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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: Chugai Pharmaceutical

Criteria

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