Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Last updated: December 21, 2009
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

NCT00144612
MRA317JP
  • Ages 2-19
  • All Genders

Study Summary

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Eligibility Criteria

Inclusion

Inclusion criteria (MRA011JP patients)

  • Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period

  • the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)

  • Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal

  • Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

Exclusion criteria

  • Patients who were not enrolled by 3 months after completion of the previous study

  • Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

Study Design

Total Participants: 60
Study Start date:
July 01, 2004
Estimated Completion Date:
June 30, 2009