Document is current
Any future updates will be listed below
-
Authors
Pongratz, Georg https://orcid.org/0000-0002-2185-8458
Alten, Rieke https://orcid.org/0000-0002-3395-4412
Witte, Torsten https://orcid.org/0000-0003-4531-0267
Pausch, Christine https://orcid.org/0000-0002-1866-9015
Reinhold, Robert https://orcid.org/0009-0006-4202-3800
Pittrow, David https://orcid.org/0000-0003-1136-2616
Burmester, Gerd R. https://orcid.org/0000-0001-7518-1131
-
Funding
Funding for this research was provided by:
Alfasigma GmbH
- License Information
-
More Information
Article History
Received: 9 October 2025
Accepted: 21 November 2025
First Online: 12 January 2026
Declarations
:
: Georg Pongratz has received consultancy fees and speaker fees from AbbVie, Alfasigma, Boehringer Ingelheim, Eli Lilly & Co., Galapagos, Pfizer, Roche, Sanofi, Viatris and Vertanical. Rieke Alten has received consultancy fees and speaker fees from AbbVie, Alfasigma, Amgen, Biogen, BMS, Celltrion, Chugai, Eli Lilly & Co., Galapagos, Gilead, Hexal, Janssen, Novartis, Pfizer, Roche, UCB and Viatris. Torsten Witte has received consultancy fees and speaker fees from AbbVie, Alfasigma, Eli Lilly & Co. and Pfizer. Christine Pausch has no conflicts of interest. Robert Reinhold is an employee of Alfasigma GmbH. David Pittrow has received consultancy fees from Alfasigma, Amgen, Aspen, Bayer, Biogen, Boehringer Ingelheim, Daiichi Sankyo, MSD, Sandoz/Hexal, Sanofi-Genzyme, Takeda, Viatris and Zambon. Gerd R. Burmester has received consultancy fees and speaker fees from AbbVie, Alfasigma, BMS, Eli Lilly & Co., Galapagos, Janssen, Novartis, Pfizer, Sanofi and UCB.
: The Ethics Committee of the Saxony State Chamber of Physicians in Dresden approved the study (EK-BR-2/25-1) on 28 March 2025. The ethics committees of the State Chambers of Physicians in North Rhine (2025115, 18 July 2025) and Baden-Württemberg (B-F-2025-058, 30 October 2025) subsequently acknowledged this approval. Additional local ethics committees accepted the lead vote according to the “one study – one vote” procedure. The FIRST-RA study is conducted in accordance with the Declaration of Helsinki, Good Pharmacoepidemiology Practices (GPP), Good Pharmacovigilance Practices (GVP) and applicable regulatory requirements in Germany and Austria. The study is registered in the German Clinical Trials Register under DRKS00036136. It is also registered with the Federal Institute for Drugs and Medical Devices (BfArM) under NIS 7864. All participants provide written informed consent before any study-related documentation is performed.
