Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout

This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Inclusion Criteria:

• score over 50 on the 0-100 VAS pain scale
• acute, confirmed gout flare for no longer than 3 days

Exclusion Criteria:

• Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
• Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
• Pregnant or breastfeeding women
• Major surgery with high infection risk
• History of severe allergy to food or drugs
• History or risk of tuberculosis
• Active infection

Other protocol-defined inclusion/exclusion criteria may apply