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THUR 174 The magnify-ms study: mavenclad® tablets in active rms
  1. N de Stefano1,
  2. A Achiron2,
  3. F Barkhof3,4,
  4. A Chan5,
  5. T Derfuss6,
  6. S Hodgkinson7,
  7. L Leocani8,
  8. X Montalban9,10,
  9. A Prat11,
  10. K Schmierer12,13,
  11. F Sellebjerg14,
  12. P Vermersch15,
  13. H Wiendl16,
  14. B Keller17,
  15. S Roy18
  16. on behalf of the MAGNIFY-MS study group
  1. 1Department of Neurological and Behavioural Sciences, University of Siena, Siena, Italy
  2. 2Multiple Sclerosis Center, Sheba Academic Medical Center, Ramat Gan, Israel
  3. 3Department of Radiology, VU University Medical Center, Amsterdam, The Netherlands
  4. 4UCL Institute of Neurology, London, UK
  5. 5Bern University Hospital, University of Bern, Bern, Switzerland
  6. 6Department of Neurology, University Hospital Basel, Basel, Switzerland
  7. 7Ingham Institute for Applied Medical Research, University of New South Wales Medicine, Sydney, Australia
  8. 8Experimental Neurophysiological Unit, Vita-Salute San Raffaele University, Milan, Italy
  9. 9Division of Neurology, St Michael’s Hospital, University of Toronto, Toronto, Canada
  10. 10Department of Neurology-Neuroimmunology, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d’Hebron, Barcelona, Spain
  11. 11Department of Neurosciences, Université de Montréal, Montréal, Canada
  12. 12The Blizard Institute (Neuroscience), Barts and The London School of Medicine & Dentistry, Queen Mary University of London, London, UK
  13. 13The Royal London Hospital, Barts Health NHS Trust, London, UK
  14. 14Danish MS Center, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark
  15. 15University de Lille, CHU Lille, LIRIC-INSERM U995, FHU Imminent, Lille, France
  16. 16Department of Neurology, University of Münster, Münster, Germany
  17. 17Merck KGaA, Darmstadt, Germany
  18. 18Merck, Aubonne, Switzerland

Abstract

Authors Disclaimer: http://medpub-poster.merckgroup.com/ABN2018DISC_MAGNIFY.pdf

Background Cladribine tablets (CT) improve clinical and MRI outcomes in patients with active RMS, with significant differences versus placebo after 24 weeks.

Objective Describe the design of a study to assess the onset of CT’s clinical and MRI effects in patients with active RMS.

Methods MAGNIFY-MS is a 2 year prospective Phase IV trial (including approximately 100 centres in Europe). Eligible patients will receive two years treatment with CT 3.5 mg/kg cumulative dose. Frequent MRI assessments (including lesion count, lesion volume, brain volume and MTR) will be performed at screening, baseline and 1, 2, 3, 6, 12, 15, 18 and 24 months. Various T- and B-cell subtype counts and functional profiling (eg cytokine production) will be assessed. Clinical outcomes will include changes in cognition (SDMT), disability (EDSS/KFS, 9HPT, T25FW), relapses, NEDA, NEDAP and safety at timepoints up to 24 months.

Results Aim recruit 300 patients. Primary endpoint: change in the count of combined unique active lesions at end of 6 months versus baseline. Final outcomes expected in 2021.

Conclusions MAGNIFY-MS will provide important information on the effects of CT, including early MRI changes, insights into effects on a range of disability and cognition markers, and detailed characterization of immune cell reconstitution.

Disclosure statement This study was sponsored by EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany (in the USA), and Merck Serono SA – Geneva, an affiliate of Merck KGaA Darmstadt, Germany (ROW).

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