Overview

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

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Regeneron Pharmaceuticals
Treatments:
Rilonacept
Criteria
Inclusion Criteria include, but are not limited to, the following:

- Patients aged 4 to less than 21 years who meet the criteria for active SJIA

- Must have been on a stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) for
at least 4 weeks prior to the screening visit

Exclusion Criteria include, but are not limited to, the following:

- Use of certain medications prior to the baseline visit

- History of recurrent infections