Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Phase 3
Completed
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Drug: MRA(Tocilizumab)Drug: placebo
- Registration Number
- NCT00144599
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MRA(Tocilizumab) - 2 placebo -
- Primary Outcome Measures
Name Time Method Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS open-label period Efficacy:Percentage of patients in whom effects were maintained Blind period Safety:Incidence and severity of adverse events and adverse drug reactions whole period Pharmacokinetics:The time course of the trough serum MRA concentration whole period
- Secondary Outcome Measures
Name Time Method Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score Open-label period Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS Blind Period