Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Phase 1

Completed

• Conditions: Systemic Juvenile Idiopathic Arthritis
• Interventions: Drug: rilonacept (IL-1 Trap); Other: Placebo

• Registration Number: NCT01803321
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2013-02
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-02-28
• Last Update Submitted: 2013-02-28
• Study First Posted: 2013-03-04
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 2	Placebo	Dose 2
Cohort 1	rilonacept (IL-1 Trap)	Dose 1
Cohort 1	Placebo	Dose 1
Cohort 2	rilonacept (IL-1 Trap)	Dose 2

Primary Outcome Measures

Name	Time	Method
Frequency of treatment emergent adverse events (TEAEs)	Baseline to Week 123