Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
- Sponsor
- Chugai Pharmaceutical
- Study ID
- NCT00144664
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 19 Years
- Healthy Volunteers
- Not accepted
Interventions
- MRA(Tocilizumab) — DRUG
Study Details
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
Key Dates
- Start date
- Nov 30, 2004
- Status verified
- Jul 2008
- Primary completion
- Apr 30, 2005
- Completion
- Oct 31, 2005
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1MRA(Tocilizumab)
Primary Outcome Measure
Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS [ Time Frame: whole period ]