Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

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

Phase

3

Condition

Arthritis And Arthritic Pain (Pediatric)

Joint Injuries

Rheumatoid Arthritis (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00144664
MRA318JP
  • Ages 2-19
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 19
Study Start date:
November 01, 2004
Estimated Completion Date:
October 31, 2005