CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Rilonacept +1 morebiological
Likely dose
Rilonacept 320 mgfrom 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/NCT00610363
NCT00610363Phase 2Completed

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

Regeneron Pharmaceuticals·interventional·Posted Feb 7, 2008·Updated May 2, 2017

In Brief

A Phase 2 clinical trial evaluating Rilonacept and Placebo (for Rilonacept) for Gout. Completed, enrolled 83 participants across 34 sites.

Detailed Summary

This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2008
Enrollment StartNov 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.4 years ago

Interventions

Rilonaceptbiological

Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.

Placebo (for Rilonacept)other

Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.