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

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

Summary

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.

• 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

• 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