Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares



Status:Completed
Conditions:Gout
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:November 2011
End Date:June 2013
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com

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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares


The purpose of this study is to determine the safety and tolerability of rilonacept for
patients with gout who are initiating allopurinol.


Inclusion Criteria:

Key Inclusion criteria:

- Male or female patients aged 18 to 80 years

- Previously met the preliminary criteria of the ARA for the classification of the
acute arthritis of primary gout

- Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit

- A self-reported history of at least 2 gout flares in the year prior to screening

Exclusion Criteria:

Key Exclusion criteria:

- Pregnant or nursing, or planning to become pregnant or father a child within 3 months
after receiving the last dose of study drug

- Patients requiring dialysis

- Patients who have had an organ transplant

- Persistent chronic or active infections

- Previous exposure to rilonacept

- Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84
days prior to the Screening Visit
We found this trial at
29
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Washington,
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Ashville, NC
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Charleston, South Carolina 29412
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