A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis

This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).

Inclusion criteria:

• Adult patients 18-80 years of age.

• Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.

• Receiving outpatient treatment for RA.

• Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.

• At screening, either

  • C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or
  • Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour.

• Inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.

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 or planned within 24 weeks of randomization.
• Previous treatment with any approved or investigational biological agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.