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, Percentage of patients showing improvement in CRP on LOBS [ Time Frame: open-label period ]
Efficacy:Percentage of patients in whom effects were maintained [ Time Frame: Blind period ]
Safety:Incidence and severity of adverse events and adverse drug reactions [ Time Frame: whole period ]
Pharmacokinetics:The time course of the trough serum MRA concentration [ Time Frame: whole period ]
Secondary Outcome Measures :
Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score [ Time Frame: Open-label period ]
Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS [ Time Frame: Blind Period ]
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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:
Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
Patients between 2 and 19 years of age
Patients who are under 16 years of age at onset
Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions
Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product
Patients who have received the following treatments within 4 weeks before treatment with the investigational product