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A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)

Crossref DOI link: https://doi.org/10.1186/s13075-024-03375-w

Published Online: 2024-09-07

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Leng, Xiaomei

Leszczyński, Piotr

Jeka, Slawomir

Liu, Shengyun

Liu, Huaxiang

Miakisz, Malgorzata

Gu, Jieruo

Kilasonia, Lali

Stanislavchuk, Mykola

Yang, Xiaolei

Zhou, Yinbo

Dong, Qingfeng

Mitroiu, Marian

Addison, Janet

Rezk, Mourad F.

Zeng, Xiaofeng
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Text and Data Mining valid from 2024-09-07

Version of Record valid from 2024-09-07
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Article History

Received: 20 February 2024

Accepted: 8 July 2024

First Online: 7 September 2024

Declarations

:

: The study was conducted in accordance with the Declaration of Helsinki and/or all relevant local regulations, in compliance with the International Council for Harmonisation Good Clinical Practice guidelines, and according to the appropriate regulatory requirements in the countries where the study was conducted.

: Not applicable.

: XL, SJ, SL, HL, MMia, JG, and XZ have no conflicts of interest. PL has received speaker fees from Novartis, AbbVie, UCB, MSD, and GSK; has received support for attending meetings from AbbVie, AstraZeneca, and Medac, and has received a grant for this study from Bio-Thera Solutions Ltd. LK has received speaker fees from Sandoz, Amgen, and Takeda. MS has received speaker fees from Pfizer, Orion, and Boehringer Ingelheim. XY, YZ, and QD are Bio-Thera Solutions Ltd employees and might hold stock, stock options, or both in Bio-Thera Solutions Ltd. MMit, JA, and MFR are Biogen employees and may hold stock, stock options, or both in Biogen.

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