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 will be analyzed after completion of the final study visit by the final patient.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Intramural Research (Z01)
Project #
1Z01EY000381-01
Application #
6546724
Study Section
(LI)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2001
Total Cost
Indirect Cost
Name
U.S. National Eye Institute
Department
Type
DUNS #
City
State
Country
United States
Zip Code
Nikolov, Nikolay P; Smith, Janine A; Patronas, Nicholas J et al. (2006) Diagnosis and treatment of vasculitis of the central nervous system in a patient with systemic lupus erythematosus. Nat Clin Pract Rheumatol 2:627-33; quiz 634
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