Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Sponsor: Chugai Pharmaceutical
Study ID: NCT00144612
Phase: PHASE3
Status: Completed

Conditions

Systemic Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex: ALL
Age: 2 Years - 19 Years
Healthy Volunteers: Not accepted

Interventions

MRA(Tocilizumab) — DRUG
8mg/kg/2weeks

Study Details

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Key Dates

Start date: Jul 31, 2004
Status verified: Dec 2009
Primary completion: Jun 30, 2005
Completion: Jun 30, 2009

Study Design

Enrollment: 60 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 compared with before the first infusion of the investigational product (including the previous study) [ Time Frame: whole period ]