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P422 : Immunogenicity of a proposed adalimumab biosimilar, FKB327, and the reference product in patients with rheumatoid arthritis

Researchers

Presenter

  • R Alten

Principal Investigators

  • C Markland

  • K Kawakami

  • M Boyce

  • F Casty

  • R Muniz

  • M C Genovese

Medical Centers

  • Schlosspark Klinik, University Medicine Berlin, Head of Department of Internal Medicine II, Rheumatology, Clinical Immunology, Osteology Director of Rheumatology Research Center, Berlin, Germany

  • NDA Group, Leatherhead, Surrey, UK

  • Fujifilm Kyowa Kirin Biologics Co., Ltd., Clinical Development Department, Tokyo, Japan

  • Hammersmith Medicines Research, London, United Kingdom

  • Mylan Inc., Global Medical Affairs, Canonsburg, USA

  • Stanford University School of Medicine, James W. Raitt Endowed Professor of Medicine Co-Chief Division of Immunology and Rheumatology, Palo Alto, USA

Locations

  • Germany

  • United Kingdom

  • Japan

  • United States

Companies

  • N/A

Study Components

Therapeutic Area

  • Autoimmune (AI)

Disease

  • Rheumatoid arthritis

Biomarkers

  • N/A

Drug/Treatment

  • Adalimumab biosimilar

  • FKB327

Outcome

  • N/A


Study Design

  • Randomized

Phase

  • III

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A