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1.
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10 p, 1.1 MB |
The Multiple Sclerosis Care Unit
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Sørensen, Per S (Copenhagen University Hospital) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Thalheim, Christoph (European Multiple Sclerosis Platform, Brussels) ;
Zaratin, Paola (Multiple Sclerosis International Federation (MSIF)) ;
Comi, Giancarlo (San Raffaele Hospital, Milan) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Treatment of multiple sclerosis (MS) has become increasingly multifaceted and comprises not only a variety of disease-modifying drugs with different mechanism of action but also a wide range of symptomatic therapies. [...]
2019 -  10.1177/1352458518807082
Multiple sclerosis, Vol. 25 Núm. 5 (april 2019) , p. 627-636
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2.
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9 p, 570.9 KB |
Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis : An Integrated Analysis of Safety
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Giovannoni, Gavin (Queen Mary University of London) ;
Galazka, Andrew (Merck. Aubonne. Switzerland. a division of Merck KGaA) ;
Schick, Regina (Merck KGaA) ;
Leist, Thomas (Jefferson University) ;
Comi, Giancarlo (Università Vita-Salute San Raffaele. Ospedale San Raffaele) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Damian, Doris (EMD Serono Research and Development Institute. Inc) ;
Dangond, Fernando (EMD Serono Research and Development Institute. Inc) ;
Cook, Stuart (The State University of New Jersey) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Introduction: Although use of contraception was pre-specified during cladribine clinical trials for multiple sclerosis, some pregnancies did occur. Objective: This analysis reports on pregnancy outcomes in the cladribine clinical development program. [...]
2020 - 10.1007/s40264-020-00948-x
Drug Safety, Vol. 43 Núm. 7 (july 2020) , p. 635-643
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3.
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14 p, 1.0 MB |
Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis : 6-year results from the SELECTED open-label extension study
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Gold, Ralf (Ruhr-University Bochum) ;
Radue, Ernst-Wilhem (University Hospital Basel (Basilea, Suïssa)) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Selmaj, Krzysztof. (University of Warmia and Mazury) ;
Havrdova, Eva Kubala (Charles University) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Stefoski, Dusan (Rush University Medical Center) ;
Sprenger, Till (DKD Helios Klinik Wiesbaden) ;
Robinson, Randy R. (AbbVie Inc.) ;
Fam, Sami (Biogen) ;
Smith, Jonathan (Biogen) ;
Chalkias, Spyros (Biogen) ;
Giannattasio, Giorgio (Biogen) ;
Lima, Gabriel (Biogen) ;
Castro-Borrero, Wanda (Biogen) ;
Universitat Autònoma de Barcelona
Objective: SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. [...]
2020 - 10.1007/s00415-020-09835-y
Journal of Neurology, Vol. 267 Núm. 10 (january 2020) , p. 2851-2864
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4.
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11 p, 1.1 MB |
Safety of cladribine tablets in the treatment of patients with multiple sclerosis : An integrated analysis
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Cook, Stuart (Rutgers. The State University of New Jersey) ;
Leist, Thomas (Jefferson University) ;
Comi, Giancarlo (Università Vita-Salute San Raffaele) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Nolting, Axel (Merck KGaA) ;
Hicking, Christine (Merck KGaA) ;
Galazka, Andrew (Merck. Zone Industrielle de L'Ouriettaz) ;
Sylvester, Elke (Merck KGaA) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Background: Treating patients with relapsing multiple sclerosis (MS) with cladribine tablets (two times 4 or 5 days of treatment each year for 2 years) results in long-lasting efficacy, with continued stability in many patients for 4 or more years. [...]
2019 - 10.1016/j.msard.2018.11.021
Multiple Sclerosis and Related Disorders, Vol. 29 (april 2019) , p. 157-167
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5.
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17 p, 300.8 KB |
Expert opinion on the use of cladribine tablets in clinical practice
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Sørensen, Per Soelberg (University of Copenhagen) ;
Centonze, Diego (Unit of Neurology and Neurorehabilitation) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Selchen, Daniel (St. Michael's Hospital, Toronto) ;
Vermersch, Patrick (Univ. Lille) ;
Wiendl, Heinz (University of Münster) ;
Yamout, Bassem (American University of Beirut) ;
Salloukh, Hashem (Ares Trading S.A. Merck Serono S.A) ;
Rieckmann, Peter (University of Erlangen) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Background: Gaps in current product labels and a lack of detailed clinical guidelines leaves clinicians' questions on the practical management of patients receiving cladribine tablets for the treatment of relapsing multiple sclerosis (MS) unanswered. [...]
2020 - 10.1177/1756286420935019
Therapeutic Advances in Neurological Disorders, Vol. 13 (2020)
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6.
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8 p, 915.8 KB |
Long-term safety data from the cladribine tablets clinical development program in multiple sclerosis
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Leist, Thomas (Jefferson University) ;
Cook, S. (New Jersey Medical School) ;
Comi, Giancarlo (Università Vita-Salute San Raffaele) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Nolting, A. (Merck KGaA) ;
Damian, D. (Merck KGaA) ;
Syed, S. (Merck KGaA) ;
Galazka, Andrew (Merck KGaA) ;
Universitat Autònoma de Barcelona
Background: Long-term safety data are of particular interest for any newly approved treatment in multiple sclerosis such as cladribine tablets 10 mg (MAVENCLAD®; 3. 5 mg/kg cumulative dose over 2 years, referred to as cladribine tablets 3. [...]
2020 - 10.1016/j.msard.2020.102572
Multiple Sclerosis and Related Disorders, Vol. 46 (november 2020) , p. 102572
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7.
