A Clinical Trial to Study the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
Phase 3
- Registration Number
- CTRI/2009/091/000832
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.777 Old Saw Mill River RoadTarrytown, NY 10591Telephone: +914 345 7400Fax : +914 347 2847
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Male or female 18 to 80 years of age
Previously met the preliminary criteria of the 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method