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A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

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Trial Profile

A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2021

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At a glance

  • Drugs Etanercept (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis

Most Recent Events

  • 08 Oct 2021 Results of meta-analysis of 3 randomized controlled trials (NCT01270997; NCT01895309 & NCT02357069) assessing efficacy and safety of etanercept biosimilars vs. etanercept originators in patients with active rheumatoid arthritis despite treatment with methotrexate, published in the International Journal of Clinical Pharmacology and Therapeutics.
  • 13 Jun 2018 Pooled analysis data from three phase 3 studies (NCT01895309,NCT01936181 and NCT02167139) presented in a Samsung Bioepis media release.
  • 13 Jun 2018 According to a Samsung Bioepis media release, pooled analysis data from three phase 3 studies (NCT01895309,NCT01936181 and NCT02167139) will be presented at the Annual European Congress of Rheumatology (EULAR 2018).

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