Status:
COMPLETED
Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Familial Cold Autoinflammatory Syndrome (FCAS)
Familial Cold Urticaria
Eligibility:
All Genders
7+ years
Phase:
PHASE3
Brief Summary
Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1). These mutation...
Detailed Description
Primary Objective: The primary objective of this study was to assess the effect of rilonacept on the clinical signs and symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) when used for chronic...
Eligibility Criteria
Inclusion
- Double-blind phases: adults age 18 and above; Open-label extension: Adults and children aged 7 years and older.
- Was diagnosed with Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS) based upon clinical signs and symptoms
- Had documented mutation in NLRP-3 (Cold Induced Autoinflammatory Syndrome-1 or CIAS1) in subject or relative, and willingness to have a confirmatory genetic (Deoxyribonucleic acid or DNA) test (cheek swab).
- Was able to understand and comply with study procedures and was able to provide informed consent
- If female, was not currently pregnant and was willing to use contraception during the study
Exclusion
- Had evidence of untreated tuberculosis or other conditions/therapies that made the subject inappropriate for this study.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00288704
Start Date
December 1 2005
End Date
August 1 2008
Last Update
December 6 2011
Active Locations (24)
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1
Little Rock, Arkansas, United States, 72204
2
Palm Desert, California, United States, 92260
3
Upland, California, United States, 91786
4
Jacksonville, Florida, United States, 32216