Intercritical Gout Clinical Trial
— PRE-SURGE1Official title:
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
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 beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
Status | Completed |
Enrollment | 241 |
Est. completion date | June 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Male or female 18 to 80 years of age - Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout - At least 2 gout flares in the year prior to the Screening Visit - Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit Exclusion Criteria: - Acute gout flare within 2 weeks of the Screening Visit or during Screening - Persistent chronic or active infections - History of an allergic reaction to allopurinol - History or presence of cancer within 5 years of the Screening Visit - Previous exposure to rilonacept - Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the Screening Visit |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Regeneron Pharmaceuticals |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of flares during the treatment period | 16 Weeks | Yes | |
Secondary | number of modified gout flares per subject from Day 1 to Week 16 | 16 Weeks | Yes | |
Secondary | proportion of subjects with at least one flare from Day 1 to Week 16 | 16 Weeks | Yes | |
Secondary | proportion of subjects with at least two flares from Day 1 to Week 16 | 16 Weeks | Yes | |
Secondary | mean number of gout flare days per subject assessed from Day 1 to Week 16 | 16 Weeks | Yes | |
Secondary | mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 | 16 Weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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