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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00779220 |
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.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: placebo Drug: methotrexate Drug: ocrelizumabu 50mg Drug: ocrelizumabu 200mg Drug: ocrelizumab 500mg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy |
Estimated Enrollment: | 200 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: placebo
Intravenous repeating dose
Drug: methotrexate
Oral repeating dose
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2: Experimental |
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumabu 50mg
Intravenous repeating dose (50mg)
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3: Experimental |
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumabu 200mg
Intravenous repeating dose (200mg)
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4:: Experimental |
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumab 500mg
Intravenous repeating dose (500mg)
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Naritoshi Mochidome | clinical-trials@chugai-pharm.co.jp |
Japan | |
Chubu region | |
Chubu, Japan | |
Chugoku region | |
Chugoku, Japan | |
Hokkaido Region | |
Hokkaido, Japan | |
Sikoku region | |
Sikoku, Japan | |
Kinki Region | |
Kinki, Japan | |
Kyusyu region | |
Kyusyu, Japan | |
Kanto Region | |
Kanto, Japan |
Study Chair: | Naritoshi Mochidome | Chugai Pharmaceutical |
Responsible Party: | Chugai Pharmaceutical Co., Ltd. ( Naritoshi Mochidome ) |
Study ID Numbers: | JA21963 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779220 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Folic Acid Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |