A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis

Trial Profile

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2018

At a glance

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

    • 13 Feb 2018 Results (n=542) assessing efficacy and comparable safety results of SB5 and reference adalimumab (ADA) in patients with moderate to severe rheumatoid arthritis, were published in the Arthritis and Rheumatology.
    • 08 Nov 2017 Results presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
    • 26 Sep 2017 Results assessing efficacy, safety, tolerability, pharmacokinetics and immunogenicity of adalimumab biosimilar [SB5; Samsung Bioepis] compared to adalimumab in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy, were published in the Arthritis and Rheumatology.
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