Prospective study validating a multidimensional treatment decision score predicting the 24-month outcome in untreated patients with clinically isolated syndrome and early relapsing–remitting multiple sclerosis, the ProVal-MS study

Antonios Bayas, Ulrich Mansmann, Begum Irmak Ön, Verena S. Hoffmann, Achim Berthele, Mark Mühlau, Markus C. Kowarik, Markus Krumbholz, Makbule Senel, Verena Steuerwald, Markus Naumann, Julia Hartberger, Martin Kerschensteiner, Eva Oswald, Christoph Ruschil, Ulf Ziemann, Hayrettin Tumani, Ioannis Vardakas, Fady Albashiti, Frank KramerIñaki Soto-Rey, Helmut Spengler, Gerhard Mayer, Hans Armin Kestler, Oliver Kohlbacher, Marlien Hagedorn, Martin Boeker, Klaus Kuhn, Stefan Buchka, Florian Kohlmayer, Jan S. Kirschke, Lars Behrens, Hanna Zimmermann, Benjamin Bender, Nico Sollmann, Joachim Havla, Bernhard Hemmer

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: In Multiple Sclerosis (MS), patients´ characteristics and (bio)markers that reliably predict the individual disease prognosis at disease onset are lacking. Cohort studies allow a close follow-up of MS histories and a thorough phenotyping of patients. Therefore, a multicenter cohort study was initiated to implement a wide spectrum of data and (bio)markers in newly diagnosed patients. Methods: ProVal-MS (Prospective study to validate a multidimensional decision score that predicts treatment outcome at 24 months in untreated patients with clinically isolated syndrome or early Relapsing–Remitting-MS) is a prospective cohort study in patients with clinically isolated syndrome (CIS) or Relapsing–Remitting (RR)-MS (McDonald 2017 criteria), diagnosed within the last two years, conducted at five academic centers in Southern Germany. The collection of clinical, laboratory, imaging, and paraclinical data as well as biosamples is harmonized across centers. The primary goal is to validate (discrimination and calibration) the previously published DIFUTURE MS-Treatment Decision score (MS-TDS). The score supports clinical decision-making regarding the options of early (within 6 months after study baseline) platform medication (Interferon beta, glatiramer acetate, dimethyl/diroximel fumarate, teriflunomide), or no immediate treatment (> 6 months after baseline) of patients with early RR-MS and CIS by predicting the probability of new or enlarging lesions in cerebral magnetic resonance images (MRIs) between 6 and 24 months. Further objectives are refining the MS-TDS score and providing data to identify new markers reflecting disease course and severity. The project also provides a technical evaluation of the ProVal-MS cohort within the IT-infrastructure of the DIFUTURE consortium (Data Integration for Future Medicine) and assesses the efficacy of the data sharing techniques developed. Perspective: Clinical cohorts provide the infrastructure to discover and to validate relevant disease-specific findings. A successful validation of the MS-TDS will add a new clinical decision tool to the armamentarium of practicing MS neurologists from which newly diagnosed MS patients may take advantage. Trial registration ProVal-MS has been registered in the German Clinical Trials Register, `Deutsches Register Klinischer Studien` (DRKS)—ID: DRKS00014034, date of registration: 21 December 2018; https://drks.de/search/en/trial/DRKS00014034

Original languageEnglish
Article number15
JournalNeurological Research and Practice
Volume6
Issue number1
DOIs
StatePublished - Dec 2024
Externally publishedYes

Keywords

  • Clinical trial
  • Clinically isolated syndrome
  • Data integration
  • Multiple sclerosis
  • Prospective cohort
  • Routine data
  • Treatment decision
  • Validation

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