The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
324
ARTMEDI UPD s.r.o
Hostivice, Czechia
ACR50
Time frame: week 24
ACR
Time frame: week 12
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