Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®

Exclusion Criteria

• •1. Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
• •2. A history of severe hypersensitivity reactions of any etiology.
• •3. Other (other than plaque) forms of psoriasis.
• •4. Drug-induced psoriasis.
• •5. Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
• •6. The presence of Adalimumab antibodies.
• •7. Extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period.
• •8. Active or latent tuberculosis
• •9. Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma.
• •10. Any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured.
• •11. Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the screening period.
• •12. Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C, HIV.
• •13. Vaccination with live or attenuated vaccines within 8 weeks before the screening period.
• •14. Hepatic and/or renal insufficiency.
• •15. Pregnancy or lactation.