Status:
TERMINATED
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study wil...
Detailed Description
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active RA. The data from this study will also be compared with those from a...
Eligibility Criteria
Inclusion
- Diagnosis of RA for ≧6 months according to the revised 1987 ACR criteria for the classification of RA.
- Adult patients, ≧20 years of age.
- Receiving methotrexate at a dose of 6 to 8mg/week（oral）for ≧12 weeks, with a stable dose for the last 4 weeks before treatment.
- Positive serum RF.
Exclusion
- Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome).Patients with secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA are eligible.
- 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 autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
- Any surgical procedure (except for minor surgeries requiring local or no anaesthesia and without any complications or sequelae) within 12 weeks prior to or planned within 24 weeks after baseline.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00779220
Start Date
October 1 2008
End Date
March 1 2015
Last Update
March 25 2015
Active Locations (7)
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1
Chugoku region
Chugoku, Japan
2
Chubu region
Chūbu, Japan
3
Hokkaido Region
Hokkaido, Japan
4
Kanto Region
Kanto, Japan