A Clinical Trial to measure the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate reduction Therapy.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Gout
- Registration Number
- CTRI/2009/091/001045
- Lead Sponsor
- Regeneron Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1200
Inclusion Criteria
Male or female 18 to 80 years of age
-Previously met the preliminary criteria of ARA for the classification of acute gout arthritis of primary gout
-Subjects with history of gout, initiating or currently on urate lowering therapy who are at risk of gout flare
Exclusion Criteria
-Acute gout flare within 2 weeks prior to the Screening Visit and during the screening visit
-Persistent chronic or active infections
-History of an allergic reaction to allopurinol or other urate lowering therapy
-History or presence of cancer within 5 years of the Screening Visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessed by summarizing the incidences and types of treatment-emergent adverse events and changes in laboratory parametersTimepoint: changes in laboratory parameters
- Secondary Outcome Measures
Name Time Method The number of gout flares from Day 1 to Week 16 <br/ ><br>The proportion of subjects with one or more gout flares from Day 1 to Week 16 <br/ ><br>The proportion of subjects with at least two flares from Day 1 to Week 16 <br/ ><br>The number of gout flare days from Day 1 to Week 16 <br/ ><br>Timepoint: The number of gout flare days from Day 1 to Week 16 <br/ ><br>