Burmester, Gerd
Trefler, Jakub
Racewicz, Artur
Jaworski, Janusz
Zielińska, Agnieszka
Krogulec, Marek
Jeka, Sławomir
Wojciechowski, Rafał
Kolossa, Katarzyna
Dudek, Anna
Krajewska-Włodarczyk, Magdalena
Hrycaj, Paweł
Klimiuk, Piotr Adrian
Kim, SungHyun
Suh, JeeHye
Yang, GoEun
Kim, YunAh
Jung, YooBin
Park, GaHee
Smolen, Josef S. https://orcid.org/0000-0002-4302-8877
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47
https://doi.org/10.1136/rmdopen-2024-004514
Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis
https://doi.org/10.1007/s40261-025-01453-8
Funding for this research was provided by:
Celltrion
Open access funding provided by Medical University of Vienna
Medical University of Vienna
Article History
Accepted: 28 May 2025
First Online: 12 July 2025
Declarations
:
: Open access funding provided by Medical University of Vienna. This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The study sponsor, Celltrion, Inc. (Incheon, Republic of Korea), played a role in the study design, data collection and analysis, decision to publish and preparation of the manuscript.
: Gerd Burmester has received honoraria for consulting and lectures from Celltrion, Inc., Chugai, Fresenius and Sanofi. Marek Krogulec has received support for meeting attendance from Accord, Egis, Medac and Sandoz. Sławomir Jeka has received consulting fees from AbbVie, Celltrion, Inc., Eli Lilly, Gilead, MSD, Novartis, Pfizer, Roche, Sanofi and UCB; and payments or honoraria from AbbVie, Celltrion, Inc., Eli Lilly, Gilead, MSD, Novartis, Pfizer, Roche, Sanofi and UCB. Rafał Wojciechowski has received speaker fees from Eli Lilly, Janssen, Novartis, SOBI and UCB; support for meeting attendance from AbbVie; and is involved in the leadership of the Polish Rheumatology Society. Magdalena Krajewska-Włodarczyk has received payments or honoraria from AbbVie, Boehringer Ingelheim, Eli Lilly, Janssen, Medac, MSD, Novartis, Pfizer, Sandoz, SOBI and UCB; and support for meeting attendance from AbbVie, Medac, Novartis, Pfizer and SOBI. Paweł Hrycaj has received research grants from Celltrion, Inc. SungHyun Kim is an employee of Celltrion, Inc. JeeHye Suh, GoEun Yang, YunAh Kim, YooBin Jung and GaHee Park are employees of Celltrion, Inc., and hold stocks in Celltrion, Inc. Josef S. Smolen has received payments to his institution from AbbVie, AstraZeneca, Eli Lilly, Novartis, Galapagos and Roche; personal fees from AbbVie, Amgen, Ananda, Astro, BMS, Celltrion, Inc., Chugai, Eli Lilly, Gilead, Immunovant, MSD, Novartis, Pfizer, Roche, R-Pharma, Samsung, Sanofi and UCB; payments or honoraria from Eli Lilly; and support for meeting attendance from Eli Lilly. Jakub Trefler, Artur Racewicz, Janusz Jaworski, Agnieszka Zielińska, Katarzyna Kolossa, Anna Dudek and Piotr Adrian Klimiuk have no conflicts of interest that are directly relevant to the content of this article.
: The study was conducted in accordance with the Declaration of Helsinki (and Good Clinical Practice Guideline). All national, state, and local laws or regulations were followed. Prior to study initiation, the study protocol, informed consent form, advertisements used for the recruitment of participants and any other written materials provided to participants were approved by the institutional review board. This study involves human participants and was approved by the Institutional Review Board, Komisja Bioetyczna przy OIL w Białymstoku, ul. Świętojańska 7, 15-082 Białystok, Poland, and the Ethics Committee at the Regional Medical Chamber with its seat in Białystok, 15-082 Białystok, ul. Świętojańska 7, Poland (reference number: 43/2022/VIII).
: Written informed consent was obtained from all patients prior to enrolment.
: Not applicable.
: All data relevant to the study are included in the article or uploaded as supplementary information.
: Not applicable.
: GB, SHK, JHS, GEY, YAK, YBJ, GHP and JSS contributed to the study design. JT, AR, JJ, AZ, MK, SJ, RW, KK, AD, MKW, PH, PAK, SHK, GEY, YBJ and GHP contributed to the data collection. All authors contributed to the data analysis or interpretation, critically reviewed and critically revised the manuscript, approved the final version for publication, and agree to be accountable for the accuracy and integrity of the work.