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Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study (β-RELIEVED)

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ClinicalTrials.gov Identifier: NCT01029652
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : November 18, 2011
Last Update Posted : January 30, 2014
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: Treatment
Condition Acute Gout
Interventions Drug: Canakinumab 150 mg
Drug: Triamcinolone acetonide 40 mg
Drug: Placebo to canakinumab
Drug: Placebo to triamcinolone acetonide
Enrollment 230
Recruitment Details  
Pre-assignment Details Two patients randomized to canakinumab did not receive any study medication and were discontinued from the core study on the day of randomization, with the reason for discontinuation listed as Administrative Problems.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study .

Period Title: Core Study (0-12 Weeks)
Started 115 115
Full Analysis Set (FAS), Safety Set 113 115
Completed 109 105
Not Completed 6 10
Reason Not Completed
Unsatisfactory therapeutic effect             0             4
Patient Withdrew Consent             1             3
Lost to Follow-up             3             1
Administrative problems             2             1
Death             0             1
Period Title: Extension Study 1 (12-24 Weeks)
Started 90 85
Completed 87 80
Not Completed 3 5
Reason Not Completed
Unsatisfactory therapeutic effect             0             1
Lost to Follow-up             2             3
Protocol Deviation             1             0
Withdrawal by Subject             0             1
Period Title: Extension Study 2 (25-72 Weeks)
Started 69 66
Re-treated With or Switch to Canakinumab 69 [1] 39 [2]
Completed 68 63
Not Completed 1 3
Reason Not Completed
Death             1             1
Unsatisfactory therapeutic effect             0             1
Withdrawal by Subject             0             1
[1]
Includes patients re-treated with canakinumab over 72 weeks study duration overall
[2]
Includes patients switched to canakinumab from Week 25 - Week 72
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg Total
Hide Arm/Group Description Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Total of all reporting groups
Overall Number of Baseline Participants 113 115 228
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 115 participants 228 participants
54  (11.18) 54.6  (10.71) 54.3  (10.93)
[1]
Measure Description: Two patients randomized to canakinumab were not included in the data set (safety set) used to calculate demographic data as they did not receive any study medication and were discontinued from the study on the day of randomization.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 115 participants 228 participants
< 65 years 92 92 184
≥ 65 - 74 years 16 21 37
≥ 75 years 5 2 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 115 participants 228 participants
Female
12
  10.6%
7
   6.1%
19
   8.3%
Male
101
  89.4%
108
  93.9%
209
  91.7%
1.Primary Outcome
Title Time to First New Flare
Hide Description

Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

· Increasing/renewed gout pain in an affected joint before flare has resolved completely.

Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to first new flare could not be estimated because <50% of patients had a new flare during the time period.
2.Primary Outcome
Title Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
Hide Description Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
Time Frame 72 hours post-dose (randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 112 111
Least Squares Mean (Standard Error)
Unit of Measure: mm
28.1  (2.42) 39.5  (2.44)
3.Primary Outcome
Title Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)
Hide Description This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time Frame 24 weeks overall
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Participants
Adverse Event 71 56
Death 0 1
Serious Adverse Event 11 6
4.Primary Outcome
Title Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)
Hide Description This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time Frame 72 weeks overall
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.
Arm/Group Title All Randomized to Canakinumab Randomized to Canakinumab :Before Re-treated With Canakinumab Randomized to Canakinumab :After Re-treated With Canakinumab Randomized to Triamcinolone Acetonide (Triam) Randomized to Triam: Before Switched to Canakinumab Randomized to Triam: After Switched to Canakinumab
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab

