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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

• number of flares during the treatment period
  • Time Frame: 16 weeks
    Safety Issue?: Yes

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

Lead Sponsor: Regeneron Pharmaceuticals

Information obtained from ClinicalTrials.gov on July 02, 2009

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