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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
8mg/kg/2weeks
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
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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