Simbrich, Alexandra http://orcid.org/0000-0001-8689-6634
,
Thibaut, Jasmine
Khil, Laura
Maximov, Stanislav
Wiendl, Heinz
Berger, Klaus
Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01GI1602E, 01GI0907)
Westfälische Wilhelms-Universität Münster
Article History
Accepted: 27 September 2020
First Online: 23 October 2020
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. REGIMS is funded by the German Ministry of Research and Education (BMBF) within the German Competence Net Multiple Sclerosis (FKZ: 01GI1602E, 01GI0907). Co-funding is provided by Biogen (for the documentation of patients receiving natalizumab [Tysabri<sup>®</sup>]).
: AS and JT report a grant from the BMBF (within the German Competence Net Multiple Sclerosis) plus additional funds from Biogen, all to the University of Münster, during the implementation of the REGIMS registry. KB received a grant from the BMBF (within the German Competence Net Multiple Sclerosis) plus additional funds from Biogen, all to the University of Münster, for an investigator-initiated AE registry for patients with multiple sclerosis. HW received grants from the BMBF, Deutsche Forschungsgemeinschaft (DFG), Else Kröner Fresenius Foundation, Fresenius Foundation, the European Union, Hertie Foundation, NRW Ministry of Education and Research, Interdisciplinary Center for Clinical Studies (IZKF) Muenster and RE Children’s Foundation, Biogen, GlaxoSmithKline GmbH, Roche Pharma AG, and Sanofi-Genzyme; consulting fees from AbbVie, Actelion, Biogen, IGES, Johnson & Johnson, Novartis, Roche, and Sanofi-Aventis; support for travel to meetings for other purposes from AbbVie, Actelion, Biogen, IGES, Johnson & Johnson, Novartis, Roche, and Sanofi-Aventis; fees for participation in review activities such as data monitoring boards from PSI CRO Deutschland GmbH, and the Swiss Multiple Sclerosis Society; payment for lectures from Alexion, Biogen, Cognomed, F. Hoffmann-La Roche Ltd., Gemeinnützige Hertie-Stiftung, Merck Serono, Novartis, Roche Pharma AG, Genzyme, TEVA, and WebMD Global; and honorarium for expert testimony from Alexion, Biogen, Merck Serono, Novartis, and Genzyme outside the submitted work. He has filed patents no. SEP-103.323–1/08, EP2769223, WO2013057092 (A1), and 15001186.4–1402. LK and SM have nothing to disclose.
: Ethical approval was obtained for the study.
: All patients enrolled in the REGIMS registry provided written informed consent at enrollment. The registry is conducted in accordance with the principles of the Declaration of Helsinki and is consistent with the International Council for Harmonization/Good Clinical Practice.
: Not applicable.
: The datasets generated during and/or analyzed within the REGIMS registry are not publicly available because of the nature of the sensitive electronic medical data. Data from the KKNMS projects are available for scientific projects for network members as well as for other research institutions. The FaBIO committee of the KKNMS decides on the applications in a two-stage process. More information is provided on the website of the KKNMS: ExternalRef removed
: The code for the statistical analyses is available on request.
: The project has been registered at the German Clinical Study Register (DRKS, Deutsches Register Klinischer Studien, no. DRKS00007190 and no. DRKS 00007127 [Tysabri® part]).
: AS: Drafted the manuscript for intellectual content; analyzed the data; interpreted the data; revised the manuscript for intellectual content. JT: Designed and conceptualized the manuscript; drafted the manuscript for intellectual content; interpreted the data; revised the manuscript for intellectual content. LK: Revised the manuscript for intellectual content; interpreted the data. SM: Coordinated the dataflow and managed the registry data; made substantial contributions to the acquisition of data; revised the manuscript for intellectual content. HW: Interpreted the data; revised the manuscript for intellectual content. KB: Interpreted the data; revised the manuscript for intellectual content. All authors read and approved the final version.