A Multicenter, Randomized, Double-blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Juvenile Rheumatiod Arthritis

Abbott Laboratories0 个研究点目标入组 171 人开始时间: 2012年2月7日最近更新: 2012年3月20日

适应症

试验速览

暂无简介。

•Subjects must have a diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) age 4 to 17 by the American College of Rheumatology (ACR) criteria. Disease onset may have been systemic, polyarticular, or pauciarticular. If the disease was systemic onset, then the subjects must be free of any systemic JRA manifestations for at least 3 months before the time of qualification.
•At the time of study screening, the subject must have continuing active disease defined as >= 5 swollen joints and >= 3 joints with limitation of motion (LOM). These joints are not mutually exclusive.
•Subjects may be either naïve to MTX, inadequate responders to MTX, or intolerant to MTX. Intolerance to MTX will be defined by the subject's physician. The MTX must be maintained at a dose of at least 10 mg/m2 body surface area/week for a minimum of 3 months, prior to screening.
•Duration of disease is not limited, but must have been long enough for a subject to have been given an adequate trial of nonsteroidal anti-inflammatory drugs (NSAIDs).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 171
•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

•Pregnant or nursing female.
•Functional class IV by ACR criteria.
•Laboratory parameters outside limits established in the protocol.
•Medical history, medical condition, or previous treatment not allowed by the protocol.

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