Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Allopurinol; Rilonacept

Criteria

Inclusion Criteria:

Key Inclusion criteria:

• Male or female participants aged 18 to 80 years;

• Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;

• Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;

• A self-reported history of at least 2 gout flares in the year prior to screening.

Exclusion Criteria:

Key Exclusion criteria:

• Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug;

• Participants requiring dialysis;

• Participants who had had an organ transplant;

• Persistent chronic or active infections;

• Previous exposure to rilonacept;

• Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the screening visit.