This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. Subjects will participate in this study for approximately 24 weeks. Rilonacept is being studied for use in preventing gout attacks in patients who have gout...
Date First Received: January 24, 2008
Last Updated: January 24, 2008
Verified by: Regeneron Pharmaceuticals, January 2008
Clinical Trial Phase: Phase 2 | Start Date: November 2007
Overall Status: Recruiting
Estimated Enrollment: 80
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. Subjects will participate in this study for approximately 24 weeks.
Rilonacept is being studied for use in preventing gout attacks in patients who have gout.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: September 2008
Intervention(s) in this Clinical Trial
- Biological: rilonacept
- 160mg once a week
Outcome Measures for this Clinical Trial
Primary Measures
- number of flares during the treatment period
- Time Frame: 16 weeks
Safety Issue?: Yes
- Time Frame: 16 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male or female greater than 18 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
Exclusion Criteria:
- Acute gout flare within 2 weeks of the Screening visit and 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Regeneron Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Overall Contact: Cyndy Hughes 505-286-8683 hughes.cynthial@kendle.com
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00610363
Study ID Number: IL1T-GA-0619
ClinicalTrials.gov Identifier: NCT00610363
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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