Evidence map›Paper›PMID 39261900›Full record

ArticleTrials2024

MultiSCRIPT-Cycle 1-a pragmatic trial embedded within the Swiss Multiple Sclerosis Cohort (SMSC) on neurofilament light chain monitoring to inform personalized treatment decisions in multiple sclerosis: a study protocol for a randomized clinical trial.

Perrine Janiaud, Chiara Zecca, Anke Salmen, Pascal Benkert, Sabine Schädelin, Annette Orleth, Lilian Demuth, Aleksandra Maleska Maceski, Cristina Granziera, Johanna Oechtering and 19 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06095271 (A Multicenter, Randomized Pragmatic Platform Trial Embedded Within the Swiss Multiple Sclerosis Cohort), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06095271 naactive not recruitingnot on this map

A Multicenter, Randomized Pragmatic Platform Trial Embedded Within the Swiss Multiple Sclerosis Cohort (SMSC) on Neurofilament Light Chain Monitoring Added to Usual Care to Inform Personalized Treatment Decisions in Multiple Sclerosis

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2023 to 2027Enrolled920ConditionsMultiple Sclerosis, Relapsing-RemittingArmsserum Neurofilament Filament Light chain (sNfL) monitoring
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Perrine JaniaudResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Chiara ZeccaNeurology Clinic Lugano, Neurocenter of Southern Switzerland, Lugano, MS Center, Switzerland.
Anke SalmenDepartment of Neurology, Ruhr-University Bochum, St. Josef-Hospital, Bochum, Germany.
Pascal BenkertDepartment of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Sabine SchädelinDepartment of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Annette OrlethResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Lilian DemuthResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Aleksandra Maleska MaceskiResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Cristina GranzieraResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Johanna OechteringResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
David LeppertResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Tobias DerfussResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Lutz AchtnichtsDepartment of Neurology, Cantonal Hospital Aarau, Aarau, Switzerland.
Oliver FindlingDepartment of Neurology, Cantonal Hospital Aarau, Aarau, Switzerland.
Patrick RothDepartment of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
Patrice LaliveDivision of Neurology, Department of Clinical Neurosciences, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Marjolaine UginetDivision of Neurology, Department of Clinical Neurosciences, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Stefanie MüllerDepartment of Neurology, Cantonal Hospital St, Gallen, St. Gallen, Switzerland.
Caroline PotService of Neurology, Department of Clinical Neurosciences, Lausanne University Hospital (CHUV) and, University of Lausanne, Lausanne, Switzerland.
Robert HoepnerDepartment of Neurology, Bern University Hospital and University of Bern, Bern, Switzerland.
Giulio DisantoNeurology Clinic Lugano, Neurocenter of Southern Switzerland, Lugano, MS Center, Switzerland.
Claudio GobbiNeurology Clinic Lugano, Neurocenter of Southern Switzerland, Lugano, MS Center, Switzerland.
Leila RooshenasBristol Population Health Science Institute, University of Bristol, Bristol, UK.
Matthias SchwenkglenksHealth Economics Facility, Department of Public Health, University of Basel, Basel, Switzerland.
Mark J LambirisHealth Economics Facility, Department of Public Health, University of Basel, Basel, Switzerland.
Ludwig KapposResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Jens Kuhle *Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Özgür Yaldizli *Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland.
Lars G Hemkens *Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland. lars.hemkens@usb.ch.ORCID http://orcid.org/0000-0002-3444-1432

Funding

Swiss National Science Foundation 205806
6 · The paper itself

Abstract

backgroundTreatment decisions for persons with relapsing-remitting multiple sclerosis (RRMS) rely on clinical and radiological disease activity, the benefit-harm profile of drug therapy, and preferences of patients and physicians. However, there is limited evidence to support evidence-based personalized decision-making on how to adapt disease-modifying therapy treatments targeting no evidence of disease activity, while achieving better patient-relevant outcomes, fewer adverse events, and improved care. Serum neurofilament light chain (sNfL) is a sensitive measure of disease activity that captures and prognosticates disease worsening in RRMS. sNfL might therefore be instrumental for a patient-tailored treatment adaptation. We aim to assess whether 6-monthly sNfL monitoring in addition to usual care improves patient-relevant outcomes compared to usual care alone.

methodsPragmatic multicenter, 1:1 randomized, platform trial embedded in the Swiss Multiple Sclerosis Cohort (SMSC). All patients with RRMS in the SMSC for ≥ 1 year are eligible. We plan to include 915 patients with RRMS, randomly allocated to two groups with different care strategies, one of them new (group A) and one of them usual care (group B). In group A, 6-monthly monitoring of sNfL will together with information on relapses, disability, and magnetic resonance imaging (MRI) inform personalized treatment decisions (e.g., escalation or de-escalation) supported by pre-specified algorithms. In group B, patients will receive usual care with their usual 6- or 12-monthly visits. Two primary outcomes will be used: (1) evidence of disease activity (EDA3: occurrence of relapses, disability worsening, or MRI activity) and (2) quality of life (MQoL-54) using 24-month follow-up. The new treatment strategy with sNfL will be considered superior to usual care if either more patients have no EDA3, or their health-related quality of life increases. Data collection will be embedded within the SMSC using established trial-level quality procedures. DISCUSSION: MultiSCRIPT aims to be a platform where research and care are optimally combined to generate evidence to inform personalized decision-making in usual care. This approach aims to foster better personalized treatment and care strategies, at low cost and with rapid translation to clinical practice.

trial registrationClinicalTrials.gov NCT06095271. Registered on October 23, 2023.

Indexed as

BiomarkersMultiple Sclerosis, Relapsing-RemittingNeurofilament ProteinsPragmatic Clinical Trials as TopicPrecision MedicineAdaptive Clinical Trials as TopicClinical Decision-MakingDisability EvaluationDisease ProgressionHumansMulticenter Studies as TopicPredictive Value of TestsQuality of LifeRandomized Controlled Trials as TopicSwitzerlandTime FactorsBiomarkersneurofilament protein LNeurofilament Proteins

Identifiers

PMID39261900
PMCPMC11391827

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.