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Multiple Sclerosis, Relapsing-RemittingNCT06095271

MultiSCRIPT-Cycle 1: Personalized Medicine in Multiple Sclerosis - Pragmatic Platform Trial Embedded Within the SMSC

A study testing serum Neurofilament Filament Light chain (sNfL) monitoring in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
serum Neurofilament Filament Light chain (sNfL) monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
920 participants
Where
8 sitesSwitzerland
Study dates
5 Feb 2023to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Switzerland8 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • University Hospital Basel

    Basel, Canton of Basel-City, CH-4031

  • Inselspital Bern

    Bern

  • Hôpitaux Universitaires de Genève

    Geneva

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

  • Ospedale Regionale di Lugano, sede Civico

    Lugano

  • Kantonsspital St.Gallen

    Sankt Gallen

  • UniversitätsSpital Zürich

    Zurich

Other trials in Switzerland

About this study

Official title: 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

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.

Read the detailed description

The course of multiple sclerosis (MS) is highly heterogenous with a large variability in symptoms, severity and response to treatment. A large majority of persons with MS are treated with disease modifying therapies (DMTs). DMTs can dramatically reduce even almost suppress relapses and occurrence of new lesions in magnetic resonance imaging (MRI) by weakening the immune system but which in turn may cause side effects such as opportunistic infections with prolonged treatment duration and intensity of the immunosuppression.

A more personalized approach to MS therapy is urgently needed to treat patients as little as possible but as much as necessary and at the right time. Such tailored strategies cannot be made without detailed information on treatment response and disease activity. Levels sNfL, which is released in the blood following neuroaxonal damage, has been shown to be associated with future MS disease activity, disability worsening, MRI activity and treatment response. sNfL might therefore be helpful for a patient-tailored treatment adaptation (e.g., escalation or de-escalation) ensuring disease stability, fewer adverse events and better quality of life. While sNfL is increasingly used as a marker of treatment response, its use in routine care is not yet widely established.

The SMSC is an observational study across 8 Swiss leading MS centers including >1600 participants with MS with a median follow-up of >5.7 years. The MultiSCRIPT project aims to use this real-world data infrastructure to systematically evaluate patient-relevant benefits resulting from innovations in MS patient care.

MultiSCRIPT goes beyond a unique trial but aims to be a sustainable learning system in which accumulating data from successive pragmatic randomized trials (i.e., learning cycles) enable the continuous generation of new hypotheses on how treatment and care strategies can be further personalized to treat patients as little as possible but as much as necessary at the right time. By being nested within the already existing and ongoing SMSC, this research infrastructure embedded in clinical care offers an unique opportunity to efficiently conduct a nationwide real-life evaluation of new care strategies, at low costs, and fostering evaluation and direct translation of effective innovations into usual care to improve patient outcome and quality of life. MultiSCRIPT-Cycle 1 is the first learning cycle.

Being tested
serum Neurofilament Filament Light chain (sNfL) monitoring
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serum Neurofilament Filament Light chain (sNfL) monitoringDiagnostic test

    the intervention consist of a blood draw and providing the sNfL information to the treating physician

Study groups in NCT06095271
Study groupRoleWhat they receive
sNfL monitoringExperimental6-monthly blood draw to measure sNfL
Receives: Diagnostic Test: serum Neurofilament Filament Light chain (sNfL) monitoring
Usual careNo interventionSMSC usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EDA3 (evidence of disease activity)

    number of participant with a relapse or disability worsening (measured by Expanded Disability Status Scale (EDSS)) or disease activity on MRI imaging (new/enlarging T2 weighted lesions or T1 weighted contrast enhancing lesion on cranial or spinal cord MRI)

    Measured: 24-months

  2. Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument

    The summary scores are the physical health composite summary and the mental health composite summary. A higher score indicates improved quality of life

    Measured: 24-months

Secondary outcomes (9)

  1. Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument

    The summary scores are the physical health composite summary and the mental health composite summary. A higher score indicates improved quality of life

    Measured: 12-months

  2. EDA3 (evidence of disease activity)

    number of participant with a relapse or disability worsening (measured by Expanded Disability Status Scale (EDSS)) or disease activity on MRI imaging (new/enlarging T2 weighted lesions or T1 weighted contrast enhancing lesion on cranial or spinal cord MRI)

    Measured: 12-months

  3. EQ-5D-5L

    The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and includes an overall visual analog scale

    Measured: 12- and 24-months

  4. Short form 36 (SF-36)

    contained in the MSQoL-54 questionnaire. The lower the score the more disability.

    Measured: 12- and 24-months

  5. relapses

    according to McDonald criteria

    Measured: 12- and 24-months

  6. disability worsening

    measured by Expanded Disability Status Scale (EDSS). The EDSS ranges from 0 to 10. The greater the level of disability, the higher is the score.

    Measured: 12- and 24-months

  7. New/enlarging T2w lesions

    MRI imaging

    Measured: 12- and 24-months

  8. T1w contrast enhancing lesions

    MRI imaging

    Measured: 12- and 24-months

  9. Amount of immunosuppressive/immunomodulatory drug treatment

    Measured: 12- and 24-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start5 Feb 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06095271
Sponsor's protocol ID
MultiSCRIPT-Cycle 1
Status last verified
May 2025
First submitted
10 Oct 2023
Last updated
11 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Janiaud P, Zecca C, Salmen A, Benkert P, Schadelin S, Orleth A, Demuth L, Maceski AM, Granziera C, Oechtering J, Leppert D, Derfuss T, Achtnichts L, Findling O, Roth P, Lalive P, Uginet M, Muller S, Pot C, Hoepner R, Disanto G, Gobbi C, Rooshenas L, Schwenkglenks M, Lambiris MJ, Kappos L, Kuhle J, Yaldizli O, Hemkens LG. 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. Trials. 2024 Sep 11;25(1):607. doi: 10.1186/s13063-024-08454-6.

    PubMed 39261900

Questions about this trial

What is this clinical trial studying?

A study testing serum Neurofilament Filament Light chain (sNfL) monitoring in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EDA3 (evidence of disease activity) (time frame: 24-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06095271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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