core study.
[3]
Participants who received study medication are included in the safety population.
[4]
One participant in this treatment arm was HIV+ve and did not receive any study medication.
Period Title: Extension Study
Started 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 75 181 25 60
Completed 0 0 0 0 0 0 0 75 173 24 58
Not Completed 0 0 0 0 0 0 0 0 8 1 2
Reason Not Completed
Abnormal Laboratory Value(s)             0             0             0             0             0             0             0             0             1             0             0
Subject Withdrew Consent             0             0             0             0             0             0             0             0             3             0             1
Lost to Follow-up             0             0             0             0             0             0             0             0             2             1             1
Death             0             0             0             0             0             0             0             0             2             0             0
[1]
There were no participants in this arm during the extension study.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg Total
Hide Arm/Group Description Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks. Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85. Total of all reporting groups
Overall Number of Baseline Participants 55 54 54 54 53 53 108 431
Hide Baseline Analysis Population Description
The Baseline Characteristics of the reporting groups are based on the safety set, which included all participants who received study medication. Of the 432 participants enrolled in the core study, 1 participant did not receive any study medication and was not included in the safety set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 54 participants 54 participants 54 participants 53 participants 53 participants 108 participants 431 participants
50.7  (9.72) 54.4  (12.18) 51.3  (12.41) 52.6  (10.78) 52.4  (11.30) 52.8  (10.38) 52.4  (10.69) 52.4  (11.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 54 participants 54 participants 53 participants 53 participants 108 participants 431 participants
Female
0
   0.0%
3
   5.6%
6
  11.1%
4
   7.4%
2
   3.8%
4
   7.5%
7
   6.5%
26
   6.0%
Male
55
 100.0%
51
  94.4%
48
  88.9%
50
  92.6%
51
  96.2%
49
  92.5%
101
  93.5%
405
  94.0%
1.Primary Outcome
Title Core Study: Mean Number of Gout Flares Per Participant
Hide Description A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Time Frame Baseline of the core study to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg
Hide Arm/Group Description:
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Overall Number of Participants Analyzed 55 54 54 54 53 54 108
Mean (Standard Deviation)
Unit of Measure: Gout flares
0.5  (1.03) 0.4  (1.82) 0.2  (0.53) 0.4  (1.35) 0.2  (0.53) 0.7  (2.24) 0.7  (1.00)
2.Secondary Outcome
Title Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
Hide Description [Not Specified]
Time Frame up to 16 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab 25 mg Canakinumab 50 mg Canakinumab 100 mg Canakinumab 200 mg Canakinumab 300 mg Canakinumab q4wk
Hide Arm/Group Description:
Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
Overall Number of Participants Analyzed 55 54 54 54 53 54
Least Squares Mean (Standard Error)
Unit of Measure: gout flares per patient
0.48  (0.204) 0.43  (0.207) 0.22  (0.209) 0.38  (0.205) 0.21  (0.209) 0.68  (0.209)
3.Secondary Outcome
Title Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
