A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

• Status: Terminated
• Trial end date: 2012-11-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Adalimumab; Etanercept; Infliximab; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Ocrelizumab; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age >= 18 years

• Current treatment for RA on an outpatient basis

• Active disease

• Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.

• Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons

Exclusion Criteria:

• Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA

• History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)

• Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab

• Treatment with more than one prior anti-TNFα therapy