Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
Status:
Recruiting
Trial end date:
2023-12-03
Target enrollment:
Participant gender:
Summary
The Study objectives are:
1. To compare the efficacy and safety of Etanercept, lyophilisate for solution for
injection and Enbrel, lyophilisate for solution for subcutaneous injection, which are
used as subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks in
combination with methotrexate in patients with rheumatoid arthritis.
2. To prove the therapeutic equivalence of Etanercept, lyophilisate for solution for
injection and Enbrel, lyophilisate for solution for subcutaneous injection in patients
with rheumatoid arthritis.
3. To evaluate the immunogenicity of Etanercept, lyophilisate for solution for injection.