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: 08 Nov 2017

At a glance

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

    • 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.
    • 08 Nov 2017 Results assessing the impact of the presence of anti drug antibody or injection site reaction on efficacy presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 19 Aug 2017 Results published in the Rheumatology
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