Trial Outcomes & Findings for 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 (NCT NCT01029652)

Last Updated: 2014-01-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

230 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-01-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Canakinumab 150 mg 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	Triamcinolone Acetonide 40 mg 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 .
Core Study (0-12 Weeks) STARTED	115	115
Core Study (0-12 Weeks) Full Analysis Set (FAS), Safety Set	113	115
Core Study (0-12 Weeks) COMPLETED	109	105
Core Study (0-12 Weeks) NOT COMPLETED	6	10
Extension Study 1 (12-24 Weeks) STARTED	90	85
Extension Study 1 (12-24 Weeks) COMPLETED	87	80
Extension Study 1 (12-24 Weeks) NOT COMPLETED	3	5
Extension Study 2 (25-72 Weeks) STARTED	69	66
Extension Study 2 (25-72 Weeks) Re-treated With or Switch to Canakinumab	69	39
Extension Study 2 (25-72 Weeks) COMPLETED	68	63
Extension Study 2 (25-72 Weeks) NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Canakinumab 150 mg 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	Triamcinolone Acetonide 40 mg 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 .
Core Study (0-12 Weeks) Unsatisfactory therapeutic effect	0	4
Core Study (0-12 Weeks) Patient Withdrew Consent	1	3
Core Study (0-12 Weeks) Lost to Follow-up	3	1
Core Study (0-12 Weeks) Administrative problems	2	1
Core Study (0-12 Weeks) Death	0	1
Extension Study 1 (12-24 Weeks) Unsatisfactory therapeutic effect	0	1
Extension Study 1 (12-24 Weeks) Lost to Follow-up	2	3
Extension Study 1 (12-24 Weeks) Protocol Deviation	1	0
Extension Study 1 (12-24 Weeks) Withdrawal by Subject	0	1
Extension Study 2 (25-72 Weeks) Death	1	1
Extension Study 2 (25-72 Weeks) Unsatisfactory therapeutic effect	0	1
Extension Study 2 (25-72 Weeks) Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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 n=228 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 11.18 • n=5 Participants	54.6 years STANDARD_DEVIATION 10.71 • n=7 Participants	54.3 years STANDARD_DEVIATION 10.93 • n=5 Participants
Age, Customized < 65 years	92 participants n=5 Participants	92 participants n=7 Participants	184 participants n=5 Participants
Age, Customized ≥ 65 - 74 years	16 participants n=5 Participants	21 participants n=7 Participants	37 participants n=5 Participants
Age, Customized ≥ 75 years	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	108 Participants n=7 Participants	209 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Time to First New Flare	NA Days The median time to first new flare could not be estimated because \<50% of patients had a new flare during the time period.	NA Days The median time to first new flare could not be estimated because \<50% of patients had a new flare during the time period.	—	—	—	—

PRIMARY outcome

Timeframe: 72 hours post-dose (randomization)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=112 Participants 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.	Triamcinolone Acetonide 40 mg n=111 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)	28.1 mm Standard Error 2.42	39.5 mm Standard Error 2.44	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks overall

Population: Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall) Death	0 Participants	1 Participants	—	—	—	—
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall) Serious Adverse Event	11 Participants	6 Participants	—	—	—	—
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall) Adverse Event	71 Participants	56 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 72 weeks overall

Population: Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=69 Participants 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.	Randomized to Canakinumab :After Re-treated With Canakinumab n=69 Participants 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	Randomized to Triamcinolone Acetonide (Triam) n=115 Participants 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	Randomized to Triam: Before Switched to Canakinumab n=39 Participants 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	Randomized to Triam: After Switched to Canakinumab n=39 Participants 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
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall) Adverse Event	76 Participants	41 Participants	38 Participants	60 Participants	20 Participants	19 Participants
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall) Death	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall) Serious Adverse Event	19 Participants	6 Participants	8 Participants	11 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 7 days post dose (randomization)

