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: 26 Sep 2017

At a glance

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

    • 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.
    • 24 Aug 2017 According to Biogen media release, based on the data from preclinical and clinical data from this and other phase I study (NCT02144714), the European Commission (EC) granted a marketing authorization for IMRALDI for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis and uveitis.
    • 17 Jun 2017 Results of subgroup analyses of efficacy by adalimumab serum trough concentration (Ctrough) and association between anti-drug antibodies (ADA) and Ctrough, presented at the 18th Annual Congress of the European League Against Rheumatism.
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