NCT04079374

Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel

Open, Randomized, Comparative, Multicenter Study in Parallel Groups of the Efficacy, Safety, Immunogenicity of Etanercept and Enbrel, Lyophilisates for Solution for Subcutaneous Injection, in Patients With Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Joint Stock Company "Farmak" · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, randomized, comparative, multicentre study in parallel groups of the efficacy, safety and immunogenicity of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection, in patients with rheumatoid arthritis. Total duration of patient participation in the study will be 49-52 weeks. Of these: screening - up to 4 weeks, treatment - 24 weeks, follow-up after treatment - 4 weeks, evaluation of the study drug immunogenicity - 52 weeks after the treatment initiation. Patients receive Etanercept or Enbrel (depending on the group) in the form of subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Etanercept	Subcutaneous injections
DRUG	Enbrel	Subcutaneous injections

Timeline

• Start date: 2018-09-03
• Primary completion: 2021-12-03
• Completion: 2023-12-03
• First posted: 2019-09-06
• Last updated: 2021-02-03

Locations

10 sites across 1 country: Ukraine