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.

Core Study: Inclusion criteria:

• Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for theclassification 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-steroidalanti-inflammatory drugs (NSAID) and/or colchicine

Exclusion criteria:

• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or otheracute 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 necrosisfactor 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 theycompleted the study up to and including visit 7. Exclusion:

• Continuation in this extension study was considered inappropriate by the treatingphysician. Extension Study 2: Inclusion Criteria:

• Completion of the first extension study CACZ885H2357E1. A patient was defined ascompleting the first extension study if they completed the study up to and includingVisit 10). Exclusion Criteria:

-Continuation in this second extension study was considered inappropriate by the treatingphysician. Other protocol-defined inclusion-exclusion criteria applied to the core and extensionstudies.