This is a multicenter, double-blind, randomized clinical study of safety, tolerability, pharmacokinetics and pharmacodynamics of biosimilar drug Ritumax® compared to original drug MabThera® in patients with rheumatoid arthritis, receiving stable doses of Methotrexate. At Week -2, after signing the Patient Information Sheet and Informed Consent Form, patients with rheumatoid arthritis receiving stable doses of Methotrexate (10-25 mg per week orally or parenterally) will pass screening procedures. Patients meeting all the inclusion/exclusion criteria will be invited to the investigational site for Visit 2 (Week 0) to be randomized into one of two treatment arms: * Ritumax® 1000 mg х 2 intravenous infusions * MabThera® 1000 mg х 2 intravenous infusions After being assigned to the treatment arm patients will receive a course of study treatment, including two i/v infusions at 14-day interval: at Week 0 and Week 2. After that, patients will be followed up for the next 22 weeks. Safety, pharmacokinetic and pharmacodynamic parameters will be monitored at this visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
1000 mg intravenously
1000 mg intravenously
Federal State Budgetary Institution "Scientific Research Institution of Rheumatology" Russian Academy of Medical Sciences (FSBI "SRIR" RAMS)
Moscow, Russia
Area under the plasma concentration versus time curve (AUC)
Comparative assessment of pharmacokinetic parameters of Ritumax® and MabThera
Time frame: within a 24-week period
Peak Plasma Concentration (Cmax)
Comparative assessment of pharmacokinetic parameters of Ritumax® and MabThera
Time frame: within a 24-week period
CD19+ B- lymphocytes
Comparative assessment of pharmacodynamic parameters of Ritumax® and MabThera®
Time frame: within a 24-week period
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
The number of patients with treatment-related AEs
Time frame: within a 24-week period
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