Status:
COMPLETED
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Active Polyarticular Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
Eligibility Criteria
Inclusion
- JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening
- Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population
- Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.
Exclusion
- Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.
- Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
- Subjects who have failed more than two TNFα antagonists or other biologic DMARDs
Key Trial Info
Start Date :
August 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01844518
Start Date
August 30 2013
End Date
February 1 2023
Last Update
July 12 2023
Active Locations (57)
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1
Local Institution - 0007
Birmingham, Alabama, United States, 35233-1711
2
Local Institution - 0003
Little Rock, Arkansas, United States, 72202
3
Local Institution - 0011
Hartford, Connecticut, United States, 06106
4
Local Institution - 0009
Chicago, Illinois, United States, 60637