All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
Overall Number of Participants Analyzed 113 69 69 115 39 39
Measure Type: Number
Unit of Measure: Participants
Adverse Event 76 41 38 60 20 19
Death 1 0 1 2 0 0
Serious Adverse Event 19 6 8 11 2 0
5.Secondary Outcome
Title Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
Hide Description The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.
Time Frame From baseline to 7 days post dose (randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 112 111
Median (95% Confidence Interval)
Unit of Measure: Hours
48.0
(24.0 to 60.0)
72.0
(48.0 to 96.0)
6.Secondary Outcome
Title Time to Complete Resolution of Pain
Hide Description Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.
Time Frame 7 days post-dose (randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Median (95% Confidence Interval)
Unit of Measure: Hours
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to complete resolution could not be estimated because <50% of patients had a complete resolution during the time period.
7.Secondary Outcome
Title Percentage of Participants With Complete Resolution of Pain
Hide Description Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval.
Time Frame 7 days post-dose (randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
34.5
(26.6 to 44.1)
31.3
(23.7 to 40.6)
8.Secondary Outcome
Title Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks
Hide Description

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

· Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Percentage of participants
18.6 34.8
9.Secondary Outcome
Title Mean Number of New Gout Flares Per Patient
Hide Description

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

· Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Mean (Standard Deviation)
Unit of Measure: New flares/patient/12 weeks
0.21  (0.472) 0.53  (0.892)
10.Secondary Outcome
Title SF36 Physical Function Score at Week 12
Hide Description The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participant observations at Week 12 were included in the analysis.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 96 92
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
71.76  (2.688) 71.48  (2.745)
11.Secondary Outcome
Title Time to First New Flare
Hide Description

Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

· Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
119 [2] 
(94 to NA)
[1]
The median time to first new flare could not be estimated because <50% of patients had a new flare during the time period.
[2]
The upper limit was not estimable in the study as it is longer than the duration of the study (24 weeks).
12.Secondary Outcome
Title Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study
Hide Description

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

· Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Mean (Standard Deviation)
Unit of Measure: New flares/patient/24 weeks
0.40  (0.634) 0.87  (1.104)
13.Secondary Outcome
Title Time to First Intake of Rescue Medication After the Last Post Baseline Flare.
Hide Description The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.
Time Frame 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations 72 hours post-dose for the last post-baseline flare during 24 weeks were included in analysis.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 35 43
Median (95% Confidence Interval)
Unit of Measure: Hours
NA [1] 
(12 to NA)
NA [1] 
(11 to NA)
[1]
The data were not estimable as <50% patients took rescue medication.
14.Secondary Outcome
Title Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension
Hide Description Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
Time Frame 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was applied to impute post dose measurements.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 35 41
Least Squares Mean (Standard Error)
Unit of Measure: mm
34.6  (4.35) 44.9  (4.01)
15.Secondary Outcome
Title Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)
Hide Description Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).
Time Frame Last post-baseline flare (during 24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with baseline and last post-baseline observations were included in this analysis.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 35 43
Measure Type: Number
Unit of Measure: Percentage of participants
None 0.0 0.0
Mild 0.0 2.3
Moderate 14.3 16.3
Severe 77.1 60.5
Extreme 8.6 20.9
16.Secondary Outcome
Title Amount of Rescue Medication Taken
Hide Description

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

  • Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
  • If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.
Time Frame 7 days last post-baseline flare (during 24 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations at 7 days last post-baseline flare were included in this analysis.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 35 43
Mean (Standard Deviation)
Unit of Measure: mg
Acetaminophen 1931.4  (3266.12) 2058.1  (3331.33)
Codeine 7.7  (25.56) 46.0  (118.26)
Prednisolone/Prednisone 4.1  (17.34) 21.6  (47.42)
17.Secondary Outcome
Title Percentage of Participants Who Took Rescue Medication
Hide Description Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.
Time Frame during 12 weeks core, 24 weeks overall
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. "12 weeks:Core" consisted of patients taking rescue medication during baseline flare of Core study and "24 weeks:Overall" consisted of patients who took rescue medication during last post-baseline flare during 24 weeks.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Percentage of participants
12 weeks :Core (N=113, 115) 31.0 52.2
24 weeks: Overall (N=35, 43) 48.6 44.2
18.Secondary Outcome
Title High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall
Hide Description High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.
Time Frame 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. Patients with baseline flare and data at 72 hours post-dose in core and patients with a new flare and data at 72 hours post-dose for the last post-baseline flare (during 24 weeks overall) were included in this analysis.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/L
hsCRP : Core(n= 109, 107)
4.50
(3.96 to 5.12)
7.08
(6.22 to 8.07)
SAA protein : Core (n=105, 106)
6.77
(5.57 to 8.21)
17.00
(14.01 to 20.62)
hsCRP : 24 weeks(n= 31, 32)
5.18
(3.79 to 7.09)
7.18
(5.27 to 9.77)
SAA protein : 24 weeks (n=28, 33)
11.43
(7.76 to 16.84)
21.11
(14.78 to 30.16)
19.Secondary Outcome
Title Physician’s Global Assessment of Response to Treatment
Hide Description The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s assessments (pain intensity [Visual Analog Scale and Likert scale] and patient’s global assessment of response to treatment).
Time Frame 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Percentage of participants
Very good (Core) [N=113,110] 16.8 15.5
Good (Core) [N=113, 110] 47.8 30.0
Fair (Core) [N= 113, 110] 26.5 32.7
Poor (Core) [N= 113, 110] 7.1 14.5
Very poor (Core) [N=113, 110] 1.8 7.3
Very Good ( 24 weeks) [N=87, 79] 43.7 27.8
Good (24 weeks) [N=87, 79] 50.6 50.6
Fair (24 weeks) [N=87, 79] 5.7 17.7
Poor (24 weeks) [N=87, 79] 0.0 3.8
Very Poor (24 weeks) [N=87, 79] 0.0 0.0
20.Secondary Outcome
Title Patient’s Global Assessment of Response to Treatment
Hide Description Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured.
Time Frame 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Percentage of participants
Excellent (Core) [N=113, 111] 12.4 12.6
Good (Core) [N=113, 111] 38.9 28.8
Acceptable (Core) [N=113, 111] 37.2 30.6
