RECLAIM – A retrospective, multicentre observational study aimed at enabling the development of artificial intelligence-driven prognostic models for disease progression in multiple sclerosis

Jelle Praet^1*Lina Anderhalten^2,3Giancarlo Comi^4,5Dana Horakova⁶Tjalf Ziemssen⁷Patrick Vermersch⁸Carsten Lukas⁹Koen Van Leemput^10,11,12Marjan Steppe¹³Noemí Manero¹⁴Ella Maria Kadas¹⁵Alexis Bernard¹⁶Jean Van Rampelbergh¹⁷Erik De Boer¹⁸Vera Zingler¹⁹Dirk Smeets¹Annemie Ribbens¹Friedemann Paul^2,20,21,3

• ¹Icometrix (Belgium), Leuven, Belgium
• ²Experimental and Clinical Research Center, Charite University Medicine Berlin, Berlin, Baden-Wurttemberg, Germany
• ³Max Delbrück Center for Molecular Medicine, Helmholtz Association of German Research Centers (HZ), Berlin, Baden-Wurttemberg, Germany
• ⁴Casa di Cura Igea, Milan, Lombardy, Italy
• ⁵Vita-Salute San Raffaele University, Milan, Lombardy, Italy
• ⁶Department of Neurology, First Faculty of Medicine, Charles University, Prague, Prague, Czechia
• ⁷Center for Clinical Neuroscience, University Hospital Carl Gustav Carus, Dresden, Lower Saxony, Germany
• ⁸University Lille, Inserm U1172 LilNCog, Centre Hospitalier Universitaire de Lille, Lille, Nord-Pas-de-Calais, France
• ⁹Institute of Neuroradiology, St. Josef Hospital, Ruhr-University Bochum, Bochum, North Rhine-Westphalia, Germany
• ¹⁰Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States
• ¹¹Department of Neuroscience and Biomedical Engineering, School of Science, Aalto University, Espoo, Ostrobothnia, Finland
• ¹²Department of Computer Science, School of Science, Aalto University, Otakaari, Ostrobothnia, Finland
• ¹³European Charcot Foundation, Brussels, Belgium
• ¹⁴SYNAPSE research management partners, Madrid, Asturias, Spain
• ¹⁵Nocturne (Germany), Berlin, Baden-Württemberg, Germany
• ¹⁶AB Science, Paris, France
• ¹⁷Imcyse, Liege, Belgium
• ¹⁸Bristol-Myers Squibb company corp, Princeton, New Jersey, United States
• ¹⁹F. Hoffmann-La Roche Ltd., Product Development Medical Affairs, Neuroscience, Basel, Switzerland
• ²⁰Neuroscience Clinical Research Center (NCRC), Charité University Medicine Berlin, Berlin, Baden-Württemberg, Germany
• ²¹Department of Experimental Neurology, Clinic for Neurology with Experimental Neurology, Charité University Medicine Berlin, Berlin, Baden-Wurttemberg, Germany

Multiple sclerosis (MS) is characterised by a progressive worsening of disability over time. As many regulatory-cleared disease-modifying treatments aiming to slow down this progression are now available, a clear need has arisen for a personalised and data-driven approach to treatment optimisation in order to more efficiently slow down disease progression and eventually, progressive disability worsening. This strongly depends on the availability of biomarkers that can detect and differentiate between the different forms of disease worsening, and on predictive models to estimate the disease trajectory for each patient under certain treatment conditions. To this end, we here describe a multicentre, retrospective, observational study, aimed at setting up a harmonised database to allow the development, training, optimisation, and validation of such novel biomarkers and AI-based decision models. Additionally, the data will be used to develop the tools required to better monitor this progression and to generate further insights on disease worsening and progression, patient prognosis, treatment decisions and responses, and patient profiles of patients with MS.