Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Sponsor: Chugai Pharmaceutical
Study ID: NCT00144599
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
placebo — DRUG

Study Details

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Key Dates

Start date: May 31, 2004
Status verified: Jul 2008
Completion: Oct 31, 2005

Study Design

Enrollment: 56 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: 1
Placebo Comparator: 2

Primary Outcome Measure

Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS [ Time Frame: open-label period ]