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 Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.

Acute Gout Clinical Trial

— ß-RELIEVED-II  

Official title:

A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study and a 1 Year Open-label Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080131
• Other study ID #: CACZ885H2357
• Secondary ID: 2010-018913-32CA
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2010
• Last updated: December 24, 2013
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaNetherlands: Dutch Health Care InspectorateRussia: Pharmacological Committee, Ministry of HealthUnited States: Food and Drug AdministrationTaiwan: Taiwan Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide.

The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357.

The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.

Other known NCT identifiers

• NCT01137344
• NCT01194921

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Core Study:

Inclusion criteria:

• Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout

• Onset of current acute gout flare within 5 days prior to study entry

• Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)

• History of = 3 gout flares within the 12 months prior to study entry

• Contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) and/or colchicine

Exclusion criteria:

• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

• Presence of severe renal function impairment

• Use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry

• Live vaccinations within 3 months prior to randomization

• Requirement for administration of antibiotics against latent tuberculosis (TB)

• Refractory heart failure (Stage D)

• Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia

• Any active or recurrent bacterial, fungal, or viral infection

Extension Study 1:

Inclusion:

• Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.

Exclusion:

• Continuation in this extension study was considered inappropriate by the treating physician.

Extension Study 2:

Inclusion Criteria:

• Completion of the first extension study CACZ885H2357E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).

Exclusion Criteria:

-Continuation in this second extension study was considered inappropriate by the treating physician.

Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gout
• Gout

Intervention

Drug:
• Canakinumab 150 mg
Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).
• Triamcinolone acetonide 40 mg
Triamcinolone acetonide 40 mg was supplied as a suspension.
• Placebo to canakinumab
Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.
• Placebo to triamcinolone acetonide
Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.

