Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Completed · Phase 3 · Has a placebo group

Conditions studied: Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria, Muckle-Wells Syndrome (MWS), Genetic Diseases, Inborn

In brief

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 mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the interleukin-1 cytokine and prevent it from binding to its receptors in the body.

Key facts

Study ID

NCT00288704

Run by

Regeneron Pharmaceuticals

People needed

104

Starts

2005-12-01

Expected to finish

2008-08-01

Last updated by the study team

2011-12-06

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Had evidence of untreated tuberculosis or other conditions/therapies that made the subject inappropriate for this study.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Palm Desert, California, United States
• Study site — Upland, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Stuart, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Aurora, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Chesterfield, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Greer, South Carolina, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Waco, Texas, United States
• Study site — Cedar City, Utah, United States
• Study site — Forest, Virginia, United States
• Study site — Lakewood, Washington, United States

Full record on ClinicalTrials.gov

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