Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical

Criteria

Inclusion criteria

• Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)

• Patients aged at least 2 years old and less than 20.

• Patients aged less than 16 years old at time of onset

Exclusion criteria

• Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product

• Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product