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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

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

Most Recent Events

18 Feb 2021 Results published in the Viatris Inc Media Release
09 Jul 2020 According to a Mylan media release, based on this study, the U.S. Food and Drug Administration (FDA) has approved Hulio (adalimumab-fkjp), in both prefilled syringe and auto-injector presentations.
15 Jun 2019 Results presented at the 20th Annual Congress of the European League Against Rheumatism

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