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Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study.

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Title: Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study.
Authors: Giovannoni G; Department of Neurology, Royal London Hospital, Barts Health NHS Trust, London, UK; Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK. Electronic address: g.giovannoni@qmul.ac.uk., Airas L; Clinical Neurosciences and InFLAMES Research Flagship, University of Turku, Turku, Finland; Neurocenter, Turku University Hospital, Turku, Finland., Bove R; UCSF Weill Institute for Neuroscience, Department of Neurology, University of California San Francisco, San Francisco, CA, USA., Cutter GR; University of Alabama at Birmingham, Birmingham, AL, USA., Czarnecki M; Centrum Medyczne NeuroProtect, Warsaw, Poland., Drulovic J; University Clinical Center of Serbia and University of Belgrade, Faculty of Medicine, Belgrade, Serbia., Hobart J; Peninsula Medical School, Plymouth University, Plymouth, UK., Kuhle J; MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel, University of Basel, Basel, Switzerland., Montalban X; Centre d'Esclerosi Múltiple de Catalunya, Vall d'Hebron University Hospital, Barcelona, Spain., Selmaj KW; University of Warmia and Mazury, Olsztyn, Lodz, Poland; Center for Neurology, Lodz, Poland., Tur C; Queen Square MS Centre, Department of Neuroinflammation, Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK; Neurology-Neuroimmunology Department, Multiple Sclerosis Centre of Catalonia, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain., Wolinsky JS; Department of Neurology, University of Texas Health Science Center, Houston, TX, USA., Baldinotti A; F Hoffmann-La Roche, Basel, Switzerland., Bonati U; F Hoffmann-La Roche, Basel, Switzerland., Craveiro L; F Hoffmann-La Roche, Basel, Switzerland., Giacobino C; F Hoffmann-La Roche, Basel, Switzerland., Manfrini M; F Hoffmann-La Roche, Basel, Switzerland., Schneble HM; F Hoffmann-La Roche, Basel, Switzerland., Stevenson P; F Hoffmann-La Roche, Basel, Switzerland., Wang Q; F Hoffmann-La Roche, Basel, Switzerland., Yang K; F Hoffmann-La Roche, Basel, Switzerland., Oh J; Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Corporate Authors: ORATORIO-HAND study group
Source: Lancet (London, England) [Lancet] 2026 May 30; Vol. 407 (10544), pp. 2195-2207.
Publication Type: Journal Article; Multicenter Study; Clinical Trial, Phase III; Randomized Controlled Trial
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study.
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  Data: <searchLink fieldCode="AU" term="%22Giovannoni+G%22">Giovannoni G</searchLink>; Department of Neurology, Royal London Hospital, Barts Health NHS Trust, London, UK; Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK. Electronic address: g.giovannoni@qmul.ac.uk.<br /><searchLink fieldCode="AU" term="%22Airas+L%22">Airas L</searchLink>; Clinical Neurosciences and InFLAMES Research Flagship, University of Turku, Turku, Finland; Neurocenter, Turku University Hospital, Turku, Finland.<br /><searchLink fieldCode="AU" term="%22Bove+R%22">Bove R</searchLink>; UCSF Weill Institute for Neuroscience, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Cutter+GR%22">Cutter GR</searchLink>; University of Alabama at Birmingham, Birmingham, AL, USA.<br /><searchLink fieldCode="AU" term="%22Czarnecki+M%22">Czarnecki M</searchLink>; Centrum Medyczne NeuroProtect, Warsaw, Poland.<br /><searchLink fieldCode="AU" term="%22Drulovic+J%22">Drulovic J</searchLink>; University Clinical Center of Serbia and University of Belgrade, Faculty of Medicine, Belgrade, Serbia.<br /><searchLink fieldCode="AU" term="%22Hobart+J%22">Hobart J</searchLink>; Peninsula Medical School, Plymouth University, Plymouth, UK.<br /><searchLink fieldCode="AU" term="%22Kuhle+J%22">Kuhle J</searchLink>; MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel, University of Basel, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Montalban+X%22">Montalban X</searchLink>; Centre d'Esclerosi Múltiple de Catalunya, Vall d'Hebron University Hospital, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Selmaj+KW%22">Selmaj KW</searchLink>; University of Warmia and Mazury, Olsztyn, Lodz, Poland; Center for Neurology, Lodz, Poland.<br /><searchLink fieldCode="AU" term="%22Tur+C%22">Tur C</searchLink>; Queen Square MS Centre, Department of Neuroinflammation, Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK; Neurology-Neuroimmunology Department, Multiple Sclerosis Centre of Catalonia, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Wolinsky+JS%22">Wolinsky JS</searchLink>; Department of Neurology, University of Texas Health Science Center, Houston, TX, USA.<br /><searchLink fieldCode="AU" term="%22Baldinotti+A%22">Baldinotti A</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Bonati+U%22">Bonati U</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Craveiro+L%22">Craveiro L</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Giacobino+C%22">Giacobino C</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Manfrini+M%22">Manfrini M</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Schneble+HM%22">Schneble HM</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Stevenson+P%22">Stevenson P</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Wang+Q%22">Wang Q</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Yang+K%22">Yang K</searchLink>; F Hoffmann-La Roche, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Oh+J%22">Oh J</searchLink>; Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
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              Text: 2026 May 30
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