PER-065-13Recruiting未知
A PHASE 3 MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE 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)
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Enrollment
- 9
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 6 to 17 (—)
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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