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
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
The purpose of the 12-week core 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 CACZ885H2356.

 The purpose of the second 48 week open-label extension study was to collect additional
 long-term safety and tolerability data in patients who have completed the first extension
 study CACZ885H2356E1.
Masking:

 Core: Double Blind (Subject, Investigator) Extension 1: Double Blind (Subject, Investigator)
 Extension 2: Open-label, terminated
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, intolerance, or lack of efficacy for non-steroidal anti-inflammatory
 drugs (NSAIDs) 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 Completed of the first extension study CACZ885H2356E1. A patient was defined as
 completing the first extension study if they completed the study up to and including Visit
 10).

 Exclusion

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

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