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

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP

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

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