Time Frame Baseline of the core study to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg
Hide Arm/Group Description:
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Overall Number of Participants Analyzed 55 54 54 54 53 54 108
Measure Type: Number
Unit of Measure: Percentage of participants
27.3 16.7 14.8 18.5 15.1 16.7 44.4
4.Secondary Outcome
Title Core Study: Percentage of Participants With Gout Flare at Different Time Points
Hide Description A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Time Frame Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg
Hide Arm/Group Description:
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Overall Number of Participants Analyzed 55 54 54 54 53 54 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2 days post-dose
5.5
(1.79 to 15.96)
3.7
(0.94 to 14.01)
3.7
(0.94 to 14.01)
3.7
(0.94 to 14.01)
0.0
(0.0 to 0.0)
3.8
(0.96 to 14.26)
5.6
(2.53 to 11.95)
4 days post-dose
10.9
(5.05 to 22.68)
3.7
(0.94 to 14.01)
3.7
(0.94 to 14.01)
3.7
(0.94 to 14.01)
5.7
(1.86 to 16.53)
3.8
(0.96 to 14.26)
10.2
(5.77 to 17.64)
6 days post-dose
12.7
(6.28 to 24.85)
5.6
(1.83 to 16.24)
3.7
(0.94 to 14.01)
7.4
(2.85 to 18.54)
5.7
(1.86 to 16.53)
3.8
(0.96 to 23.56)
11.1
(6.47 to 18.74)
2 weeks post-dose
14.5
(7.55 to 26.99)
7.4
(2.85 to 18.54)
7.4
(2.85 to 18.54)
11.1
(5.15 to 23.07)
7.5
(2.90 to 18.87)
11.3
(5.25 to 23.48)
16.7
(10.85 to 25.14)
4 weeks post-dose
14.5
(7.55 to 26.99)
9.3
(3.96 to 20.83)
7.4
(2.85 to 18.54)
13.0
(6.40 to 25.28)
11.4
(5.27 to 23.56)
15.1
(7.85 to 27.92)
25.1
(17.93 to 34.38)
6 weeks post-dose
16.5
(8.96 to 29.39)
11.1
(5.15 to 23.07)
9.3
(3.98 to 20.91)
13.0
(6.40 to 25.28)
11.4
(5.27 to 23.56)
27.92
(7.85 to 27.92)
32.6
(24.58 to 42.30)
10 weeks post-dose
22.5
(13.43 to 36.26)
13.1
(6.46 to 25.52)
11.2
(5.19 to 23.22)
16.8
(9.11 to 29.79)
11.4
(5.27 to 23.56)
17.0
(9.22 to 30.09)
37.5
(29.06 to 47.43)
16 weeks post-dose
28.7
(18.34 to 43.10)
17.3
(9.37 to 30.66)
15.1
(7.82 to 27.87)
18.8
(10.59 to 32.19)
15.3
(7.96 to 28.29)
17.0
(9.22 to 30.09)
45.8
(36.76 to 55.87)
5.Secondary Outcome
Title Core Study: Participant’s Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
Hide Description Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Time Frame Baseline of the core study to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg
Hide Arm/Group Description:
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Overall Number of Participants Analyzed 55 54 54 54 53 54 108
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1 (n=15, 9, 8, 9, 8, 9, 48) 41.1  (31.01) 44.6  (15.82) 56.3  (26.72) 53.0  (27.99) 52.2  (19.40) 66.1  (15.07) 53.1  (24.18)
Day 2 (n=12, 7, 6, 5, 5, 7, 44) 44.8  (30.06) 40.1  (26.73) 46.2  (35.11) 19.8  (32.05) 43.1  (17.62) 59.3  (23.53) 42.8  (24.37)
Day 3 (n=10, 4, 4, 4, 4, 5, 38) 31.5  (20.82) 49.5  (18.48) 49.5  (25.29) 56.7  (40.91) 26.3  (14.64) 58.0  (27.59) 38.1  (23.37)
Day 4 (n=7, 3, 2, 3, 3, 6, 31) 31.8  (16.77) 46.3  (10.60) 16.5  (23.33) 63.5  (33.0) 11.0  (11.0) 49.4  (27.73) 30.5  (26.68)
Day 5 (n=7, 2, 1, 3, 2, 4, 22) 19.3  (14.79) 48.0  (5.66) 0.0  (0.0) 54.8  (43.38) 13.0  (0.0) 41.4  (33.63) 31.8  (29.91)
Day 6 (n=6, 1, 1, 2, 1, 3, 18) 19.6  (14.14) 44.0  (0.0) 0.0  (0.0) 57.5  (60.10) 12.0  (0.0) 43.5  (24.38) 33.7  (26.66)
Day 7 (n=6, 0, 1, 2, 1, 2, 16) 20.9  (16.91) NA [1]   (NA) 0.0  (0.0) 35.0  (49.50) 0.0  (0.0) 52.0  (11.31) 33.0  (22.16)
[1]
No data is available
6.Secondary Outcome
Title Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
Hide Description Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Time Frame Baseline of the core study to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg
