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Sponsored by: |
Chugai Pharmaceutical |
---|---|
Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00144534 |
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: MRA (Tocilizumab) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Extension, Phase III Study to Evaluate the Long-Term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP |
Enrollment: | 115 |
Study Start Date: | June 2004 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: MRA (Tocilizumab)
8mg/kg/4 weeks
|
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | MRA215JP |
Study First Received: | September 2, 2005 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00144534 |
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 |