The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.
Subjects who meet the criteria for participation in this study receive 2 intravenous infusions of MabionCD20® or MabThera® with two weeks interval in combination with methotrexate and folic acid. After the treatment period, patients are followed for 24 weeks, in order to continue checking safety. Therefore, the total study lasts 48 weeks. There is a possibility to repeat treatment after 6 months of the first infusions if subject meets the retreatment criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
709
Percentage of patients in each treatment group achieving the primary efficacy endpoint of a ≥ 20% improvement on the American College of Rheumatology score (ACR20) at Week 24.
Time frame: 24 weeks
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