NCT01803321

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

A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 4 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Systemic Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	rilonacept (IL-1 Trap)
OTHER	Placebo

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2013-03-04
• Last updated: 2013-03-04

Locations

9 sites across 1 country: United States