Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
- Sponsor
- Chugai Pharmaceutical
- Study ID
- NCT00144625
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 19 Years
- Healthy Volunteers
- Not accepted
Interventions
- MRA(Tocilizumab) — DRUG8mg/kg/4weeks
Study Details
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.
Key Dates
- Start date
- Feb 28, 2005
- Status verified
- Dec 2009
- Primary completion
- Jul 31, 2005
- Completion
- Jun 30, 2009
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
Primary Outcome Measure
Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS [ Time Frame: every 3 months ]