Schiffmann, Insa https://orcid.org/0000-0001-8315-5398
Freund, Magalie
Vettorazzi, Eik
Stellmann, Jan-Patrick
Heyer-Borchelt, Susanne
D’Hooghe, Marie
Häußler, Vivien
Rahn, Anne Christin
Heesen, Christoph
Funding for this research was provided by:
Sanofi Genzyme (-)
Article History
Received: 26 January 2020
Accepted: 1 November 2020
First Online: 9 December 2020
Ethics approval and consent to participate
: Ethical approval has been obtained from the ethical committee of Hamburg Chamber of Physicians (approval number: PV5722) as well as local committees at each centre location. Protocol amendments, if necessary, will be reported to the sponsor, communicated to participating centres and sent to the leading ethics committee at the Hamburg Chamber of Physicians. Upon acceptance, clinical trial registry will be adapted. Deviations from the protocol will be documented using a breach report form. Written informed consent will be obtained from all study participants. On the consent form, participants will be asked if they agree to use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the universities taking part in the research or from regulatory authorities, where relevant. This trial does not involve collecting biological specimens for storage.
: Results of the trial will be submitted for publication in a scientific journal, reported to the sponsor as well as the trial registry and distributed among pwMS via the newsletter of the MS dayclinic of the University Medical Centre Hamburg-Eppendorf.
: Insa Schiffmann has received travel grants from Sanofi-Genzyme.Magalie Freund has nothing to declare.Eik Vettorazzi has nothing to declare.Anne Rahn was supported by a research grant from the National MS Society, USA (grant no. G-1508-06034).Jan-Patrick Stellmann received research funding from Deutsche Forschungsgemeinschaft and reports grants from Biogen and Genzyme.Susanne Heyer-Borchelt has nothing to declare.Marie D’Hooge has nothing to declare for this study.Vivien Häußler has nothing to declare.Christoph Heesen received speaker honoraria and grants from Biogen, Genzyme, Merck, Novartis and Roche.