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 Jun 2018

At a glance

  • Drugs Adalimumab (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).
    • 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.
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