Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Phase 3
Completed
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Drug: MRA(Tocilizumab)
- Registration Number
- NCT00144664
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
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) MRA(Tocilizumab)
- Primary Outcome Measures
Name Time Method Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS whole period Safety:Incidence and severity of adverse events and adverse drug reactions whole period Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration whole period
- Secondary Outcome Measures
Name Time Method Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS whole period