NCT06095271

Brief 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 (EDA) or by improving patients' health-related quality of life.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
920

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Feb 2023May 2027

Study Start

First participant enrolled

February 5, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

October 10, 2023

Last Update Submit

May 9, 2025

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (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)

    24-months

  • 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

    24-months

Secondary Outcomes (9)

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

    12-months

  • EDA3 (evidence of disease activity)

    12-months

  • EQ-5D-5L

    12- and 24-months

  • Short form 36 (SF-36)

    12- and 24-months

  • relapses

    12- and 24-months

  • +4 more secondary outcomes

Other Outcomes (5)

  • Serious adverse events related to blood draw

    up to 42-months

  • Mortality

    up to 42-months

  • Adverse events related to immunosuppression

    up to 42-months

  • +2 more other outcomes

Study Arms (2)

sNfL monitoring

EXPERIMENTAL

6-monthly blood draw to measure sNfL

Diagnostic Test: serum Neurofilament Filament Light chain (sNfL) monitoring

Usual care

NO INTERVENTION

SMSC usual care

Interventions

serum Neurofilament Filament Light chain (sNfL) monitoringDIAGNOSTIC_TEST

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

sNfL monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital Basel

Basel, Canton of Basel-City, CH-4031, Switzerland

Location

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Inselspital Bern

Bern, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Ospedale Regionale di Lugano, sede Civico

Lugano, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 39261900DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Özgür Yaldizli, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

February 5, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations

CH(8)