We are conducting a double-masked controlled randomized (Phase I) and open label pilot study (Phase II) study to describe the efficacy of TNFR:Fc (Etancercept, Enbrel) in the treatment of uveitis associated with Juvenile Rheumotoid Arthritis and also to provide limited safety information on the possible therapeutic activity of TNFR:Fc. Children between the ages of 2 and 18 years who meet the American College of Rheumatology criteria for Juvenile Rheumatoid Arthritis and have active anterior uveitis have been eligible for the study. Patients receive either the Enbrel or placebo twice weekly at a dose of 0.4 mg/kg. Patients who complete the masked Phase I portion of the protocol are eligible to participate in the open label Phase II portion of the study. We have recently closed enrollment on the study and are completing the followup evaluations. The data have been analyzed and the publication is in preparation.
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Smith, Janine A; Thompson, Darby J S; Whitcup, Scott M et al. (2005) A randomized, placebo-controlled, double-masked clinical trial of etanercept for the treatment of uveitis associated with juvenile idiopathic arthritis. Arthritis Rheum 53:18-23 |