NCT01459796

Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Rilonacept	Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
DRUG	Placebo	Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
DRUG	Allopurinol	Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-10-26
• Last updated: 2017-07-18
• Results posted: 2017-07-18

Locations

74 sites across 1 country: United States