Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease

The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).

Inclusion criteria:

• Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
• Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
• Onset of current acute gouty arthritis flare within 3 days prior to randomization

Exclusion criteria:

• Hemodialysis CKD Stage 5 Organ transplantation
• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
• Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply