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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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2018

At a glance

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

    • 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).
    • 08 Nov 2017 Results assessing radiographic progression by different disease activity states, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
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