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)
- Conditions
- -M008M008
- Registration Number
- PER-065-13
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
pJIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one biologic or non biologic DMARD for at least 3 months prior to screening. Subjects with TNFα inadequate response or other prior biologics 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.
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 more than two TNFα antagonists or other biological DMARDS will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method