Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
NCT ID: NCT01803321
Last Updated: 2013-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2005-11-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
Dose 1
rilonacept (IL-1 Trap)
Placebo
Cohort 2
Dose 2
rilonacept (IL-1 Trap)
Placebo
Interventions
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rilonacept (IL-1 Trap)
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* History of recurrent infections
4 Years
20 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Los Angeles, California, United States
Wilmington, Delaware, United States
Chicago, Illinois, United States
Hackensack, New Jersey, United States
Long Island City, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dallas, Texas, United States
Seattle, Washington, United States
Countries
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References
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Lovell DJ, Giannini EH, Reiff AO, Kimura Y, Li S, Hashkes PJ, Wallace CA, Onel KB, Foell D, Wu R, Biedermann S, Hamilton JD, Radin AR. Long-term safety and efficacy of rilonacept in patients with systemic juvenile idiopathic arthritis. Arthritis Rheum. 2013 Sep;65(9):2486-96. doi: 10.1002/art.38042.
Other Identifiers
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IL1T-AI-0504
Identifier Type: -
Identifier Source: org_study_id
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