1University Hospital Zürich, Rämistrasse, Zürich, Switzerland2Royal Holloway, University of London, Egham, Surrey, UK3Foundation IRCCS Neurological Institute C. Besta, Milano, Italy4Université Bordeaux-Segalen, France5Centre Hospitalier-Universitaire of Bordeaux, France6Orbis Medisch Centrum, Sittard, The Netherlands7Karolinska Institutet, Stockholm, Sweden8University of Newcastle, University Drive, Callaghan, Australia9Division of Neurology, St Michael’s Hospital, University of Toronto, Toronto, ON, Canada10Department of Neurology-Neuroimmunology, Multiple Sclerosis of Catalonia (Cemcat), Vall d’Hebron University Hospital, Vall d’Hebron, Barcelona, Spain11Merck KGaA, Darmstadt, Germany
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Authors Disclaimer: http://medpub-poster.merckgroup.com/ABN2018DISC_CLARIFY.pdfBackgroundRelapsing multiple sclerosis (RMS) negatively affects health-related quality of life (HRQoL).ObjectiveAn open-label, single-arm, exploratory Phase IV study in centres in Europe and Australia will assess HRQoL in RMS patients receiving CT 3.5 mg/kg (CT3.5).MethodsEligible patients will receive CT 3.5 (cumulative) over 2 years. HRQoL (Multiple Sclerosis Quality of Life-54 [MSQoL-54]) and other patient-reported outcomes (Fatigue Severity Scale; Hospital Anxiety and Depression Scale; Treatment Satisfaction Questionnaire for Medication v1.4) will be assessed at baseline, and at 6, 12, 24 months.Other outcomes include AEs, MRI measures (T1 Gd+ lesions, T2 lesions, brain atrophy), number of relapses, and disability/functioning measures (EDSS; 9-Hole Peg Test; Timed 25-Foot Walk and Brief International Cognitive Assessment for Multiple Sclerosis). The sample size estimation is based on the power to detect a mean difference of 5 points in MSQoL-54 composite score at 24 months vs baseline.ResultsThe study aims to recruit 356 adults with RMS by 2019. Final data are anticipated in 2022.ConclusionsThis study will explore the effects of CT on HRQoL outcomes, and describe the effects of CT on treatment satisfaction and disability/functioning.Disclosure statementThe trial is sponsored by Merck KGaA, Darmstadt, Germany.