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12 p, 1.3 MB |
Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS : an ambispective study
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Giovannoni, Gavin (Queen Mary and Westfield College (University of London)) ;
Boyko, Alexey (Pirogov Russian National Research Medical University.) ;
Correale, Jorge (Departamento de Neurologia, FLENI Instituto.) ;
Edan, Gilles (Department of Neurology, University Hospital of Rennes.) ;
Freedman, Mark S. (Department of Medicine and the Ottawa Hospital Research Institute.) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Rammohan, Kottil (MS Research Center, School of Medicine, University of Miami) ;
Stefoski, Dusan (Department of Neurological Sciences, Rush Medical College) ;
Yamout, Bassem (UAE/American University of Beirut Medical Center) ;
Leist, Thomas (Division of Clinical Neuroimmunology, Comprehensive MS Center, Jefferson University) ;
Aydemir, Aida (EMD Serono Research & Development Institute, Inc.) ;
Borsi, Laszlo (Merck Healthcare KGaA.) ;
Verdun, di Cantogno E (EMD Serono Research & Development Institute, Inc.) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Background: CLASSIC-MS evaluated the long-term efficacy of cladribine tablets in patients with relapsing multiple sclerosis. Objective: Report long-term mobility and disability beyond treatment courses received in CLARITY/CLARITY Extension. [...]
2023 - 10.1177/13524585231161494
Multiple sclerosis, Vol. 29 Núm. 6 (2023) , p. 719-730
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8.
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9 p, 341.7 KB |
Risk of requiring a wheelchair in primary progressive multiple sclerosis : Data from the ORATORIO trial and the MSBase registry
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Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Butzkueven, Helmut (Monash University) ;
Spelman, Tim (University of Melbourne) ;
Horakova, Dana (Charles University. Faculty of Medicine in Hradec Králové) ;
Hughes, Stella (Craigavon Area Hospital) ;
Solaro, Claudio Marcello (CRRF "Mons. Luigi Novarese") ;
Izquierdo, Guillermo (Hospital Vithas Nisa) ;
Kubala Havrdova, Eva (Charles University) ;
Grand'Maison, Francois (Neuro Rive-Sud) ;
Prat, Alexandre (Universite de Montreal) ;
Girard, Marc (Universite de Montreal) ;
Hupperts, Raymond (Zuyderland Ziekenhuis) ;
Onofrj, Marco (University G. d'Annunzio) ;
Lugaresi, Alessandra (UOSI Riabilitazione Sclerosi Multipla) ;
Taylor, Bruce (Royal Hobart Hospital) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Kappos, Ludwig (University of Basel) ;
Hauser, Stephen L. (University of California) ;
Craveiro, Licinio (F. Hoffmann-La Roche Ltd) ;
Freitas, Rita (F. Hoffmann-La Roche Ltd) ;
Model, Fabian (F. Hoffmann-La Roche Ltd) ;
Overell, James (F. Hoffmann-La Roche Ltd) ;
Muros-Le Rouzic, Erwan (F. Hoffmann-La Roche Ltd) ;
Sauter, Annette (F. Hoffmann-La Roche Ltd) ;
Wang, Qing (F. Hoffmann-La Roche Ltd) ;
Wormser, David (F. Hoffmann-La Roche Ltd) ;
Wolinsky, Jerry S. (McGovern Medical School) ;
MSBase Study Group ;
Universitat Autònoma de Barcelona
Background and purpose: Reaching Expanded Disability Status Scale (EDSS) ≥7. 0 represents the requirement for a wheelchair. Here we (i) assess the effect of ocrelizumab on time to EDSS ≥7. 0 over the ORATORIO (NCT01194570) double-blind and extended controlled periods (DBP+ECP), (ii) quantify likely long-term benefits by extrapolating results, and (iii) assess the plausibility of extrapolations using an independent real-world cohort (MSBase registry; ACTRN12605000455662). [...]
2022 - 10.1111/ene.14824
European Journal of Neurology, Vol. 29 Núm. 4 (2022) , p. 1082-1090
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9.
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8 p, 1.1 MB |
Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis : Benefit/risk following review of trial and post-marketing data
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Coles, Alasdair J. (University of Cambridge) ;
Jones, Joanne L. (University of Cambridge) ;
Vermersch, Patrick (Université de Lille) ;
Traboulsee, Anthony (University of British Columbia) ;
Bass, Ann D. (Neurology Center of San Antonio) ;
Boster, Aaron (Boster Center for Multiple Sclerosis) ;
Chan, Andrew (University of Bern) ;
Comi, Giancarlo (Vita-Salute San Raffaele University) ;
Fernández, Óscar (Hospital Regional Universitario Carlos Haya (Málaga)) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Kubala Havrdova, Eva (Charles University) ;
LaGanke, Christopher (North Central Neurology Associates) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Oreja-Guevara, Celia (Universidad Complutense de Madrid) ;
Piehl, Fredrik (Karolinska Institutet (Estocolm, Suècia)) ;
Wiendl, Heinz (University of Münster) ;
Ziemssen, Tjalf (Dresden University of Technology) ;
Universitat Autònoma de Barcelona
Does preexisting or treatment-emergent autoimmunity increase the risk of subsequent autoimmune disease in individuals with relapsing-remitting multiple sclerosis (MS) after alemtuzumab? In the extended phase 2/3 trials, 34/96 (35. [...]
2022 - 10.1177/13524585211061335
Multiple sclerosis, Vol. 28 Núm. 5 (2022) , p. 842-846
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