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=112 Participants 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.	Triamcinolone Acetonide 40 mg n=111 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
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)	48.0 Hours Interval 24.0 to 60.0	72.0 Hours Interval 48.0 to 96.0	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post-dose (randomization)

Population: 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 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Time to Complete Resolution of Pain	NA Hours The median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period.	NA Hours The median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period.	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post-dose (randomization)

Population: 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 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Percentage of Participants With Complete Resolution of Pain	34.5 Percentage of participants Interval 26.6 to 44.1	31.3 Percentage of participants Interval 23.7 to 40.6	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: 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 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks	18.6 Percentage of participants	34.8 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Mean Number of New Gout Flares Per Patient	0.21 New flares/patient/12 weeks Standard Deviation 0.472	0.53 New flares/patient/12 weeks Standard Deviation 0.892	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=96 Participants 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.	Triamcinolone Acetonide 40 mg n=92 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
SF36 Physical Function Score at Week 12	71.76 Units on a scale Standard Error 2.688	71.48 Units on a scale Standard Error 2.745	—	—	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Time to First New Flare	NA Days The median time to first new flare could not be estimated because \<50% of patients had a new flare during the time period.	119 Days Interval 94.0 to The upper limit was not estimable in the study as it is longer than the duration of the study (24 weeks).	—	—	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study	0.40 New flares/patient/24 weeks Standard Deviation 0.634	0.87 New flares/patient/24 weeks Standard Deviation 1.104	—	—	—	—

SECONDARY outcome

Timeframe: 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Population: 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.

The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=35 Participants 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.	Triamcinolone Acetonide 40 mg n=43 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Time to First Intake of Rescue Medication After the Last Post Baseline Flare.	NA Hours Interval 12.0 to The data were not estimable as \<50% patients took rescue medication.	NA Hours Interval 11.0 to The data were not estimable as \<50% patients took rescue medication.	—	—	—	—

SECONDARY outcome

Timeframe: 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=35 Participants 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.	Triamcinolone Acetonide 40 mg n=41 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension	34.6 mm Standard Error 4.35	44.9 mm Standard Error 4.01	—	—	—	—

SECONDARY outcome

Timeframe: Last post-baseline flare (during 24 weeks overall)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=35 Participants 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.	Triamcinolone Acetonide 40 mg n=43 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale) Moderate	14.3 Percentage of participants	16.3 Percentage of participants	—	—	—	—
Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale) None	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale) Mild	0.0 Percentage of participants	2.3 Percentage of participants	—	—	—	—
Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale) Severe	77.1 Percentage of participants	60.5 Percentage of participants	—	—	—	—
Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale) Extreme	8.6 Percentage of participants	20.9 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 7 days last post-baseline flare (during 24 weeks)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=35 Participants 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.	Triamcinolone Acetonide 40 mg n=43 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Amount of Rescue Medication Taken Codeine	7.7 mg Standard Deviation 25.56	46.0 mg Standard Deviation 118.26	—	—	—	—
Amount of Rescue Medication Taken Prednisolone/Prednisone	4.1 mg Standard Deviation 17.34	21.6 mg Standard Deviation 47.42	—	—	—	—
Amount of Rescue Medication Taken Acetaminophen	1931.4 mg Standard Deviation 3266.12	2058.1 mg Standard Deviation 3331.33	—	—	—	—

SECONDARY outcome

Timeframe: during 12 weeks core, 24 weeks overall

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Percentage of Participants Who Took Rescue Medication 12 weeks :Core (N=113, 115)	31.0 Percentage of participants	52.2 Percentage of participants Interval 30.0 to	—	—	—	—
Percentage of Participants Who Took Rescue Medication 24 weeks: Overall (N=35, 43)	48.6 Percentage of participants	44.2 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall hsCRP : Core(n= 109, 107)	4.50 mg/L Interval 3.96 to 5.12	7.08 mg/L Interval 6.22 to 8.07	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall SAA protein : Core (n=105, 106)	6.77 mg/L Interval 5.57 to 8.21	17.00 mg/L Interval 14.01 to 20.62	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall hsCRP : 24 weeks(n= 31, 32)	5.18 mg/L Interval 3.79 to 7.09	7.18 mg/L Interval 5.27 to 9.77	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall SAA protein : 24 weeks (n=28, 33)	11.43 mg/L Interval 7.76 to 16.84	21.11 mg/L Interval 14.78 to 30.16	—	—	—	—

