A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis - NCT00779220-Chugoku - 001 (Clinical Trial 249232)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy249232.aspx
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| City: |
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Chugoku |
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Country:
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Japan |
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| Conditions: |
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Rheumatoid Arthritis |
| Purpose: |
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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 will also be compared with those from a clinical study of ocrelizumab
in patients with active RA that was conducted in the U.S.
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| Study summary: |
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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 clinical study of ocrelizumab in patients with active RA that was
conducted in the U.S. |
| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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. |
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| Study is available at: |
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Chugoku region
Chugoku
Japan
Primary Contact:
Naritoshi Mochidome
Email: Clinical-trials@chugai-pharm.co.jp
Secondary Contact:
Naritoshi Mochidome
Email: clinical-trials@chugai-pharm.co.jp |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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