Status:
COMPLETED
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Intercritical Gout
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for go...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00829829
Start Date
February 1 2009
End Date
June 1 2010
Last Update
April 28 2017
Active Locations (91)
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1
Birmingham, Alabama, United States, 35294
2
Gilbert, Arizona, United States, 85296
3
Peoria, Arizona, United States, 85381
4
Searcy, Arkansas, United States, 72143