SECONDARY outcome

Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Population: 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Physician's Global Assessment of Response to Treatment Very Good ( 24 weeks) [N=87, 79]	43.7 Percentage of participants	27.8 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Good (24 weeks) [N=87, 79]	50.6 Percentage of participants	50.6 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Very poor (Core) [N=113, 110]	1.8 Percentage of participants	7.3 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Fair (24 weeks) [N=87, 79]	5.7 Percentage of participants	17.7 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Very good (Core) [N=113,110]	16.8 Percentage of participants	15.5 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Good (Core) [N=113, 110]	47.8 Percentage of participants	30.0 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Fair (Core) [N= 113, 110]	26.5 Percentage of participants	32.7 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Poor (Core) [N= 113, 110]	7.1 Percentage of participants	14.5 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Poor (24 weeks) [N=87, 79]	0.0 Percentage of participants	3.8 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment Very Poor (24 weeks) [N=87, 79]	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Patient's Global Assessment of Response to Treatment Acceptable (Core) [N=113, 111]	37.2 Percentage of participants	30.6 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Slight (Core) [N=113, 111]	8.8 Percentage of participants	12.6 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Excellent (24 weeks) [N=87, 78]	31 Percentage of participants	17.9 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Good (24 weeks) [N=87, 78]	46 Percentage of participants	44.9 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Acceptable (24 weeks) [N=87, 78]	20.7 Percentage of participants	25.6 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Slight (24 weeks) [N=87, 78]	1.1 Percentage of participants	9.0 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Poor (24 weeks) [N=87, 78]	1.1 Percentage of participants	2.6 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Excellent (Core) [N=113, 111]	12.4 Percentage of participants	12.6 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Good (Core) [N=113, 111]	38.9 Percentage of participants	28.8 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment Poor (Core) [N=113, 111]	2.7 Percentage of participants	15.3 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint TENDERNESS - No pain (Core) [N=113, 110]	33.6 Percentage of participants	26.4 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Pain (Core) [N=113, 110]	56.6 Percentage of participants	51.8 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Pain and winces (Core) [N=113, 110]	8.0 Percentage of participants	17.3 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Pain,winces,withdraws (Core) [N=113,110]	1.8 Percentage of participants	4.5 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint SWELLING - No swelling (Core) [N=113, 110]	38.1 Percentage of participants	30.0 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Palpable (Core) [N=113, 110]	38.9 Percentage of participants	35.5 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Bulging beyond joint margin (Core) [N=113, 110]	1.8 Percentage of participants	5.5 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint ERYTHEMA - Absent (Core) [N=112, 109]	78.6 Percentage of participants	65.1 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Pain (24 weeks) [N=87, 80]	17.2 Percentage of participants	13.8 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Pain and winces (24 weeks) [N=87, 80]	0.0 Percentage of participants	1.3 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Pain,winces,withdraws (24 weeks) [N=87, 80]	