Slight (Core) [N=113, 111] 8.8 12.6
Poor (Core) [N=113, 111] 2.7 15.3
Excellent (24 weeks) [N=87, 78] 31 17.9
Good (24 weeks) [N=87, 78] 46 44.9
Acceptable (24 weeks) [N=87, 78] 20.7 25.6
Slight (24 weeks) [N=87, 78] 1.1 9.0
Poor (24 weeks) [N=87, 78] 1.1 2.6
21.Secondary Outcome
Title Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
Hide Description The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported.
Time Frame 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Percentage of participants
TENDERNESS - No pain (Core) [N=113, 110] 33.6 26.4
Pain (Core) [N=113, 110] 56.6 51.8
Pain and winces (Core) [N=113, 110] 8.0 17.3
Pain,winces,withdraws (Core) [N=113,110] 1.8 4.5
SWELLING - No swelling (Core) [N=113, 110] 38.1 30.0
Palpable (Core) [N=113, 110] 38.9 35.5
Visible (Core) [N=113, 110] 21.2 29.1
Bulging beyond joint margin (Core) [N=113, 110] 1.8 5.5
ERYTHEMA - Absent (Core) [N=112, 109] 78.6 65.1
Present (Core) [N=112, 109] 21.4 34.9
TENDERNESS - No pain (24 weeks) [N=87, 80] 82.8 85.0
Pain (24 weeks) [N=87, 80] 17.2 13.8
Pain and winces (24 weeks) [N=87, 80] 0.0 1.3
Pain,winces,withdraws (24 weeks) [N=87, 80] 0.0 0.0
SWELLING - No swelling (24 weeks) [N=87, 80] 88.5 93.8
Palpable (24 weeks) [N=87, 80] 8.0 5.0
Visible (24 weeks) [N=87, 80] 3.4 1.3
Bulging beyond joint margin (24 week)[N=87,80] 0.0 0.0
ERYTHEMA - Absent (24 weeks) [N=87, 80] 98.9 100
Present (24 weeks) [N=87, 80] 1.1 0.0
22.Secondary Outcome
Title Physician’s Assessment of Range of Motion of the Most Affected Joint
Hide Description The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of patients in each category is reported.
Time Frame 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Percentage of participants
Normal (Core) [N=113, 111] 25.7 31.5
Mildly restricted (Core) [N=113, 111] 50.4 29.7
Moderately restricted (Core) [N=113, 111] 21.2 27.0
Severely restricted (Core) [N=113, 111] 2.7 8.1
Immobilized (Core) [N=113, 111] 0.0 3.6
Normal (24 weeks) [N=87, 79] 66.7 65.8
Mildly restricted (24 weeks) [N=87, 79] 31.0 29.1
Moderately Restricted (24 weeks) [N=87, 79] 2.3 3.8
Severely Restricted (24 weeks) [N=87, 79] 0.0 1.3
Immobilized (24 weeks) [N=87, 79] 0.0 0.0
23.Secondary Outcome
Title Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)
Hide Description Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).
Time Frame 7 days post dose (randomization), 24 weeks post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 113 115
Measure Type: Number
Unit of Measure: Percentage of participants
None (7 days post-dose) [N= 110, 107] 32.7 28.0
Mild (7 days post-dose) [N= 110, 107] 48.2 41.1
Moderate (7 days post-dose) [N= 110, 107] 16.4 16.8
Severe (7 days post-dose) [N= 110, 107] 2.7 12.1
Extreme (7 days post-dose) [N= 110, 107] 0.0 1.9
None (24 weeks post-dose) [N= 85, 78] 47.1 46.2
Mild (24 weeks post-dose) [N= 85, 78] 38.8 37.2
Moderate (24 weeks post-dose) [N= 85, 78] 12.9 15.4
Severe (24 weeks post-dose) [N= 85, 78] 1.2 1.3
Extreme (24 weeks post-dose) [N= 85, 78] 0.0 0.0
24.Secondary Outcome
Title Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)
Hide Description

Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

· Increasing/renewed gout pain in an affected joint before flare has resolved completely.

Time Frame 72 weeks overall
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
Overall Number of Participants Analyzed 113 115
Median (95% Confidence Interval)
Unit of Measure: days
222.0
(190.0 to 274.0)
119.0
(94 to 224.0)
25.Secondary Outcome
Title Flare Rate Per Year
Hide Description

Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

· Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Time Frame 72 weeks overall
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. Note that flare rate was calculated using only those new flares before switching.

Overall Number of Participants Analyzed 113 115
Mean (Standard Deviation)
Unit of Measure: New flares per patient per year
1.16  (1.511) 2.81  (4.399)
26.Secondary Outcome
Title High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab
Hide Description High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Mean (Standard Deviation)
Unit of Measure: mg/L
24 hours post dose (n= 45, 24) 28.9  (42.26) 26.0  (29.07)
72 hours post dose (n=45, 34) 10.6  (14.69) 7.0  (8.06)
7 days post dose (n=67, 39) 3.3  (3.38) 3.2  (3.57)
4 weeks post dose (n=52, 35) 9.2  (48.57) 3.2  (4.95)
8 weeks post dose (n=45, 37) 2.6  (3.00) 3.0  (6.74)
12 weeks post dose (n=42, 33) 6.5  (12.99) 4.3  (11.90)
27.Secondary Outcome
Title Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab
Hide Description Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Mean (Standard Deviation)
Unit of Measure: mg/L
24 hours post dose (n= 45, 27) 151.4  (310.09) 86.5  (188.46)
72 hours post dose (n=45, 36) 42.5  (116.89) 26.9  (73.37)
7 days post dose (n=67, 39) 5.4  (8.83) 4.9  (6.56)
4 weeks post dose (n=52, 35) 31.0  (193.64) 8.5  (19.75)
8 weeks post dose (n=45, 37) 4.2  (4.26) 5.4  (8.36)
12 weeks post dose (n=42, 33) 10.7  (24.62) 7.8  (22.98)
28.Secondary Outcome
Title Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
Hide Description The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Measure Type: Number
Unit of Measure: Percentage of participants
Very good (72 hours post dose) (n=61, 34) 21.3 22.9
Good (72 hours post dose) (n=61, 34) 41.0 57.1
Fair (72 hours post dose) (n=61, 34) 31.1 17.1
Poor (72 hours post dose) (n=61, 34) 6.6 2.9
Very poor (72 hours post dose) (n=61, 34) 0.0 0.0
Very Good (7 days post dose) (n=68, 34) 36.8 33.3
Good (7 days post dose) (n=68, 34) 52.9 63.9
Fair (7 days post dose) (n=68, 34) 10.3 0.0
Poor (7 days post dose) (n=68, 34) 0.0 0.0
Very Poor (7 days post dose) (n=68, 34) 0.0 2.8
29.Secondary Outcome
Title Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)
Hide Description Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Measure Type: Number
Unit of Measure: Percentage of participants
None (72 hours post dose) (n=66, 39) 19.7 20.5
Mild (72 hours post dose) (n=66, 39) 30.0 61.5
Moderate (72 hours post dose) (n=66, 39) 45.5 15.4
Severe (72 hours post dose) (n=66, 39) 4.5 0.0
Extreme (72 hours post dose) (n=66, 39) 0.0 2.6
None (7 days post dose) (n=65, 35) 41.5 57.1
Mild (7 days post dose) (n=65, 35) 38.5 34.3
Moderate (7 days post dose) (n=65, 35) 18.5 5.7
Severe (7 days post dose) (n=65, 35) 1.5 0.0
Extreme (7 days post dose) (n=65, 35) 0.0 2.9
30.Secondary Outcome
Title Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
Hide Description Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Measure Type: Number
Unit of Measure: Percentage of participants
Excellent (72 hours post dose) (n=60, 36) 15.0 19.4
Good (72 hours post dose) (n=60, 36) 26.7 44.4
Acceptable (72 hours post dose) (n=60, 36) 50.0 27.8
Slight (72 hours post dose) (n=60, 36) 6.7 2.8
Poor (72 hours post dose) (n=60, 36) 1.7 5.6
Excellent (7 days post dose) (n=68, 36) 23.5 27.8
Good (7 days post dose) (n=68, 36) 41.2 52.8
Acceptable (7 days post dose) (n=68, 36) 27.9 16.7
Slight (7 days post dose) (n=68, 36) 7.4 2.8
Poor (7 days post dose) (n=68, 36) 0.0 0.0
31.Secondary Outcome
Title Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab
Hide Description The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Measure Type: Number
Unit of Measure: Percentage of participants
No Pain (72 hours post dose) (n=61, 35) 27.9 28.6
Pain (72 hours post dose) (n=61, 35) 54.1 68.6
Pain and winces (72 hours post dose) (n=61, 35) 16.4 2.9
Pain, winces, withdraw(72 hrs post dose)(n=61, 35) 1.6 0.0
No pain (7 days post dose) (n=68, 36) 52.9 69.4
Pain (7 days post dose) (n=68, 36) 44.1 27.8
Pain and winces (7 days post dose) (n=68, 36) 2.9 2.8
Pain, winces, withdraw(72 hrs post dose)(n=61, 36) 0.0 0.0
32.Secondary Outcome
Title Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab
Hide Description The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Measure Type: Number
Unit of Measure: Percentage of participants
No Pain (72 hours post dose) (n=61, 35) 29.5 42.9
Pain (72 hours post dose) (n=61, 35) 42.6 48.6
Pain and winces (72 hours post dose) (n=61, 35) 24.6 8.6
Pain, winces, withdraw(72 hrs post dose)(n=61, 35) 3.3 0.0
No pain (7 days post dose) (n=68, 36) 64.7 75.0
Pain (7 days post dose) (n=68, 36) 25.0 16.7
Pain and winces (7 days post dose) (n=68, 36) 7.4 5.6
Pain, winces, withdraw(72 hrs post dose)(n=68, 36) 2.9 2.8
33.Secondary Outcome
Title Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab
Hide Description The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Time Frame 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Randomized to Canakinumab and Re-treated With Canakinumab Randomized to Triamcinolone and Switched to Canakinumab
Hide Arm/Group Description:

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

Overall Number of Participants Analyzed 69 39
Measure Type: Number
Unit of Measure: Percentage of participants
Absent (72 hours post dose) (n=61, 35) 82.0 80.0
Present (72 hours post dose) (n=61, 35) 18.0 20.0
Absent (7 days post dose) (n=67, 36) 95.5 94.4
Present (7 days post dose) (n=67, 36) 4.5 5.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Randomized to Canakinumab Randomized to Canakinumab :Before Re-treated With Canakinumab Randomized to Canakinumab :After Re-treated With Canakinumab All Randomized to Triamcinolone Acetonide (Triam) Randomized to Triam: Before Switched to Canakinumab Randomized to Triam: After Switched to Canakinumab
Hide Arm/Group Description

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.

All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab

All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
All-Cause Mortality
All Randomized to Canakinumab Randomized to Canakinumab :Before Re-treated With Canakinumab Randomized to Canakinumab :After Re-treated With Canakinumab All Randomized to Triamcinolone Acetonide (Triam) Randomized to Triam: Before Switched to Canakinumab Randomized to Triam: After Switched to Canakinumab
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
All Randomized to Canakinumab Randomized to Canakinumab :Before Re-treated With Canakinumab Randomized to Canakinumab :After Re-treated With Canakinumab All Randomized to Triamcinolone Acetonide (Triam) Randomized to Triam: Before Switched to Canakinumab Randomized to Triam: After Switched to Canakinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/113 (16.81%)   6/69 (8.70%)   8/69 (11.59%)   11/115 (9.57%)   2/39 (5.13%)   0/39 (0.00%) 
Cardiac disorders             
Acute myocardial infarction  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Angina pectoris  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Angina unstable  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Arrhythmia  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Cardiac failure  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Myocardial ischaemia  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Eye disorders             
Glaucoma  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Retinal artery occlusion  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Gastrointestinal disorders             
Diverticulum intestinal  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Gastritis  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Periproctitis  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
General disorders             
Device dislocation  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Infections and infestations             
Abscess jaw  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Device related infection  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Endocarditis  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Pneumococcal sepsis  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Pneumonia  1  1/113 (0.88%)  1/69 (1.45%)  1/69 (1.45%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Septic shock  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Staphylococcal infection  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Injury, poisoning and procedural complications             
Fibula fracture  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Meniscus lesion  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Investigations             
Prostatic specific antigen increased  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Metabolism and nutrition disorders             
Gout  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  2/115 (1.74%)  1/39 (2.56%)  0/39 (0.00%) 
Hyperglycaemia  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Hyperkalaemia  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders             
Lumbar spinal stenosis  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Spondylolisthesis  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basal cell carcinoma  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Colon cancer  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Nervous system disorders             