Hide Arm/Group Description:
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Overall Number of Participants Analyzed 55 54 54 54 53 54 108
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1 (n=15, 8, 8, 9, 8, 9, 48) 2.8  (0.88) 3.1  (0.65) 3.5  (1.20) 3.2  (0.92) 3.1  (0.35) 3.8  (0.60) 3.2  (0.77)
Day 2 (n=12, 6, 6, 5, 5, 7, 44) 2.9  (0.92) 2.6  (1.02) 3.3  (1.51) 2.2  (1.10) 2.9  (0.74) 3.5  (1.05) 3.0  (0.86)
Day 3 (n=10, 4, 4, 4, 4, 6, 38) 2.4  (0.73) 3.1  (0.63) 2.3  (0.96) 3.0  (1.15) 2.3  (0.50) 3.4  (1.07) 2.7  (0.76)
Day 4 (n=7, 3, 2, 3, 3, 7, 31) 2.6  (0.57) 2.7  (0.58) 1.5  (0.71) 3.0  (1.00) 1.7  (0.58) 3.2  (1.08) 2.4  (0.90)
Day 5 (n=7, 2, 1, 3, 2, 4, 22) 2.2  (0.69) 2.5  (0.71) 1.0  (0) 3.2  (1.76) 1.5  (0.71) 2.7  (1.28) 2.6  (0.95)
Day 6 (n=6, 1, 1, 2, 2, 3, 18) 2.4  (0.49) 3.0  (0.0) 1.0  (0.0) 3.5  (2.12) 1.5  (0.71) 2.9  (0.84) 2.5  (1.05)
Day 7 (n=6, 0, 1, 2, 1, 2, 16) 2.4  (0.49) NA [1]   (NA) 1.0  (0.0) 2.5  (2.12) 1.0  (0.0) 3.3  (0.47) 2.4  (0.81)
[1]
No participants analyzed.
7.Secondary Outcome
Title Core Study: Physician’s Global Assessment of Response to Therapy on a 5-point Likert Scale
Hide Description The study physician made a global assessment of the participant’s response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category ‘Not assessed’ includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Time Frame Days 15, 29, 57, 85, 113, and 141 of the core study
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Hide Analysis Population Description
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Arm/Group Title Core Study: Canakinumab 25 mg Core Study: Canakinumab 50 mg Core Study: Canakinumab 100 mg Core Study: Canakinumab 200 mg Core Study: Canakinumab 300 mg Core Study: Canakinumab q4wk Core Study: Colchicine 0.5 mg
Hide Arm/Group Description:
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Overall Number of Participants Analyzed 55 54 54 54 53 54 108
Measure Type: Number
Unit of Measure: Participants
Day 15: Very good 19 23 24 23 27 25 40
Day 15 - Good 28 24 23 26 21 20 42
Day 15 - Fair 5 4 3 4 0 3 16
Day 15 - Poor 0 0 2 0 3 4 6
Day 15 - Very poor 0 1 0 0 0 0 2
Day 15 - Not assessed 3 1 1 1 1 2 2
Day 29: Very good 26 24 25 24 27 27 39
Day 29- Good 23 22 22 26 23 22 42
Day 29 - Fair 2 4 5 3 2 2 19
Day 29 - Poor 0 0 1 0 0 2 2
Day 29 - Very poor 0 1 0 0 0 0 1
Day 29 - Not assessed 0 3 0 0 0 1 3
Day 57: Very good 25 27 28 27 30 28 46
Day 57- Good 21 20 16 21 18 20 43
Day 57 - Fair 5 3 6 4 4 3 9
Day 57 - Poor 0 0 2 0 0 2 3
Day 57 - Very poor 0 1 0 0 0 0 1
Day 57 - Not assessed 0 2 1 0 0 1 4
Day 85: Very good 27 31 32 32 31 29 43
Day 85 - Good 20 17 15 16 17 17 41
Day 85 - Fair 3 2 5 4 2 3 12
Day 85 - - Poor 0 0 1 0 1 2 2
Day 85 - Very poor 0 0 0 0 0 1 0
Day 85 - Not assessed 1 2 0 0 1 1 5
Day 113 : Very good 24 29 30 26 29 32 50
Day 113 - Good 18 18 18 20 20 15 36
Day 113 - Fair 5 3 2 3 1 3 7
Day 113 - Poor 2 0 1 1 1 2 2
Day 113 - Very poor 0 0 0 0 0 0 1
Day 113 - Not Assessed 0 2 0 0 0 2 8
Day 141 : Very good 26 25 24 31 32 32 41
Day 141 - Good 16 20 19 12 14 14 36
Day 141 - Fair 6 2 3 6 2 3 16
Day 141 - Poor 1 1 3 0 0 2 2
Day 141 - Very poor 0 0 0 1 1 1 0
Day 141 - Not Assessed 0 3 1 0 1 1 5
8.Secondary Outcome
Title Extension Study: Participant’s Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare
Hide Description Participant’s rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose
Time Frame Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Arm/Group Title Extension Study: Group A Extension Study: Group C
Hide Arm/Group Description:
