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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Rilonacept

Criteria

Inclusion Criteria:

• 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 Criteria:

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