Status:
TERMINATED
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
Lead Sponsor:
Genentech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 approxima...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00808210
Start Date
March 5 2009
End Date
November 14 2012
Last Update
November 6 2020
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Rheumatology Associates
Birmingham, Alabama, United States, 35205
2
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
3
Dr. Brigid Freyne, MD
Murrieta, California, United States, 92563
4
Agilence Arthritis and Osteoporosis Medical Center, Inc.
Whittier, California, United States, 90606