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
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2009
End Date:November 2012

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A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB

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.


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
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110
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