Locations

Country	Name	City	State
Canada	Novartis Investigative site	Sainte Foy	Quebec
Canada	Novartis Investigative Site	St-John's	Newfoundland and Labrador
Canada	Novartis Investigative Site	Vancouver	British Columbia
China	Novartis Investigative Site	Kaohsiung	Taiwan
China	Novartis Investigative Site	Kaohsiung Hsien	Taiwan
China	Novartis Investigative Site	Taichung	Taiwan
China	Novartis Investigative Site	Taipei	Taiwan
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative site	Leeuwarden
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yekaterinburg
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Lovelace Scientific Resource	Austin	Texas
United States	Dolby Research, LLC	Baton Rouge	Louisiana
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwest Clinical Trials	Boise	Idaho
United States	Sonora Clinical Research, LLC	Boise	Idaho
United States	Tri-Cities Medical Research	Bristol	Tennessee
United States	Arthritis and Osteoporosis Medical Association	Brooklyn	New York
United States	Partners in Clinical Research	Bumberland	Rhode Island
United States	Providence Research	Burbank	California
United States	Diagnamics, Inc.	Carlsbad	California
United States	Medical Research South	Charleston	South Carolina
United States	Pharmacorp Clinical Trials, INC	Charleston	South Carolina
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	The Center For Nutrition and Preventive Medicine	Charlotte	North Carolina
United States	Clarkston Medical Group	Clarkston	Michigan
United States	Alpha Clinical Research	Clarksville	Tennessee
United States	Innovative Research of West Florida	Clearwater	Florida
United States	Tlm Medical Services Llc	Columbia	South Carolina
United States	Columbia Arthritis Center	Columbus	Ohio
United States	RST DAta Research	Conyers	Georgia
United States	Clinical Res Ct of CT - Arthritis Associates of CT/NY, LLC	Danbury	Connecticut
United States	Novartis Investigative site	Danville	Virginia
United States	STAT Research, Inc.	Dayton	Ohio
United States	Q Clinical Research	Decatur	Georgia
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Deaconess Clinic	Evansville	Indiana
United States	Med Investigations	Fair Oaks	California
United States	L Kage Healthcare Services	Flint	Michigan
United States	Novartis Investigative site	Foley	Alabama
United States	Arthritis and Osteoporosis Associates	Freehold	New Jersey
United States	West Michigan Rheumatology	Grand Rapids	Michigan
United States	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina
United States	Clinical Research Advantage, Inc	Henderson	Nevada
United States	Unifour Medical Research Associates	Hickory	North Carolina
United States	Rheumatic Disease Clinical Research Center, Llc	Houston	Texas
United States	Arthritis Associates of Mississippi	Jackson	Mississippi
United States	CRC of Jackson	Jackson	Mississippi
United States	Phillips Medical Center	Jackson	Mississippi
United States	The Arthritis Clinic	Jackson	Tennessee
United States	The Jackson Clinic	Jackson	Tennessee
United States	MultiSpecialty Clinical Research	Johnson City	Tennessee
United States	Health Awareness	Jupiter	Florida
United States	Gulf Coast Research, LLC	Lafayette	Louisiana
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	*Private Practice*	Lansing	Michigan
United States	Leander Healthcare Center	Leander	Texas
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	Valerius Medical Group and Research Center of Long Branch	Long Beach	California
United States	Clinical Trials Management	Metairie	Louisiana
United States	Montana Medical Research	Missoula	Montana
United States	Horizon Research Group, Inc.	Mobile	Alabama
United States	Arthritis and Diabetes Clinic	Monroe	Louisiana
United States	Accurate Clinical Research	Nassau Bay	Texas
United States	UMDNJ Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Health Research of Hampton Roads	Newport News	Virginia
United States	North Hills Family Practice	North Richard Hills	Texas
United States	Lucita M. Cruz, M.D., Inc.	Norwalk	California
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Health Research of Oklahoma, PLLC	Oklahoma City	Oklahoma
United States	Heartland Clinical Research, Inc.	Omaha	Nebraska
United States	Quality Clinical Research	Omaha	Nebraska
United States	Sierra Clinical Research	Orangevale	California
United States	Pinnacle Medical Research	Overland Park	Kansas
United States	Pines Research, LLC Pembroke Clinical Trials	Pembroke Pines	Florida
United States	Sun Valley Arthritis Center, Ltd	Peoria	Arizona
United States	Philadelphia VA medical Center	Philadelphia	Pennsylvania
United States	DMI Healthcare Group, Inc.	Pinellas Park	Florida
United States	Chaparral Medical Grp, INC Clinical Research	Pomona	California
United States	Harbin Clinic	Rome	Georgia
United States	Andrew J. Porges, MD, PC	Roslyn	New York
United States	River City Clinical Research	Sacramento	California
United States	Arthritis Associates	San Antonio	California
United States	Arthritis Center South Texas	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Ritchken and First MDs	San Diego	California
United States	Rochester clinical Research	San Diego	California
United States	Huntington Medical Foundation	San Marino	California
United States	Crest Clinical Trials	Santa Ana	California
United States	Jones Family Practice, PA	Shelby	North Carolina
United States	Regional Research Specialists	Shreveport	Louisiana
United States	The Family Doctors	Shreveport	Louisiana
United States	The Arthritis Center	Springfield	Illinois
United States	Tampa Medical Group, P.A.	Tampa	Florida
United States	Oakland Medical Research Center	Troy	Michigan
United States	Genova Clinical Research	Tucson	Arizona
United States	Orange County Research Center	Tustin	California
United States	Community Research Partners, Inc.	Varnville	South Carolina
United States	Community Research Partners, Inc.	Varnville	South Carolina
United States	Progressive Clinical Research	Vista	California
United States	MASS Research, LLC	Waltham	Massachusetts
United States	Center for Clinical Trials of San Gabriel	West Covina	California
United States	Center for Rheumatology & Bone Research	Wheaton	Maryland
United States	Wichita Clinic	Wichita	Kansas
United States	Ohio Clinical Research, LLC	Willoughby Hills	Ohio
United States	Humility of Mary Health Partners DBA St. Elizabeth Health Ce	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  China,  Netherlands,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First New Flare: Survival Analysis During the 12 Weeks of Study	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.	Baseline to 12 weeks	No
Primary	Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose	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 analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.	72 hours post-dose (randomization)	No
Primary	Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks	This was primary endpoint of extension study 1. 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. A 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.	During 24 weeks overall	Yes
Primary	Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)	This was the primary endpoint of extension study 2. An adverse event was 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.	72 weeks	Yes
Secondary	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 (VAS)	Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 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.	Baseline to 7 days post-dose (randomization)	No
Secondary	Time to Complete Resolution of Pain; Survival Analysis	Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.	Baseline to 7 days post-dose (randomization)	No
Secondary	SF 36 Physical Function Score at Week 12	SF-36 measures impact of disease on overall quality of life (QoL). 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 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. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.	Week 12	No
Secondary	Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study	The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.	Baseline to Week 12	No
Secondary	Pharmacokinetic Concentrations	Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.	12 weeks post-dose	No
Secondary	Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)	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), from 6 hours to 7 days 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.	6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)	No
Secondary	Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)	Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.	6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).	No
Secondary	Time to the First New Gout Flare During 24 Weeks	Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a 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.; Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.	From randomization to the end of the first extension period (24 weeks).	No
Secondary	Mean Number of New Gout Flares Per Patient During 24 Weeks	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.; Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.	24 weeks	No
Secondary	Time to First Intake of Rescue Medication	Participants 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, participants were allowed to take a maximum of 30 mg of oral prednisolone 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.; Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.; Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks).	For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).	No
Secondary	Percentage of Participants Who Took Rescue Medication	Participants 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, participants were allowed to take a maximum of 30 mg of oral prednisolone 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.; Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.	For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).	No
Secondary	Amount of Rescue Medication Taken	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 prednisolone 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.	For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).	No
Secondary	Physician's Global Assessment of Response to Treatment	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 own assessments (pain intensity and patient's global assessment of response to treatment).	72 hours post-dose and 24-weeks post-dose.	No
Secondary	Patient's Global Assessment of Response to Treatment	Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.	72 hours post-dose and 24 weeks post-dose	No
Secondary	Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint	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 participants in each category is reported.	72 hours post-dose and 24 weeks post-dose	No
Secondary	Physician's Assessment of Range of Motion of the Most Affected Joint	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 participants in each category is reported.	72 hours post-dose and 24 weeks post-dose	No
Secondary	High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels	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. Analyses 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.	72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).	No
Secondary	Patient's Assessment of Gout Pain Intensity in the Most Affected Joint	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).	72 hours post-dose and 24 weeks post-dose	No
Secondary	Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme	For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.	From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).	No
Secondary	Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks	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.	From randomization to the end of the second extension period (72 weeks).	No
Secondary	Flare Rate Per Year	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.; Participants met the 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.; Participants did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before the flare has resolved completely.; Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate.	From randomization to the end of the second extension period (72 weeks).	No
Secondary	Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab	Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).; Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No
Secondary	Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab	Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No
Secondary	Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab	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 or very poor.; The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments.; Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No
Secondary	Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab	The study physician assessed the most affected joint for tenderness on the following 4-point scale: no pain; participant states that "there is pain; participant states "there is pain and winces"; participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.; Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No
Secondary	Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab	The study physician assessed the most affected joint for swelling on the following 4-point scale: no swelling; palpable; visible; bulging beyond the joint margins.; Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No
Secondary	Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab	The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.; Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No
Secondary	High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab	High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.; Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No
Secondary	Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab	Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.; Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.	24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.	No