Study Utilizing Rilonacept in Gout Exacerbations

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Gout Flare

In brief

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Key facts

Study ID

NCT00855920

Run by

Regeneron Pharmaceuticals

People needed

225

Starts

2009-03-01

Expected to finish

2010-02-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 18 - 70 years of age
• Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
• Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
• Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
• Current presentation of acute gout flare in 3 joints or less

You may not qualify if…

• Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.
• Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
• History of NSAID intolerance
• Participants with history of chronic, gouty arthritis

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Burbank, California, United States
• Study site — Whittier, California, United States
• Study site — Clearwater, Florida, United States
• Study site — DeBary, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Orange Park, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Oviedo, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Elizabethtown, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Wheaton, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Stevenville, Michigan, United States
• Study site — Billings, Montana, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albany, New York, United States
• Study site — Burlington, North Carolina, United States
• Study site — Cary, North Carolina, United States

Full record on ClinicalTrials.gov

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