Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

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

Summary

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

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

Details

• Lead Sponsor: Chugai Pharmaceutical

Criteria

Inclusion criteria

• Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)

• Patients between 2 and 19 years of age

• Patients who are under 16 years of age at onset

• Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions

Exclusion criteria

• Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product

• Patients who have received the following treatments within 4 weeks before treatment with the investigational product

1. Surgical treatment (e.g., operation)

2. Plasma exchange therapy"