NCT00855920

Study Utilizing Rilonacept in Gout Exacerbations

A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Gout Flare

Interventions

Type	Name	Description
DRUG	Rilonacept	Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
DRUG	Indomethacin	Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
OTHER	Placebo (for Indomethacin)	Placebo (for Indomethacin) orally TID for 12 days.
OTHER	Placebo (for Rilonacept)	Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-03-05
• Last updated: 2017-04-28
• Results posted: 2017-04-28

Locations

44 sites across 1 country: United States