Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Phase 3
Completed
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Drug: MRA(Tocilizumab)
- Registration Number
- NCT00144612
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MRA(Tocilizumab) -
- Primary Outcome Measures
Name Time Method Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study) whole period Safety:Incidence and severity of adverse events and adverse reactions whole period Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks 0 week and every 2 weeks
- Secondary Outcome Measures
Name Time Method Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks 0 week and every 2 weeks