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Overall Number of Participants Analyzed 65 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pre-dose (n=65, 19) 61.3  (27.13) 71.8  (20.86)
24 hours (n=65, 18) 23.8  (23.32) 29.0  (22.85)
3 days (n=54, 15) 12.4  (16.82) 6.8  (9.03)
4 days (n=54, 15) 8.8  (14.32) 2.7  (5.06)
5-7 days (n=52, 13) 8.1  (15.86) 2.1  (4.70)
9.Secondary Outcome
Title Extension Study: Participant’s Global Assessment of Response to Treatment on a 5-point Likert Scale
Hide Description Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.
Time Frame Baseline of the extension study until the end of the study (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Arm/Group Title Extension Study: Group A Extension Study: Group C
Hide Arm/Group Description:
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Overall Number of Participants Analyzed 63 21
Measure Type: Number
Unit of Measure: Participants
Gout Flare 1: Excellent (63, 21) 40 7
Gout Flare 1: Good (63, 21) 17 14
Gout Flare 1: Acceptable (63, 21) 5 0
Gout Flare 1: Slight (63, 21) 1 0
Gout Flare 1: Poor (63, 21) 0 0
Gout Flare 2: Excellent (11, 5) 4 4
Gout Flare 2: Good (11, 5) 6 1
Gout Flare 2: Acceptable (11, 5) 1 0
Gout Flare 2: Slight (11, 5) 0 0
Gout Flare 2: Poor (11, 5) 0 0
Gout Flare 3: Excellent (3, 1) 2 0
Gout Flare 3: Good (3, 1) 1 1
Gout Flare 3: Acceptable (3, 1) 0 0
Gout Flare 3: Slight (3, 1) 0 0
Gout Flare 3: Poor (3, 1) 0 0
10.Secondary Outcome
Title Extension Study: Physician’s Global Assessment of Response to Treatment on a 5-point Likert Scale
Hide Description The study physician made a global assessment of the participant’s response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category ‘Not assessed’ includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Time Frame Baseline of the extension study until the end of the study (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Arm/Group Title Extension Study: Group A Extension Study: Group C
Hide Arm/Group Description:
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Overall Number of Participants Analyzed 69 23
Measure Type: Number
Unit of Measure: Participants
Gout Flare 1: Very Good (69, 23) 37 13
Gout Flare 1: Good (69, 23) 28 10
Gout Flare 1: Fair (69, 23) 2 0
Gout Flare 1: Poor (69, 23) 2 0
Gout Flare 1: Very Poor (69, 23) 0 0
Gout Flare 2: Very Good (12, 5) 5 3
Gout Flare 2: Good (12, 5) 7 2
Gout Flare 2: Fair (12, 5) 0 0
Gout Flare 2: Poor (12, 5) 0 0
Gout Flare 2: Very Poor (12, 5) 0 0
Gout Flare 3: Very Good (3, 1) 1 0
Gout Flare 3: Good (3, 1) 2 1
Gout Flare 3: Fair (3, 1) 0 0
Gout Flare 3: Poor (3, 1) 0 0
Gout Flare 3: Very Poor (3, 1) 0 0
11.Secondary Outcome
Title Extension Study: Physician’s Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare
Hide Description Tenderness was rated on a 0-3 point scale: 0=“no pain”, 1=patient states that “there is pain”, 2=patient states “there is pain and winces”, and 3=patient states “there is pain, winces and withdraws” on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=“no swelling”, 1=“palpable”, 2=“visible”, and 3=bulging beyond the joint margins”. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
Time Frame Baseline of the extension study until the end of the study (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Arm/Group Title Extension Study: Group A Extension Study: Group C
Hide Arm/Group Description:
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Overall Number of Participants Analyzed 69 24
Measure Type: Number
Unit of Measure: Participants
Tenderness Flare Visit: No pain 2 0
Tenderness Flare Visit: Pain 27 2
Tenderness Flare Visit: Pain and winces 23 10
Tenderness Flare Visit: Pain, winces and withdraws 17 12
Tenderness Control Visit: No pain 60 21
Tenderness Control Visit: Pain 8 3
Tenderness Control Visit: Pain and winces 1 0
Tenderness Control Visit: Pain, winces and withdra 0 0
Joint Swelling Flare Visit: No swelling 5 0
Joint Swelling Flare Visit: Palpable 20 2
Joint Swelling Flare Visit: Visible 31 17
Joint Swelling Flare Visit: Bulging beyond joint 13 5
Joint Swelling Control Visit: No swelling 61 22
Joint Swelling Control Visit: Palpable 6 2
Joint Swelling Control Visit: Visible 2 0
Joint Swelling Control Visit: Bulging beyond joint 0 0
Erythema Flare Visit: Absent 21 4
Erythema Flare Visit: Present 44 20
Erythema Flare Visit: Not assessed 0 0
Erythema Control Visit: Absent 66 24
Erythema Control Visit: Present 3 0
Erythema Control Visit: Not assessed 0 0
12.Secondary Outcome
Title Extension Study: Amount of Rescue Medication Taken
Hide Description The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Time Frame Baseline of the extension study until the end of the study (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Arm/Group Title Extension Study: Group A Extension Study: Group C
Hide Arm/Group Description:
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Overall Number of Participants Analyzed 68 24
Mean (Standard Deviation)
Unit of Measure: mg
Gout Flare 1: Naproxen (n=68, 24) 1086.8  (1592.72) 954.6  (1130.19)
Gout Flare 1: Prednisolone (68, 24) 4.6  (20.84) 4.2  (20.41)
Gout Flare 2: Naproxen (n=12, 5) 650.0  (642.79) 200.0  (447.21)
Gout Flare 2: Prednisolone (12, 5) 1.3  (3.11) 0.0  (0.00)
Gout Flare 3: Naproxen (n=4, 1) 250.0  (500.00) 0.0  (0.00)
Gout Flare 3: Prednisolone (4, 1) 0.0  (0.00) 0.0  (0.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Core Study: ACZ 25 mg Core Study: ACZ 50 mg Core Study: ACZ 100 mg Core Study: ACZ 200 mg Core Study: ACZ 300 mg Core Study: ACZ Q4wk mg Core Study: Colch 0.5 mg Extension Study: Group A Extension Study: Group B Extension Study: Group C Extension Study: Group D
Hide Arm/Group Description Core study: ACZ 25 mg Core study: ACZ 50 mg Core study: ACZ 100 mg Core study: ACZ 200 mg Core study: ACZ 300 mg Core study: ACZ Q4wk mg Core study: Colch 0.5 mg Extension study: Group A Extension study: Group B Extension study: Group C Extension study: Group D
All-Cause Mortality
Core Study: ACZ 25 mg Core Study: ACZ 50 mg Core Study: ACZ 100 mg Core Study: ACZ 200 mg Core Study: ACZ 300 mg Core Study: ACZ Q4wk mg Core Study: Colch 0.5 mg Extension Study: Group A Extension Study: Group B Extension Study: Group C Extension Study: Group D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Core Study: ACZ 25 mg Core Study: ACZ 50 mg Core Study: ACZ 100 mg Core Study: ACZ 200 mg Core Study: ACZ 300 mg Core Study: ACZ Q4wk mg Core Study: Colch 0.5 mg Extension Study: Group A Extension Study: Group B Extension Study: Group C Extension Study: Group D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/55 (3.64%)   2/54 (3.70%)   3/54 (5.56%)   3/54 (5.56%)   3/53 (5.66%)   1/53 (1.89%)   6/108 (5.56%)   4/75 (5.33%)   6/181 (3.31%)   0/25 (0.00%)   1/60 (1.67%) 
Cardiac disorders                       
Acute myocardial infarction  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Angina pectoris  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Myocardial fibrosis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Myocardial infarction  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Gastrointestinal disorders                       
