At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,315 enrolled
Drug / intervention
Rilonacept +1 morebiological
Likely dose
Rilonacept 160 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.
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy
In Brief
A Phase 3 clinical trial evaluating Rilonacept and Placebo for Gout. Completed, enrolled 1,315 participants across 124 sites in 6 countries.
Detailed Summary
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesGermany, India, Indonesia, South Africa, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedMar 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedMar 5, 2009
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago
Interventions
Rilonaceptbiological
Rilonacept 160 mg subcutaneous injection once a week
Placeboother
Placebo subcutaneous injection once a week