Study Utilizing Rilonacept in Gout Exacerbations

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Indomethacin; Rilonacept

Criteria

Inclusion Criteria:

1. Male or female 18 - 70 years of age

2. Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout

3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity

4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint

5. Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria:

1. 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.

2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments

3. History of NSAID intolerance

4. Participants with history of chronic, gouty arthritis