Conditions: Acute Gout Flare
Keywords: Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout Flare
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 225
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). arm 2: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). arm 3: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.

Interventions: intervention 1: Rilonacept intervention 2: Indomethacin intervention 3: Placebo (for Indomethacin) intervention 4: Placebo (for Rilonacept)
Intervention descriptions: intervention 1: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline). intervention 2: Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). intervention 3: Placebo (for Indomethacin) orally TID for 12 days. intervention 4: Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).

Protocol document: