Back to resultsStudy to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Primary Purpose
Systemic Juvenile Idiopathic Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rilonacept (IL-1 Trap)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Juvenile Idiopathic Arthritis focused on measuring SJIA
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Dose 1
Dose 2
Outcomes
Primary Outcome Measures
Frequency of treatment emergent adverse events (TEAEs)
Secondary Outcome Measures
Full Information
NCT ID
NCT01803321
First Posted
February 28, 2013
Last Updated
February 28, 2013
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01803321
Brief Title
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Juvenile Idiopathic Arthritis
Keywords
SJIA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Dose 2
Intervention Type
Drug
Intervention Name(s)
rilonacept (IL-1 Trap)
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Frequency of treatment emergent adverse events (TEAEs)
Time Frame
Baseline to Week 123
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Wilmington
State/Province
Delaware
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Long Island
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23754188
Citation
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.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
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