Ziemssen, Tjalf http://orcid.org/0000-0001-8799-8202
Bass, Ann D.
Berkovich, Regina
Comi, Giancarlo
Eichau, Sara
Hobart, Jeremy
Hunter, Samuel F
LaGanke, Christopher
Limmroth, Volker
Pelletier, Daniel
Pozzilli, Carlo
Schippling, Sven
Sousa, Livia
Traboulsee, Anthony
Uitdehaag, Bernard M. J.
Van Wijmeersch, Bart
Choudhry, Zia
Daizadeh, Nadia
Singer, Barry A.
,
Funding for this research was provided by:
Sanofi
Bayer Healthcare Pharmaceuticals
Article History
First Online: 24 July 2020
Compliance with Ethical Standards
:
: TZ, ADB, RB, GC, SE, JH, SFH, CL, VL, DP, CP, SS, LS, AT, BMJU, BVW, and BAS contributed to study design, data collection, drafting and critical review of the manuscript, and approval of the final submission. ZC contributed to drafting and critical review of the manuscript, and approval of the final submission. ND led the statistical support, contributed to the drafting and critical review of the manuscript, and approved the final submission.
: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: ExternalRef removed.
: The CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ studies were funded by Sanofi and Bayer HealthCare Pharmaceuticals. Medical writing support was funded by Sanofi.
: TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, and Teva) and grant/research support (Biogen, Novartis, Sanofi, and Teva). ADB: Consulting fees/fees for non-CME services from commercial interests or their agents/grant and research support (Biogen, EMD Serono, Mallinckrodt, Novartis, Roche-Genentech, Sanofi, and TG Therapeutics). RB: Advisory boards and consulting (Acorda, Avanir, Bayer, Biogen, Novartis, Questcor, Sanofi, and Teva). GC: Consulting fees (Actelion, Bayer Schering, Merck Serono, Novartis, Sanofi, and Teva); lecture fees (Bayer Schering, Biogen Dompé, Merck Serono, Novartis, Sanofi, Serono, Symposia International Foundation, and Teva). SE: Speaking and/or consulting (Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). JH: Consulting fees, honoraria, travel payment, or research support (Acorda, Bayer-Schering, Biogen, Global Blood Therapeutics, LORA Group, Merck Serono, Novartis, Oxford PharmaGenesis, Roche, Sanofi, Teva, and Vantia) and license fee/royalty payments (Plymouth University). SFH: Consulting agreements, speaker honoraria, writing support, and grant/research financial support (AbbVie, Actelion-Janssen, Adamas, Alkermes, Biogen, Genentech-Roche, Genzyme, Novartis, Osmotica, Mallinckrodt, and Sanofi-Genzyme). CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi, Strativa, Teva, and UCB). VL: Honoraria for consulting and speaking at symposia (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva, with approval by the HR Department, Cologne General Hospital, and University of Cologne). DP: Consulting and/or speaking fees and grant/research support (Biogen, Merck Serono, Novartis, Roche, and Sanofi). CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). SS: Consulting and/or speaking fees (Biogen, Merck Serono, Novartis, Sanofi, and Teva) and grant/research support (Novartis and Sanofi). LS: Compensation for advisory board and speaking fees (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, Sanofi, and Teva). BMJU: Consulting fees (Biogen, Genzyme, Merck Serono, Novartis, Roche, and Teva). BVW: Research and travel grants, honoraria for MS-expert advice, and speaking fees (Actelion, Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). ZC and ND: Employees of Sanofi. BAS: Speaking and/or consulting (AbbVie, Bayer, Biogen, Celgene, EMD Serono, Genentech, Novartis, Roche, Sanofi, Teva, and TG Therapeutics), and research support (AbbVie, Alkermes, Biogen, MedImmune, Novartis, Roche, and Sanofi).
: Patients provided written informed consent, and all procedures were approved by local institutional ethics review boards of participating sites.