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Palpable (24 weeks) [N=87, 80]	8.0 Percentage of participants	5.0 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Visible (24 weeks) [N=87, 80]	3.4 Percentage of participants	1.3 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Visible (Core) [N=113, 110]	21.2 Percentage of participants	29.1 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Present (Core) [N=112, 109]	21.4 Percentage of participants	34.9 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint TENDERNESS - No pain (24 weeks) [N=87, 80]	82.8 Percentage of participants	85.0 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint SWELLING - No swelling (24 weeks) [N=87, 80]	88.5 Percentage of participants	93.8 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Bulging beyond joint margin (24 week)[N=87,80]	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint ERYTHEMA - Absent (24 weeks) [N=87, 80]	98.9 Percentage of participants	100 Percentage of participants	—	—	—	—
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint Present (24 weeks) [N=87, 80]	1.1 Percentage of participants	0.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Physician's Assessment of Range of Motion of the Most Affected Joint Mildly restricted (Core) [N=113, 111]	50.4 Percentage of participants	29.7 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Normal (24 weeks) [N=87, 79]	66.7 Percentage of participants	65.8 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Mildly restricted (24 weeks) [N=87, 79]	31.0 Percentage of participants	29.1 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Moderately Restricted (24 weeks) [N=87, 79]	2.3 Percentage of participants	3.8 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Severely Restricted (24 weeks) [N=87, 79]	0.0 Percentage of participants	1.3 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Normal (Core) [N=113, 111]	25.7 Percentage of participants	31.5 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Moderately restricted (Core) [N=113, 111]	21.2 Percentage of participants	27.0 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Severely restricted (Core) [N=113, 111]	2.7 Percentage of participants	8.1 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Immobilized (Core) [N=113, 111]	0.0 Percentage of participants	3.6 Percentage of participants	—	—	—	—
Physician's Assessment of Range of Motion of the Most Affected Joint Immobilized (24 weeks) [N=87, 79]	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post dose (randomization), 24 weeks post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Extreme (24 weeks post-dose) [N= 85, 78]	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) None (7 days post-dose) [N= 110, 107]	32.7 Percentage of participants	28.0 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Mild (7 days post-dose) [N= 110, 107]	48.2 Percentage of participants	41.1 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Moderate (7 days post-dose) [N= 110, 107]	16.4 Percentage of participants	16.8 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Severe (7 days post-dose) [N= 110, 107]	2.7 Percentage of participants	12.1 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Extreme (7 days post-dose) [N= 110, 107]	0.0 Percentage of participants	1.9 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) None (24 weeks post-dose) [N= 85, 78]	47.1 Percentage of participants	46.2 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Mild (24 weeks post-dose) [N= 85, 78]	38.8 Percentage of participants	37.2 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Moderate (24 weeks post-dose) [N= 85, 78]	12.9 Percentage of participants	15.4 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale) Severe (24 weeks post-dose) [N= 85, 78]	1.2 Percentage of participants	1.3 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 72 weeks overall

