FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension

FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension

Abstract Objective To compare the efficacy, serum drug concentrations, immunogenicity, and safety of FKB327 with the adalimumab reference product (RP) in combination with methotrexate in patients with moderate-to-severe, active rheumatoid arthritis (RA). Methods Patients were randomized 1:1 in a dou...

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Bibliographic Details
Main Authors: Mark C. Genovese, Josephine Glover, Maria Greenwald, Wieslawa Porawska, Elias Chalouhi El Khouri, Eva Dokoupilova, Juan Ignacio Vargas, Mykola Stanislavchuk, Herbert Kellner, Elena Baranova, Nobuhito Matsunaga, Rieke Alten
Format: Article
Language:English
Published: BMC 2019-12-01
Series:Arthritis Research & Therapy
Subjects:
Rheumatoid arthritis
Adalimumab
Biosimilar
FKB327
Comparative clinical trials
Efficacy
Online Access:https://doi.org/10.1186/s13075-019-2046-0

Internet

https://doi.org/10.1186/s13075-019-2046-0

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