Status:
COMPLETED
A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Genentech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects w...
Eligibility Criteria
Inclusion
- Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
- Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA
- Positive serum RF
- Current treatment for RA on an outpatient basis
- Contact your local site that is listed for more inclusion criteria
Exclusion
- Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
- Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome)
- Functional Class IV as defined by the ACR classification of functional status in 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 rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
- Contact your local site that is listed for more exclusion criteria
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00077870
Start Date
February 1 2004
End Date
December 1 2006
Last Update
September 3 2009
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