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.
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Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS)
Timeframe: Baseline (Days -21 to -1) and Week 6 (Days 21-42)
Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B)
Timeframe: Week 15 through Week 24 (randomized withdrawal)