Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Phase 3
Completed
- Conditions
- Polyarticular Juvenile Idiopathic Arthritis
- Interventions
- Drug: MRA(Tocilizumab)
- Registration Number
- NCT00144625
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.
- 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) -
- Primary Outcome Measures
Name Time Method Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS every 3 months Safety:Incidence and severity of adverse events and adverse drug reactions whole period Pharmacokinetics:The time course of the trough values for the 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 variable of the JIA core set, CRP, pain every 3M, LOBS every 3 months