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 Polyarticular Juvenile Rheumatoid Arthritis

This is a multicenter, Phase III randomized, placebo-controlled study in which polyarticular JRA subjects who are either MTX treated or non-MTX treated will initially receive Adalimumab by subcutaneous injection every other week for a four-month open-label lead-in period. Subjects who respond to the open-label therapy will then be rolled over into the double-blind portion of the study and will be randomized to receive either adalimumab or placebo for an additional 32 weeks or until flare of disease, whichever is earlier. Subjects who experience disease flare during the double-blind portion of the study or subjects who complete 48 weeks of the study will be given the option to receive open-label treatment with adalimumab for an additional 44 weeks.

Official Title

Conditions

– Arthritis, Juvenile Rheumatoid

Study Type

Interventional

Study Design

Treatment

Further Details

Study Start

Eligibility & Criteria

Criteria – Subjects must have a diagnosis of Polyarticular JRA age 4 to 17 by the 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 BSA/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 NSAIDs. – Have not received other DMARDs including penicillamine, hydroxychloroquine, sulfasalazine, oral or injectable gold, cyclosporin; or IV immunoglobulin (IV Ig); or cytotoxic agents, for at least 4 weeks prior to receiving 1st dose of study drug. Subjects currently on one or more of these DMARDs must demonstrate active disease (defined above) prior to a minimum 4 weeks (28 days) washout of all DMARDs. – Subjects who are refractory to MTX after 3 months of treatment must demonstrate active disease (defined above) prior to enrollment in the open-label part of the trial. – Have not received an intra-articular glucocorticoid injection within 4 weeks (28 days) prior to enrollment into the study. – Have good venous access and stable hematocrit  24%. – All sexually active male and female study participants must be practicing adequate contraception. Post-pubertal females must have a negative serum pregnancy test no greater than 10 days prior to the first dose of study drug. 10. Parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject’s parent or legal guardian has had the opportunity to ask questions.

Total Enrolment

Contact Details

[1] Monika Miranda (973)-394-5514 (US Only) otherwise contact via email: monika.miranda@abbott.com