We conducted 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 received either the Enbrel or placebo twice weekly at a dose of 0.4 mg/kg. Patients who completed the masked Phase I portion of the protocol were eligible to participate in the open label Phase II portion of the study. The data have been analyzed and a paper describing the results of the study has been submitted for publication.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Intramural Research (Z01)
Project #
1Z01EY000381-03
Application #
6826922
Study Section
(LI)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2003
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