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Hilt Christensen, C. C.
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Article History
Received: 14 January 2022
Accepted: 25 April 2022
First Online: 30 May 2022
Declarations
:
: OFSEP (Observatoire Français de la Sclérose en Plaques; French MS registry), ClinicalTrials.gov ID: NCT02889965, prospectively collects longitudinal data on clinical, biological, and imaging markers from patients who provided written informed consent following the French law on Bioethics. Storing data for research purposes was approved by the French Commission Nationale de l'Informatique et des Libertés (CNIL). MSBase is an international multiple sclerosis registry (World Health Organization International Clinical Trials Registry ID: ACTRN12605000455662) of observational data collected longitudinally as part of routine clinical care from 129 mostly tertiary multiple sclerosis centres in 36 countries. MSBase was approved by the Melbourne Health Human Research Ethics Committee and by the site institutional review boards, unless exemptions were granted according to the local regulations. Written informed consent was obtained from enrolled patients. The Danish Multiple Sclerosis Registry (DMSR) is a nationwide population-based registry consisting longitudinal data of all patients receiving disease-modifying treatments. Data are collected prospectively and stored following the data protection law of the Danish Data Inspection. The study obtained approvals from the Center for Data Review applications (j. nr. 2012–58-0004/VD-2018–121 I-suite 6361). Consent has been obtained from each patient included in this study. Please see ‘Ethics statement’ in the manuscript for details. All methods were carried out in accordance with relevant guidelines and regulations.
: Not applicable.
: OFSEP: The authors report the following relationships: speaker honoraria, advisory board or steering committee fees, independent data monitoring committees fee, consultancy and lecturing fees, principal investigator in clinical trials, research support, unconditional PhD donation and/or conference travel support from Actelion (PC, ET), Ad Scientiam (EM), Akcea (JPC), Alnylam (JPC), Almirall (OH), Bayer (GE, HZ, OH), Biogen (GE, JC, AR, JDS, EM, HZ, PL, GD, TM, EB, PC, JP, BS, ET, OH, BB, OC, AMo, JPC, AMa, IP, NM, DAL, SV, WA), Celgene (JC, ET, DAL), CSL-Behring (JPC), FHU Imminent (HZ), Geneuro (SV), Genzyme-Sanofi (GE, JC, AR, JDS, EM, HZ, PL, GD, CLF, TM, EB, PC, JP, BS, ET, OH, BB, OC, AMo, JPC, AMa, IP, NM, DAL, SV), Grifols (JPC), Laboratoire Français des Biotechnologies (JPC), LFB (GE), LFSEP (HZ), Merck / EMD (GE, JC, AR, EM, HZ, PL, GD, PC, JP, BS, ET, OH, BB, OC, AMo, JPC, AMa, NM, DAL, SV), Medday (EL, AR, TM, PC, JP, DAL, SV), Natus (JPC), Novartis (EL, GE, JC, AR, JDS, EM, HZ, PL, GD, CLF, TM, EB, PC, JP, BS, ET, OH, BB, OC, AMo, JPC, AMa, IP, NM, DAL, SV), Pfizer (JPC), Pharmalliance (JPC), Roche (ML, EL, GE, JC, AR, JDS, EM, HZ, PL, GD, CLF, EB, PC, JP, BS, ET, OH, BB, OC, AMa, NM, DAL, SV, WA), SNF-Floerger (JPC), Teva (GE, JC, AR, JDS, EM, HZ, PL, GD, EB, PC, JP, ET, OH, BB, AMo, JPC, AMa, SV), Académie de Médecine (HZ), Agence Nationale de la Recherche (DAL), French National Security Agency of Medicines and Health Products (EL), the EDMUS Foundation (EL), the ARSEP foundation (GE, HZ, ET, DAL,ML), PHRC Foundation (ET), Rennes University Hospital (GE). MSBase: The authors report the following relationships: speaker honoraria, advisory board or steering committee fees, research support and/or conference travel support from Actelion (EKH), Almirall (GI, FP, MT), Bayer (RA, FP, AL, MT, CB, MT, MS, JLS, BVW, TC, DS), BioCSL (KB, TK), Biogen (DH, EKH, RA, GI, FP, AL, PG, FGM, MG, PD, CB, MT, MS, JLS, PS, DF, FG, JP, BVW, TC, HB, TK), Canadian Multiple sclerosis society (PG, PD), Canadian Institutes of Health Research (MG, PD), Celgene (EKH, FP, TK), Czech Minsitry of Education (DH, EKH), Fondazione Italiana Sclerosi Multipla (FP, AL), Grifols (KB), Genzyme-Sanofi (DH, EKH, RA, GI, FP, AL, MT, PG, FGM, MG, PD, CB, MT, MS, JLS, PS, DF, FG, JP, BVW, TC, DS, HB, TK), GSK (RA), Merck / EMD (DH, EKH, RA, GI, FP, AL, MT, PG, MG, PD, CB, MT, MS, JLS, PS, DF, FG, KB, BVW, TC, DS, HB, TK), Mitsubishi (FGM), Ministero Italiano della Universit e della Ricerca Scientifica (FP), Mylan (FP, AL), Novartis (DH, EKH, RA, GI, FP, AL, MT, PG, FGM, MG, PD, CB, MT, MS, JLS, PS, DF, FG, JP, KB, BVW, TC, DS, HB, TK), ONO Pharmaceuticals (FGM), Roche (DH, EKH, RA, GI, FP, AL, MT, CB, FG, KB, BVW, TC, TK), Teva (DH, EKH, GI, FP, AL, MT, PG, FGM, MG, PD, CB, MT, JLS, PS, DF, JP, KB, BVW, TC, DS, TK), WebMD Global (TK). DMSR: The authors report the following relationships: speaker honoraria, advisory board or steering committee fees, independent data monitoring committees fee, consultancy fee, research support and/or conference travel support from Almirall (JF), Alexion (PVR), Bayer (HKM), Biogen (NKH, FS, CH, PVR, MBJ, JF, SB, HKM, KIS, MM), Bristol Myers Squibb (PVR), Celgene (PSS), Genzyme-Sanofi (FS, PSS, CH, PVR, MBJ, JF, SB, HKM, KIS, MM), GSK (PSS), Medday (PSS), Merck / EMD (JBA, NKH, FS, PSS, CH, PVR, MBJ, JF, SB, HKM, KIS, MM), Novartis (NKH, FS, PSS, CH, PVR, MBJ, JF, KIS, MM), Roche (FS, CH, PVR, MBJ, JF, SB, KIS, MM), Teva (NKH, FS, PSS, PVR, MBJ, JF, HKM, KIS, MM).