Population: 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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)	222.0 days Interval 190.0 to 274.0	119.0 days Interval 94.0 to 224.0	—	—	—	—

SECONDARY outcome

Timeframe: 72 weeks overall

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=113 Participants 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.	Triamcinolone Acetonide 40 mg n=115 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Flare Rate Per Year	1.16 New flares per patient per year Standard Deviation 1.511 • Interval 0.97 to 1.51	2.81 New flares per patient per year Standard Deviation 4.399 • Interval 1.72 to 2.71	—	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: 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

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab 24 hours post dose (n= 45, 24)	28.9 mg/L Standard Deviation 42.26	26.0 mg/L Standard Deviation 29.07	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab 72 hours post dose (n=45, 34)	10.6 mg/L Standard Deviation 14.69	7.0 mg/L Standard Deviation 8.06	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab 7 days post dose (n=67, 39)	3.3 mg/L Standard Deviation 3.38	3.2 mg/L Standard Deviation 3.57	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab 4 weeks post dose (n=52, 35)	9.2 mg/L Standard Deviation 48.57	3.2 mg/L Standard Deviation 4.95	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab 8 weeks post dose (n=45, 37)	2.6 mg/L Standard Deviation 3.00	3.0 mg/L Standard Deviation 6.74	—	—	—	—
High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab 12 weeks post dose (n=42, 33)	6.5 mg/L Standard Deviation 12.99	4.3 mg/L Standard Deviation 11.90	—	—	—	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab 24 hours post dose (n= 45, 27)	151.4 mg/L Standard Deviation 310.09	86.5 mg/L Standard Deviation 188.46	—	—	—	—
Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab 72 hours post dose (n=45, 36)	42.5 mg/L Standard Deviation 116.89	26.9 mg/L Standard Deviation 73.37	—	—	—	—
Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab 7 days post dose (n=67, 39)	5.4 mg/L Standard Deviation 8.83	4.9 mg/L Standard Deviation 6.56	—	—	—	—
Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab 4 weeks post dose (n=52, 35)	31.0 mg/L Standard Deviation 193.64	8.5 mg/L Standard Deviation 19.75	—	—	—	—
Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab 8 weeks post dose (n=45, 37)	4.2 mg/L Standard Deviation 4.26	5.4 mg/L Standard Deviation 8.36	—	—	—	—
Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab 12 weeks post dose (n=42, 33)	10.7 mg/L Standard Deviation 24.62	7.8 mg/L Standard Deviation 22.98	—	—	—	—

