Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate
Verified date | September 2009 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 with moderate to severe RA
Status | Completed |
Enrollment | 237 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Genentech, Inc. |
Genovese MC, Kaine JL, Lowenstein MB, Del Giudice J, Baldassare A, Schechtman J, Fudman E, Kohen M, Gujrathi S, Trapp RG, Sweiss NJ, Spaniolo G, Dummer W; ACTION Study Group. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of pati — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of ocrelizumab in subjects with moderate to severe RA | |||
Secondary | Pharmacokinetics of ocrelizumab | |||
Secondary | Pharmacodynamics of ocrelizumab | |||
Secondary | Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria |
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