A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate

Trial Profile

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms ARABESC
  • Sponsors Fujifilm Kyowa Kirin Biologics
  • Most Recent Events

    • 17 Jun 2017 Results presented at the 18th Annual Congress of the European League Against Rheumatism
    • 10 Jun 2017 Biomarkers information updated
    • 22 May 2017 According to a Fujifilm Kyowa Kirin Biologics media release, based on the top-line results of this trial announced on October 19, 2016, Fujifilm Kyowa Kirin Biologics decided to file the Marketing Authorisation Application (MAA) for FKB327, an adalimumab biosimilar, to the European Medicines Agency (EMA) in April 2017. On May 18, 2017, the EMA has accepted for review the MAA for FKB327.
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