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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00144521 |
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: MRA(Tocilizumab) Drug: MRA placebo Drug: MTX Drug: MTX placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA |
Enrollment: | 127 |
Study Start Date: | February 2004 |
Study Completion Date: | April 2006 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: MRA(Tocilizumab)
8mg/kg/4week(i.v.)for 24 weeks
Drug: MTX placebo
0mg/week(p.o.) for 24 weeks
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2: Active Comparator |
Drug: MRA placebo
0mg/kg/4week(i.v.) for 24 weeks
Drug: MTX
8mg/week(p.o.) for 24 weeks
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Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.
Received any of the following therapies in the 4 weeks preceding treatment with the study drug
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | MRA213JP |
Study First Received: | September 2, 2005 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00144521 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |