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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: Hoffmann-La Roche
• Treatments: Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

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.