PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1

Completed · Phase 3 · Has a placebo group

Conditions studied: Intercritical Gout

In brief

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 gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.

Key facts

Study ID

NCT00829829

Run by

Regeneron Pharmaceuticals

People needed

241

Starts

2009-02-01

Expected to finish

2010-06-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Study site — Gilbert, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Searcy, Arkansas, United States
• Study site — Concord, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Maria, California, United States
• Study site — Trumball, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Naples, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Gainsville, Georgia, United States
• Study site — Rome, Georgia, United States
• Study site — Tucker, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Avon, Indiana, United States
• Study site — Evansville, Indiana, United States
• Study site — South Bend, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Bowling Green, Kentucky, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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