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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00144664 |
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
Condition | Intervention | Phase |
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Systemic Juvenile Idiopathic 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, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA |
Enrollment: | 19 |
Study Start Date: | November 2004 |
Study Completion Date: | October 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MRA(Tocilizumab)
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Drug: MRA(Tocilizumab) |
Ages Eligible for Study: | 2 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | MRA318JP |
Study First Received: | September 2, 2005 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00144664 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Autoimmune Diseases Arthritis, Juvenile Rheumatoid Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |