At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years
- ✓Previously met ARA preliminary criteria for acute arthritis of primary gout
- ✓Acute gout flare within 48 hours of pain onset with at least moderate severity
- ✓Gouty index joint with swelling and/or tenderness score ≥1 on 0-3 scale
- ✕NSAID or opiate use within 48 hours prior to baseline
- ✕Long-acting NSAID use within 1 month prior to baseline
- ✕Naproxen, meloxicam, nabumetone, celecoxib, or indomethacin SR within 5 days prior to baseline
- ✕Oral analgesic use within 6 hours before baseline assessments
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Rilonacept, Indomethacin, and 2 other interventions for Acute Gout Flare. Completed, enrolled 225 participants across 44 sites.
Detailed 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.
Study Details
Timeline
Interventions
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Placebo (for Indomethacin) orally TID for 12 days.
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).