Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
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Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study) [ Time Frame: whole period ]
Safety:Incidence and severity of adverse events and adverse reactions [ Time Frame: whole period ]
Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ]
Secondary Outcome Measures :
Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ]
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Layout table for eligibility information
Ages Eligible for Study:
2 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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