NCT00829829

PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.

Conditions

• Intercritical Gout

Interventions

Type	Name	Description
OTHER	Placebo	Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.
DRUG	Rilonacept 80 mg	Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
DRUG	Rilonacept 160 mg	Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2009-01-27
• Last updated: 2017-04-28
• Results posted: 2017-04-28

Locations

91 sites across 2 countries: United States, Canada