Cerebrovascular accident  1  2/113 (1.77%)  0/69 (0.00%)  2/69 (2.90%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Ischaemic stroke  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  1/39 (2.56%)  0/39 (0.00%) 
Radiculopathy  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Spinal cord ischaemia  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Transient ischaemic attack  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Vertebrobasilar insufficiency  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Renal and urinary disorders             
Nephrolithiasis  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Renal colic  1  1/113 (0.88%)  0/69 (0.00%)  1/69 (1.45%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Renal failure chronic  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Renal impairment  1  1/113 (0.88%)  1/69 (1.45%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pulmonary embolism  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  0/39 (0.00%) 
Vascular disorders             
Deep vein thrombosis  1  1/113 (0.88%)  0/69 (0.00%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  0/39 (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%
All Randomized to Canakinumab Randomized to Canakinumab :Before Re-treated With Canakinumab Randomized to Canakinumab :After Re-treated With Canakinumab All Randomized to Triamcinolone Acetonide (Triam) Randomized to Triam: Before Switched to Canakinumab Randomized to Triam: After Switched to Canakinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   47/113 (41.59%)   19/69 (27.54%)   19/69 (27.54%)   22/115 (19.13%)   7/39 (17.95%)   12/39 (30.77%) 
Infections and infestations             
Bronchitis  1  3/113 (2.65%)  1/69 (1.45%)  1/69 (1.45%)  4/115 (3.48%)  3/39 (7.69%)  3/39 (7.69%) 
Influenza  1  5/113 (4.42%)  1/69 (1.45%)  4/69 (5.80%)  1/115 (0.87%)  0/39 (0.00%)  1/39 (2.56%) 
Nasopharyngitis  1  8/113 (7.08%)  4/69 (5.80%)  2/69 (2.90%)  2/115 (1.74%)  1/39 (2.56%)  2/39 (5.13%) 
Upper respiratory tract infection  1  3/113 (2.65%)  2/69 (2.90%)  1/69 (1.45%)  3/115 (2.61%)  2/39 (5.13%)  1/39 (2.56%) 
Investigations             
Gamma-glutamyltransferase increased  1  6/113 (5.31%)  3/69 (4.35%)  1/69 (1.45%)  4/115 (3.48%)  1/39 (2.56%)  0/39 (0.00%) 
Metabolism and nutrition disorders             
Hyperlipidaemia  1  0/113 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/115 (0.87%)  0/39 (0.00%)  2/39 (5.13%) 
Hypertriglyceridaemia  1  5/113 (4.42%)  4/69 (5.80%)  0/69 (0.00%)  0/115 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  8/113 (7.08%)  2/69 (2.90%)  5/69 (7.25%)  2/115 (1.74%)  2/39 (5.13%)  1/39 (2.56%) 
Back pain  1  6/113 (5.31%)  4/69 (5.80%)  2/69 (2.90%)  0/115 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Osteoarthritis  1  7/113 (6.19%)  1/69 (1.45%)  2/69 (2.90%)  2/115 (1.74%)  0/39 (0.00%)  0/39 (0.00%) 
Nervous system disorders             
Headache  1  8/113 (7.08%)  3/69 (4.35%)  2/69 (2.90%)  2/115 (1.74%)  0/39 (0.00%)  1/39 (2.56%) 
Vascular disorders             
Hypertension  1  13/113 (11.50%)  5/69 (7.25%)  7/69 (10.14%)  10/115 (8.70%)  3/39 (7.69%)  3/39 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Bioanalytical results: With analytical method used, anti-canakinumab antibodies were detected in 10 patients. However, no patients showed any unexpected PK/ PD profile nor had adverse events suggestive of immunogenicity.
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
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01029652     History of Changes
Obsolete Identifiers: NCT01071213, NCT01160016
Other Study ID Numbers: CACZ885H2356
2009-015018-23 ( EudraCT Number )
CACZ885H2356E1 ( Other Identifier: Novartis )
CACZ885H2356E2 ( Other Identifier: Novartis )
First Submitted: December 9, 2009
First Posted: December 10, 2009
Results First Submitted: July 26, 2011
Results First Posted: November 18, 2011
Last Update Posted: January 30, 2014