MultiSCRIPT-Cycle 1: Personalized Medicine in Multiple Sclerosis - Pra

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

Running, not recruitingNot a drug-phase studyRelapsing MSNCT06095271

What it found

Still running

No result yet.

What was tested

Treatment tested

  • serum Neurofilament Filament Light chain (sNfL) monitoring

What it measured

Main measures

  • EDA3 (evidence of disease activity)

    24-months

    Disability progressionRelapsesMRI lesions

  • Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument

    24-months

    Quality of life (reported by participants)

Other measures (9)

  • Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument

    12-months

    Quality of life (reported by participants)

  • EDA3 (evidence of disease activity)

    12-months

    Disability progressionRelapsesMRI lesions

  • EQ-5D-5L

    12- and 24-months

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Short form 36 (SF-36)

    12- and 24-months

    Quality of life (reported by participants)

  • relapses

    12- and 24-months

    Relapses

  • disability worsening

    12- and 24-months

    Disability progression

  • New/enlarging T2w lesions

    12- and 24-months

    MRI lesions

  • T1w contrast enhancing lesions

    12- and 24-months

    MRI lesions

  • Amount of immunosuppressive/immunomodulatory drug treatment

    12- and 24-months

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

* Diagnosis of RRMS according to the most recent McDonald criteria (2017) for at least one year * Have already consented to take part in the SMSC * Age 18 years old or older * Able and willing to consent

Exclusion criteria

* Inclusion or planned inclusion in another clinical trial that determines the drug therapy for MS for the purpose of research as these patients are most likely not following the SMSC usual care.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is a randomized pragmatic clinical trial fully embedded in the Swiss Multiple Sclerosis Cohort to assess whether sNfL biomarker monitoring improves patient-relevant outcomes and care of patients with relapsing-remitting (RR)MS by either increasing the proportion of patients with no evidence of disease activity (EDA) or by improving patients' health-related quality of life.

Papers

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History

    1. Started

      Feb 2023

    2. Main results due

      Nov 2026

    3. Finished

      May 2027

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