This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
8mg/kg/4 weeks
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
Time frame: throughout study
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
Time frame: throughout study
Pharmacokinetics of the serum MRA concentration
Time frame: 0W,4W,8W,12W,LOBS
Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
Time frame: 0W,4W,8W,12W,LOBS
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