Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Last updated: July 29, 2008
Sponsor: Chugai Pharmaceutical
Overall Status: Completed

Phase

3

Condition

Arthritis And Arthritic Pain (Pediatric)

Joint Injuries

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT00144599
MRA316JP
  • Ages 2-19
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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"

Study Design

Total Participants: 56
Study Start date:
May 01, 2004
Estimated Completion Date:
October 31, 2005