The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
14
100mg/vial
100mg/vial
392001001
Sendai, Miyagi, Japan
Safety : Incidence of Adverse Events
Time frame: 14 weeks
PK : Area under the serum concentration versus time curve(AUC)
Time frame: 14 weeks
Efficacy : ACR core-set
Time frame: 14 weeks
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