NCT00958438

PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

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: 248 (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 participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Placebo	Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
DRUG	Rilonacept	Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.
DRUG	Rilonacept	Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-08-13
• Last updated: 2017-04-28
• Results posted: 2017-04-28

Locations

61 sites across 5 countries: Germany, India, Indonesia, South Africa, Taiwan