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) Revised Protocol 03 incorporating Amendment 11

Bristol-Myers Squibb International Corporation0 个研究点目标入组 210 人开始时间: 2013年11月14日最近更新: 2015年3月16日

试验速览

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•1.JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response (for at least 3 months) or prior or intolerance to at least one non biologic DMARD or TNFa antagonists
•2. Subjects with TNFa inadequate response (or prior biologic) will be restricted to 30% of the population
•3. 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 210
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. 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 TNFa antagonists or other biological DMARDS will be excluded.
•(Subjects with enthesitis related arthritis or psoriatic arthritis (PsA) can be included)
•2. Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
•3. Subjects who have failed more than two TNFa antagonists or other biologic DMARDs

发起方