Rituximab therapy for refractory scleritis: Results of a phase I/II dose-ranging, randomized, clinical trial

Abstract

Objective: To determine whether rituximab, a monoclonal antibody against the B-lymphocyte antigen CD20, is effective in the treatment of refractory noninfectious scleritis.Design: Prospective, dose-ranging, randomized, double-masked phase I/II clinical trial.Participants: Twelve patients with noninfectious scleritis refractory to systemic corticosteroid and ≥1 other systemic immunosuppressive agent were enrolled from January 2007 to March 2010. Intervention: Subjects were randomly assigned to 500 (n = 5) or 1000 mg (n = 7) dosing arms of rituximab intravenous infusions (500 or 1000 mg), given at study days 1 and 15. Initial responders with breakthrough inflammation after study week 24 were o..