Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis

Exclusion Criteria

• •A history of rheumatic autoimmune disease other than rheumatoid arthritis.
• •Functional Class IV according to the ACR Functional Status Classification or wheelchair/bedridden.
• •Development of pronounced extra-articular (systemic) manifestations of the disease and complications (rheumatoid vasculitis, amyloidosis, Felty's syndrome, neuropathy, damage to the organ of vision).
• •Use of oral corticosteroids in doses greater than \>10 mg daily prednisolone equivalent, or change in oral corticosteroid dose within 4 weeks before or during screening.
• •Use of injectable corticosteroids (including intra-articular corticosteroids) or intra-articular hyaluronic acid injections within 4 weeks before or during screening.
• •Therapy with tumor necrosis factor-alfa (TNF-alpha) inhibitors or any other genetically engineered biological drugs within 1 month before screening.
• •History of tocilizumab therapy.
• •Major surgery (including joint surgery) within 8 weeks before the start of the study or elective surgery within 6 months after the start of the study.
• •A history of an adverse drug reaction to any of the components of the study drug or a reference drug.
• •Immunization with any live or live attenuated vaccine within 1 month before the first dose of the study or comparator drug.
• •A history of a disease associated with the accumulation of immune complexes (including serum sickness).
• •Concomitant diseases and conditions that, in the opinion of the Investigator and/or Sponsor, jeopardize the safety of the patient during participation in the study, or which will influence the analysis of safety data.
• •Active systemic infection (bacterial, viral or fungal) within 14 days before signing the informed consent form or at the time of screening.
• •Blood donation or blood loss (450 ml of blood or more) less than 2 months before the start of the study.
• •Pregnancy or breastfeeding.
• •History of demyelinating disease of the central nervous system.
• •History of diverticulosis/intestinal diverticulitis or chronic ulcerative diseases of the lower gastrointestinal tract, such as Crohn's disease, ulcerative colitis.
• •History of tuberculosis.
• •Positive/doubtful test with tuberculosis allergen.
• •Participation in clinical trials of drugs less than 3 months before signing the informed consent form.
• •Positive tests for hepatitis B or C, HIV or syphilis.
• •Unwillingness or inability to comply with the recommendations prescribed by this protocol.
• •Identification during screening of other diseases/conditions not listed above that, in the opinion of the physician-researcher, prevent the inclusion of the patient in the study.