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Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel

NCT04079374 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-02-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Etanercept

Subcutaneous injections

DRUG

Enbrel

Subcutaneous injections

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • Joint Stock Company "Farmak"

    lead INDUSTRY

Principal Investigators

  • Mykola Stanislavchuk, MD, PhD · Vinnitsa Regional Clinical Hospital Named after N.I.Pirogov

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2021-12-03
Completion
2023-12-03

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079374 on ClinicalTrials.gov