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Clinical Trials/PER-065-13
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)

BRISTOL MYERS SQUIBB COMPANY,0 sites9 target enrollmentStarted: February 17, 2014Last updated:

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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