In This SectionTexas Health Research & Education Institute
Disease or Condition
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Combination with Methotrexate Compared with Infliximab Plus Methotrexate in Patients with Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
The purpose of this study is to evaluate the efficacy and safety of an investigational medicine to treat patients diagnosed with Rheumatoid Arthritis who are not responding to their current medication treatment.
Patients must be 18 years or older.
Patients must have Rheumatiod Arthritis (RA).
Currently receiving 50 mg etanercept subcutaneously (SC) every week (including patients receiving 25 mg twice a week) or 40 mg adalimumab SC every other week AND not responding to either treatment.
Patients with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA.
Patients with a 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).
Patients with previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab.
Patients with treatment with more than one prior anti-TNFa therapy.