CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 248 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Placebo 2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00958438
NCT00958438Phase 3Completed
CompareCT.gov

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

Regeneron Pharmaceuticals·interventional·Posted Aug 13, 2009·Updated Apr 28, 2017

In Brief

A Phase 3 clinical trial evaluating Placebo and Rilonacept for Gout. Completed, enrolled 248 participants across 61 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesGermany, India, Indonesia, South Africa, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2009
Enrollment StartJul 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.9 years ago

Interventions

Placebodrug

Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.

Rilonaceptdrug

Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.

Rilonaceptdrug

Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.