CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
rilonacept 160 mg +2 moredrug
Likely dose
rilonacept 160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00288704
NCT00288704Phase 3Completed
CompareCT.gov

IL1T-AI-0505: A Multi-center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, & Efficacy of Rilonacept in Subjects With Cryopyrin-Associated Periodic Syndromes (CAPS) Using Parallel Group & Randomized Withdrawal Designs

Regeneron Pharmaceuticals·interventional·Posted Feb 8, 2006·Updated Dec 6, 2011

In Brief

A Phase 3 clinical trial evaluating rilonacept 160 mg and Placebo for Familial Cold Autoinflammatory Syndrome (FCAS) and 3 related conditions. Completed, enrolled 104 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria, Muckle-Wells Syndrome (MWS), Genetic Diseases, Inborn
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2006
Enrollment StartDec 1, 2005
Primary CompletionJun 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.4 years ago

Interventions

rilonacept 160 mgdrug

Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. On Day 1, subjects received two injections of rilonacept (for a total of 320 mg).

Placebodrug

Subcutaneous injection of Placebo occurred during first 6 weeks of the study or during randomized withdrawal (weeks 15-24). On Day 1, subjects received two placebo injections.

rilonacept 160 mgdrug

Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. No loading dose was given for subjects who entered directly into the open-label.