This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
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
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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