Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis

Male and Female 18-65 y.o. with body weight 50-120 kg

Patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit per ACR/EULAR 2019 criteria classification.

Moderate or severe active course of rheumatoid arthritis, which is defined as the fulfillment of all of the following conditions:

• ≥6 tender joints (based on a score of 68 joints) at screening and baseline; And
• ≥6 swollen joints (based on a score of 66 joints) at screening and at baseline; And
• level of C-reactive protein is not less than 10 mg/l or ESR is not less than 28 mm/hour at screening.

Positive result of the analysis for antibodies to cyclic citrullinated peptide (≥10 units/ml) and / or the presence of rheumatoid factor (≥ 20 units/ml) at screening (see section).

Received treatment for RA and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy;

Must have received MTX for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose 10-25 mg/week;