Document Classification

Section Type: OBJECTIVE

Text: To determine the optimal dose regimen of intravenous (IV) Ro 45-2081 (lenercept), a tumor necrosis factor receptor p55-Fc IgG1 fusion protein, in patients with active rheumatoid arthritis (RA) METHODS : In a double-blind, placebo-controlled, parallel-group, multicenter trial, adult patients with long-standing active RA stabilized on conventional therapy were randomly assigned to receive 3 IV infusions, one every 4 weeks, of one of the following : (a) placebo, (b) lenercept 0. 01 mg/kg (maximum 1 mg), (c) lenercept 0. 05 mg/kg (maximum 5 mg), (d) lenercept 0. 2 mg/kg (maximum 20 mg), or (e) lenercept 0. 5 mg/kg (maximum 50 mg).