Abdominal hernia  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Abdominal pain  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Colitis ulcerative  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/53 (1.89%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Gastritis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Haemorrhoidal haemorrhage  1  0/55 (0.00%)  1/54 (1.85%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Inguinal hernia  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  1/75 (1.33%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Umbilical hernia  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Hepatobiliary disorders                       
Cholelithiasis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Infections and infestations                       
Diverticulitis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  1/75 (1.33%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Ear infection  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Erysipelas  1  1/55 (1.82%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Gangrene  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Pneumonia  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Sepsis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Tonsillitis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Injury, poisoning and procedural complications                       
Femur fracture  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Gun shot wound  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Hand fracture  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Heat exhaustion  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Incisional hernia  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Ligament rupture  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/53 (1.89%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Meniscus lesion  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  1/60 (1.67%) 
Radius fracture  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Tibia fracture  1  1/55 (1.82%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Ulna fracture  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Gouty tophus  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  1/75 (1.33%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Osteoarthritis  1  0/55 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Tendonitis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Prostate cancer  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/53 (1.89%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Renal cancer  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Nervous system disorders                       
Stupor  1  0/55 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Transient ischaemic attack  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Renal and urinary disorders                       
Haematuria  1  0/55 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Nephrolithiasis  1  0/55 (0.00%)  1/54 (1.85%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Nephrotic syndrome  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Renal failure  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Reproductive system and breast disorders                       
Prostatitis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  1/75 (1.33%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Vascular disorders                       
