Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

Completed · Phase 3 · Has a placebo group

Conditions studied: Gout

In brief

The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.

Key facts

Study ID

NCT00856206

Run by

Regeneron Pharmaceuticals

People needed

1315

Starts

2009-03-01

Expected to finish

2011-01-01

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 American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
• Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.

You may not qualify if…

• Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
• Persistent chronic or active infections;
• History of an allergic reaction to allopurinol;
• History or presence of cancer within 5 years of the Screening Visit;;;

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Burbank, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Upland, California, United States
• Study site — Brooksville, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — DeBary, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Canton, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Sandy Springs, Georgia, United States
• Study site — Stockbridge, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Brownsburg, Indiana, United States
• Study site — Evansville, Indiana, United States
• Study site — Greenfield, Indiana, United States
• Study site — Bowling Green, Kentucky, United States
• Study site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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