Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
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...
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”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: October 2008
Intervention(s) in this Clinical Trial
- Biological: rilonacept
- 160mg sc once a week
- Other: placebo
- placebo sc once a week
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- rilonacept
- Placebo Comparator: 2
- placebo
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 Investigator Information
Lead Investigator: Regeneron Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Shirletta King-Davis Study Director Regeneron Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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 content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00610363