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Very good (72 hours post dose) (n=61, 34)	21.3 Percentage of participants	22.9 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Good (72 hours post dose) (n=61, 34)	41.0 Percentage of participants	57.1 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Fair (72 hours post dose) (n=61, 34)	31.1 Percentage of participants	17.1 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Poor (72 hours post dose) (n=61, 34)	6.6 Percentage of participants	2.9 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Very poor (72 hours post dose) (n=61, 34)	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Very Good (7 days post dose) (n=68, 34)	36.8 Percentage of participants	33.3 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Good (7 days post dose) (n=68, 34)	52.9 Percentage of participants	63.9 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Fair (7 days post dose) (n=68, 34)	10.3 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Poor (7 days post dose) (n=68, 34)	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Very Poor (7 days post dose) (n=68, 34)	0.0 Percentage of participants	2.8 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Severe (72 hours post dose) (n=66, 39)	4.5 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Moderate (7 days post dose) (n=65, 35)	18.5 Percentage of participants	5.7 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) None (72 hours post dose) (n=66, 39)	19.7 Percentage of participants	20.5 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Mild (72 hours post dose) (n=66, 39)	30.0 Percentage of participants	61.5 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Moderate (72 hours post dose) (n=66, 39)	45.5 Percentage of participants	15.4 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Extreme (72 hours post dose) (n=66, 39)	0.0 Percentage of participants	2.6 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) None (7 days post dose) (n=65, 35)	41.5 Percentage of participants	57.1 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Mild (7 days post dose) (n=65, 35)	38.5 Percentage of participants	34.3 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Severe (7 days post dose) (n=65, 35)	1.5 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale) Extreme (7 days post dose) (n=65, 35)	0.0 Percentage of participants	2.9 Percentage of participants	—	—	—	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Good (7 days post dose) (n=68, 36)	41.2 Percentage of participants	52.8 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Excellent (72 hours post dose) (n=60, 36)	15.0 Percentage of participants	19.4 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Good (72 hours post dose) (n=60, 36)	26.7 Percentage of participants	44.4 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Acceptable (72 hours post dose) (n=60, 36)	50.0 Percentage of participants	27.8 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Slight (72 hours post dose) (n=60, 36)	6.7 Percentage of participants	2.8 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Poor (72 hours post dose) (n=60, 36)	1.7 Percentage of participants	5.6 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Excellent (7 days post dose) (n=68, 36)	23.5 Percentage of participants	27.8 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Acceptable (7 days post dose) (n=68, 36)	27.9 Percentage of participants	16.7 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Slight (7 days post dose) (n=68, 36)	7.4 Percentage of participants	2.8 Percentage of participants	—	—	—	—
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab Poor (7 days post dose) (n=68, 36)	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab Pain, winces, withdraw(72 hrs post dose)(n=61, 35)	1.6 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab No Pain (72 hours post dose) (n=61, 35)	27.9 Percentage of participants	28.6 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab Pain (72 hours post dose) (n=61, 35)	54.1 Percentage of participants	68.6 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab Pain and winces (72 hours post dose) (n=61, 35)	16.4 Percentage of participants	2.9 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab No pain (7 days post dose) (n=68, 36)	52.9 Percentage of participants	69.4 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab Pain (7 days post dose) (n=68, 36)	44.1 Percentage of participants	27.8 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab Pain and winces (7 days post dose) (n=68, 36)	2.9 Percentage of participants	2.8 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab Pain, winces, withdraw(72 hrs post dose)(n=61, 36)	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab No Pain (72 hours post dose) (n=61, 35)	29.5 Percentage of participants	42.9 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab Pain (72 hours post dose) (n=61, 35)	42.6 Percentage of participants	48.6 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab Pain and winces (72 hours post dose) (n=61, 35)	24.6 Percentage of participants	8.6 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab Pain, winces, withdraw(72 hrs post dose)(n=61, 35)	3.3 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab No pain (7 days post dose) (n=68, 36)	64.7 Percentage of participants	75.0 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab Pain (7 days post dose) (n=68, 36)	25.0 Percentage of participants	16.7 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab Pain and winces (7 days post dose) (n=68, 36)	7.4 Percentage of participants	5.6 Percentage of participants	—	—	—	—
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab Pain, winces, withdraw(72 hrs post dose)(n=68, 36)	2.9 Percentage of participants	2.8 Percentage of participants	—	—	—	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Canakinumab 150 mg n=69 Participants 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.	Triamcinolone Acetonide 40 mg n=39 Participants 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.	Randomized to Canakinumab :After 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	Randomized to Triamcinolone Acetonide (Triam) 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	Randomized to Triam: 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 before switched to canakinumab	Randomized to Triam: After 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
Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab Absent (72 hours post dose) (n=61, 35)	82.0 Percentage of participants	80.0 Percentage of participants	—	—	—	—
Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab Present (72 hours post dose) (n=61, 35)	18.0 Percentage of participants	20.0 Percentage of participants	—	—	—	—
Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab Absent (7 days post dose) (n=67, 36)	95.5 Percentage of participants	94.4 Percentage of participants	—	—	—	—
Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab Present (7 days post dose) (n=67, 36)	4.5 Percentage of participants	5.6 Percentage of participants	—	—	—	—

Adverse Events

All Randomized to Canakinumab

Serious events: 19 serious events

Other events: 47 other events

Deaths: 0 deaths

Randomized to Canakinumab :Before Re-treated With Canakinumab

Serious events: 6 serious events

Other events: 19 other events

Deaths: 0 deaths

Randomized to Canakinumab :After Re-treated With Canakinumab

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

All Randomized to Triamcinolone Acetonide (Triam)

Serious events: 11 serious events

Other events: 22 other events

Deaths: 0 deaths

Randomized to Triam: Before Switched to Canakinumab

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Randomized to Triam: After Switched to Canakinumab

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Randomized to Canakinumab n=113 participants at risk 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.	Randomized to Canakinumab :Before Re-treated With Canakinumab n=69 participants at risk 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	Randomized to Canakinumab :After Re-treated With Canakinumab n=69 participants at risk 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	All Randomized to Triamcinolone Acetonide (Triam) n=115 participants at risk 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	Randomized to Triam: Before Switched to Canakinumab n=39 participants at risk 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	Randomized to Triam: After Switched to Canakinumab n=39 participants at risk 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
Cardiac disorders Acute myocardial infarction	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Cardiac disorders Angina pectoris	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Cardiac disorders Angina unstable	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Cardiac disorders Arrhythmia	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Cardiac disorders Cardiac failure	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Cardiac disorders Myocardial ischaemia	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Eye disorders Glaucoma	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Eye disorders Retinal artery occlusion	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Gastrointestinal disorders Diverticulum intestinal	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Gastrointestinal disorders Gastritis	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Gastrointestinal disorders Periproctitis	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
General disorders Device dislocation	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Infections and infestations Abscess jaw	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Infections and infestations Device related infection	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Infections and infestations Endocarditis	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Infections and infestations Pneumococcal sepsis	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Infections and infestations Pneumonia	0.88% 1/113	1.4% 1/69	1.4% 1/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Infections and infestations Septic shock	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Infections and infestations Staphylococcal infection	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Injury, poisoning and procedural complications Fibula fracture	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Investigations Prostatic specific antigen increased	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Metabolism and nutrition disorders Gout	0.00% 0/113	0.00% 0/69	0.00% 0/69	1.7% 2/115	2.6% 1/39	0.00% 0/39
Metabolism and nutrition disorders Hyperglycaemia	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Metabolism and nutrition disorders Hyperkalaemia	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Nervous system disorders Cerebrovascular accident	1.8% 2/113	0.00% 0/69	2.9% 2/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Nervous system disorders Ischaemic stroke	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	2.6% 1/39	0.00% 0/39
Nervous system disorders Radiculopathy	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Nervous system disorders Spinal cord ischaemia	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Nervous system disorders Transient ischaemic attack	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Renal and urinary disorders Nephrolithiasis	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Renal and urinary disorders Renal colic	0.88% 1/113	0.00% 0/69	1.4% 1/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Renal and urinary disorders Renal failure chronic	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Renal and urinary disorders Renal impairment	0.88% 1/113	1.4% 1/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	0.00% 0/39
Vascular disorders Deep vein thrombosis	0.88% 1/113	0.00% 0/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	0.00% 0/39

Other adverse events

Other adverse events
Measure	All Randomized to Canakinumab n=113 participants at risk 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.	Randomized to Canakinumab :Before Re-treated With Canakinumab n=69 participants at risk 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	Randomized to Canakinumab :After Re-treated With Canakinumab n=69 participants at risk 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	All Randomized to Triamcinolone Acetonide (Triam) n=115 participants at risk 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	Randomized to Triam: Before Switched to Canakinumab n=39 participants at risk 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	Randomized to Triam: After Switched to Canakinumab n=39 participants at risk 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
Infections and infestations Bronchitis	2.7% 3/113	1.4% 1/69	1.4% 1/69	3.5% 4/115	7.7% 3/39	7.7% 3/39
Infections and infestations Influenza	4.4% 5/113	1.4% 1/69	5.8% 4/69	0.87% 1/115	0.00% 0/39	2.6% 1/39
Infections and infestations Nasopharyngitis	7.1% 8/113	5.8% 4/69	2.9% 2/69	1.7% 2/115	2.6% 1/39	5.1% 2/39
Infections and infestations Upper respiratory tract infection	2.7% 3/113	2.9% 2/69	1.4% 1/69	2.6% 3/115	5.1% 2/39	2.6% 1/39
Investigations Gamma-glutamyltransferase increased	5.3% 6/113	4.3% 3/69	1.4% 1/69	3.5% 4/115	2.6% 1/39	0.00% 0/39
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/113	0.00% 0/69	0.00% 0/69	0.87% 1/115	0.00% 0/39	5.1% 2/39
Metabolism and nutrition disorders Hypertriglyceridaemia	4.4% 5/113	5.8% 4/69	0.00% 0/69	0.00% 0/115	0.00% 0/39	2.6% 1/39
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 8/113	2.9% 2/69	7.2% 5/69	1.7% 2/115	5.1% 2/39	2.6% 1/39
Musculoskeletal and connective tissue disorders Back pain	5.3% 6/113	5.8% 4/69	2.9% 2/69	0.00% 0/115	0.00% 0/39	2.6% 1/39
Musculoskeletal and connective tissue disorders Osteoarthritis	6.2% 7/113	1.4% 1/69	2.9% 2/69	1.7% 2/115	0.00% 0/39	0.00% 0/39
Nervous system disorders Headache	7.1% 8/113	4.3% 3/69	2.9% 2/69	1.7% 2/115	0.00% 0/39	2.6% 1/39
Vascular disorders Hypertension	11.5% 13/113	7.2% 5/69	10.1% 7/69	8.7% 10/115	7.7% 3/39	7.7% 3/39

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862 778-8300

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER