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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00808210

Run by

Genentech, Inc.

People needed

28

Starts

2009-03-05

Expected to finish

2012-11-14

Last updated by the study team

2020-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Dr. Brigid Freyne, MD — Murrieta, California, United States
• Agilence Arthritis and Osteoporosis Medical Center, Inc. — Whittier, California, United States
• Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs — Colorado Springs, Colorado, United States
• RASF-Clinical Research Center — Boca Raton, Florida, United States
• Robert W. Levin MD - PP — Dunedin, Florida, United States
• Science and Research Institute, Inc. — Jupiter, Florida, United States
• Rheumatology Associates of Central Florida — Orlando, Florida, United States
• Lovelace Scientific Resources — Sarasota, Florida, United States
• Arthritis Res & Treatment — Macon, Georgia, United States
• Harbin Clinic — Rome, Georgia, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• Illinois Bone & Joint Inst. — Morton Grove, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Hurley Medical Center — Flint, Michigan, United States
• Rheumatology, P.C.; Medical Arts Building — Kalamazoo, Michigan, United States
• Fiechtner Research Inc — Lansing, Michigan, United States
• Shores Rheumatology — Saint Clair Shores, Michigan, United States
• Jackson Arthritis Clinic — Flowood, Mississippi, United States
• Arthritis Associates of Mississippi — Jackson, Mississippi, United States
• Private Practice - Rosenberg — Florissant, Missouri, United States
• Rheumatology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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