PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.

Inclusion Criteria:

• Male or female 18 to 80 years of age;
• Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification of the acute arthritis of primary gout;
• At least 2 gout flares in the year prior to the screening visit;
• Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit.

Exclusion Criteria:

• Acute gout flare within 2 weeks of the screening visit or during screening;
• Persistent chronic or active infections;
• History of an allergic reaction to allopurinol;
• History or presence of cancer within 5 years of the screening visit;
• Previous exposure to Rilonacept;
• Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.