This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
Time frame: whole period
Safety:Incidence and severity of adverse events and adverse drug reactions
Time frame: whole period
Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration
Time frame: whole period
Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS
Time frame: whole period
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