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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Gout

In brief

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

Key facts

Study ID

NCT01459796

Run by

Regeneron Pharmaceuticals

People needed

220

Starts

2011-11-01

Expected to finish

2013-06-01

Last updated by the study team

2017-07-18

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Searcy, Arkansas, United States
• Study site — Concord, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Whittier, California, United States
• Study site — Denver, Colorado, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Venice, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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