Status:
COMPLETED
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Systemic Juvenile Idiopathic Arthritis
Eligibility:
All Genders
4-20 years
Phase:
PHASE1
Brief Summary
This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01803321
Start Date
November 1 2005
End Date
June 1 2008
Last Update
March 4 2013
Active Locations (9)
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1
Los Angeles, California, United States
2
Wilmington, Delaware, United States
3
Chicago, Illinois, United States
4
Hackensack, New Jersey, United States