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: 17 Jun 2017

At a glance

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

    • 17 Jun 2017 Results of post-hoc analysis presented at the 18th Annual Congress of the European League Against Rheumatism
    • 17 Jun 2017 Results presented at the 18th Annual Congress of the European League Against Rheumatism
    • 12 Sep 2016 According to Samsung Bioepis media release, company announced that BRENZYS - a biosimilar referencing Enbrel (etanercept), also known as SB4 - received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis.
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