A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.

Inclusion criteria:

• Adult patients 18-80 years of age
• RA for ≥ 2 months;
• Receiving outpatient treatment
• Patients naive to, and considered to be candidates for, methotrexate treatment

Exclusion criteria:

• Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
• Inflammatory joint disease other than RA, or other systemic autoimmune disorder
• Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16
• Surgery within 12 weeks of study
• Previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy
• Concurrent treatment with any biologic agent or DMARD other than methotrexate