Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel assignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 durati...
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.
Tracking Information
- NCT #
- NCT04079374
- Collaborators
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Investigators
- Principal Investigator: Mykola Stanislavchuk, MD, PhD Vinnitsa Regional Clinical Hospital Named after N.I.Pirogov
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