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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00144599 |
This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.
Condition | Intervention | Phase |
---|---|---|
Systemic Juvenile Idiopathic Arthritis |
Drug: MRA(Tocilizumab) Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA |
Enrollment: | 56 |
Study Start Date: | May 2004 |
Study Completion Date: | October 2005 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: MRA(Tocilizumab) |
2: Placebo Comparator | Drug: placebo |
Ages Eligible for Study: | 2 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Patients who have received the following treatments within 4 weeks before treatment with the investigational product
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | MRA316JP |
Study First Received: | September 2, 2005 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00144599 |
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 |