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)
1 other identifier
interventional
24
1 country
9
Brief Summary
This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2005
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 28, 2013
CompletedFirst Posted
Study publicly available on registry
March 4, 2013
CompletedMarch 4, 2013
February 1, 2013
2.6 years
February 28, 2013
February 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of treatment emergent adverse events (TEAEs)
Baseline to Week 123
Study Arms (2)
Cohort 1
EXPERIMENTALDose 1
Cohort 2
EXPERIMENTALDose 2
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of certain medications prior to the baseline visit
- History of recurrent infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Wilmington, Delaware, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Hackensack, New Jersey, United States
Unknown Facility
Long Island City, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Seattle, Washington, United States
Related Publications (1)
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.
PMID: 23754188DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2013
First Posted
March 4, 2013
Study Start
November 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
March 4, 2013
Record last verified: 2013-02