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

NCT ID: NCT06095271

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 920 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-05
• Study Completion Date: 2027-05-31

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.

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

sNfL monitoring

6-monthly blood draw to measure sNfL

Group Type: EXPERIMENTAL

serum Neurofilament Filament Light chain (sNfL) monitoring

Intervention Type: DIAGNOSTIC_TEST

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

Usual care

SMSC usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

serum Neurofilament Filament Light chain (sNfL) monitoring

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Özgür Yaldizli, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Kantonsspital Aarau

Aarau, , Switzerland

Inselspital Bern

Bern, , Switzerland

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Ospedale Regionale di Lugano, sede Civico

Lugano, , Switzerland

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

UniversitätsSpital Zürich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 39261900 (View on PubMed)

Other Identifiers

MultiSCRIPT-Cycle 1

Identifier Type: -

Identifier Source: org_study_id