Maher, Toby M.
Bourdin, Arnaud
Volkmann, Elizabeth R.
Vettori, Serena
Distler, Jörg H. W.
Alves, Margarida
Stock, Christian
Distler, Oliver
Funding for this research was provided by:
The SENSCIS trial was supported by Boehringer Ingelheim International GmbH.
Article History
Received: 2 March 2022
Accepted: 19 June 2022
First Online: 5 July 2022
Declarations
:
: The SENSCIS trial was carried out in compliance with the principles of the Declaration of Helsinki and the Harmonized Tripartite Guideline for Good Clinical Practice of the International Conference on Harmonization, and was approved by the local authorities. The clinical protocol was approved by an independent ethics committee or institutional review board at each participating center (listed in the supplement to the primary manuscript on the trial results [CitationRef removed]). Subjects provided written informed consent before trial entry.
: Not applicable.
: TMM reports consulting fees from AstraZeneca, Bayer, Blade Therapeutics, BI, Bristol Myers Squibb, Galapagos, Galecto, GlaxoSmithKline, IQVIA, Pliant, Respivant Sciences, Roche/Genentech, Theravance Biopharma, Veracyte and payment for presentations from BI and Roche/Genentech. AB reports grants from AstraZeneca and BI; consulting fees from Amgen, AstraZeneca, BI, Chiesi, GlaxoSmithKline, Novartis, Regeneron, Sanofi; payment for presentations, speakers bureaus, or educational events, and support for attending meetings from AstraZeneca, BI, Chiesi, GlaxoSmithKline, Novartis, Regeneron; and participation on a Data Safety Monitoring Board or advisory board for AB Science. ERV reports grants from BI, Forbius, Kadmon, Horizon and fees from BI for serving on advisory boards and for presentations. SV reports consulting fees from BI. JHWD reports grants, consulting fees and payment for presentations, speakers bureaus, or educational events from BI and stock in 4D Science. MA and CS are employees of Boehringer Ingelheim. OD has received grants BI, Kymera, Mitsubishi Tanabe; consultancy fees from AbbVie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, AstraZeneca, Bayer, Beacon, Blade Therapeutics, BI, Corbus, CSL Behring, 4P Science, Galapagos, Glenmark Pharmaceuticals, Horizon Therapeutics (Curzion), Inventiva, Kymera, Lupin, Merck Sharp & Dohme, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Pfizer, Prometheus Biosciences, Roivant Sciences, Sanofi, Topadur; speaking fees from Bayer, BI, Janssen, Medscape; he holds patent US8247389 for the treatment of SSc; he is Chair of the Executive Committee of the FOREUM Foundation, co-chair of a ERS/EULAR guidelines committee, President of EUSTAR, a Member of the Board of Trustees for the Swiss Clinical Quality Management in Rheumatic Diseases and the Hartmann Müller Foundation, and a Senate member of the Swiss Academy of Medical Sciences.