Deep vein thrombosis  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/108 (0.00%)  1/75 (1.33%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Core Study: ACZ 25 mg Core Study: ACZ 50 mg Core Study: ACZ 100 mg Core Study: ACZ 200 mg Core Study: ACZ 300 mg Core Study: ACZ Q4wk mg Core Study: Colch 0.5 mg Extension Study: Group A Extension Study: Group B Extension Study: Group C Extension Study: Group D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/55 (38.18%)   15/54 (27.78%)   14/54 (25.93%)   14/54 (25.93%)   15/53 (28.30%)   14/53 (26.42%)   21/108 (19.44%)   21/75 (28.00%)   19/181 (10.50%)   6/25 (24.00%)   4/60 (6.67%) 
Gastrointestinal disorders                       
Diarrhoea  1  3/55 (5.45%)  1/54 (1.85%)  2/54 (3.70%)  3/54 (5.56%)  1/53 (1.89%)  0/53 (0.00%)  2/108 (1.85%)  2/75 (2.67%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Nausea  1  2/55 (3.64%)  1/54 (1.85%)  3/54 (5.56%)  0/54 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  1/108 (0.93%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Infections and infestations                       
Nasopharyngitis  1  5/55 (9.09%)  2/54 (3.70%)  2/54 (3.70%)  0/54 (0.00%)  0/53 (0.00%)  3/53 (5.66%)  1/108 (0.93%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  2/60 (3.33%) 
Upper respiratory tract infection  1  2/55 (3.64%)  1/54 (1.85%)  2/54 (3.70%)  3/54 (5.56%)  1/53 (1.89%)  3/53 (5.66%)  4/108 (3.70%)  5/75 (6.67%)  4/181 (2.21%)  1/25 (4.00%)  0/60 (0.00%) 
Investigations                       
Alanine aminotransferase increased  1  3/55 (5.45%)  1/54 (1.85%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Aspartate aminotransferase increased  1  3/55 (5.45%)  1/54 (1.85%)  0/54 (0.00%)  1/54 (1.85%)  0/53 (0.00%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  1/181 (0.55%)  0/25 (0.00%)  0/60 (0.00%) 
Metabolism and nutrition disorders                       
Hypertriglyceridaemia  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  2/54 (3.70%)  1/53 (1.89%)  0/53 (0.00%)  0/108 (0.00%)  0/75 (0.00%)  1/181 (0.55%)  2/25 (8.00%)  0/60 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Arthralgia  1  4/55 (7.27%)  5/54 (9.26%)  4/54 (7.41%)  2/54 (3.70%)  3/53 (5.66%)  2/53 (3.77%)  3/108 (2.78%)  4/75 (5.33%)  6/181 (3.31%)  0/25 (0.00%)  1/60 (1.67%) 
Back pain  1  3/55 (5.45%)  3/54 (5.56%)  1/54 (1.85%)  3/54 (5.56%)  0/53 (0.00%)  0/53 (0.00%)  4/108 (3.70%)  1/75 (1.33%)  2/181 (1.10%)  0/25 (0.00%)  0/60 (0.00%) 
Nervous system disorders                       
Headache  1  4/55 (7.27%)  3/54 (5.56%)  1/54 (1.85%)  2/54 (3.70%)  6/53 (11.32%)  3/53 (5.66%)  6/108 (5.56%)  3/75 (4.00%)  2/181 (1.10%)  1/25 (4.00%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Cough  1  0/55 (0.00%)  1/54 (1.85%)  2/54 (3.70%)  2/54 (3.70%)  1/53 (1.89%)  0/53 (0.00%)  0/108 (0.00%)  4/75 (5.33%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Sinus congestion  1  0/55 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  0/54 (0.00%)  3/53 (5.66%)  0/53 (0.00%)  1/108 (0.93%)  0/75 (0.00%)  0/181 (0.00%)  0/25 (0.00%)  0/60 (0.00%) 
Skin and subcutaneous tissue disorders                       
Rash  1  1/55 (1.82%)  1/54 (1.85%)  0/54 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  3/53 (5.66%)  1/108 (0.93%)  1/75 (1.33%)  0/181 (0.00%)  0/25 (0.00%)  1/60 (1.67%) 
Vascular disorders                       
Hypertension  1  6/55 (10.91%)  2/54 (3.70%)  2/54 (3.70%)  5/54 (9.26%)  4/53 (7.55%)  2/53 (3.77%)  1/108 (0.93%)  6/75 (8.00%)  3/181 (1.66%)  2/25 (8.00%)  0/60 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00819585     History of Changes
Other Study ID Numbers: CACZ885H2251
EudraCT : 2008-005876-28
First Submitted: January 8, 2009
First Posted: January 9, 2009
Results First Submitted: February 28, 2011
Results First Posted: May 6, 2011
Last Update Posted: July 17, 2018