Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Chugai Pharmaceutical |
---|---|
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
|
2: Experimental |
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumabu 50mg
Intravenous repeating dose (50mg)
|
3: Experimental |
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumabu 200mg
Intravenous repeating dose (200mg)
|
4:: Experimental |
Drug: methotrexate
Oral repeating dose
Drug: ocrelizumab 500mg
Intravenous repeating dose (500mg)
|
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 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Folic Acid Antagonists |
Immunosuppressive Agents Folic Acid Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |