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: 23 Jun 2017

At a glance

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

    • 23 Jun 2017 According to Biogen media release, based on the data from preclinical and clinical data from this and other phase III study (NCT02167139), the CHMP of the European Medicines Agency (EMA) has issued a positive opinion for IMRALDI. The positive opinion will now be referred to the European Commission (EC) for marketing authorization in the European Union.
    • 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.
    • 17 Jul 2016 According to Biogen media release, the Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira, has been accepted for review by the European Medicines Agency (EMA) based upon the data from preclinical and clinical data from this and other phase I study (NCT02144714).
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