Clinical trial NCT06095271: MultiSCRIPT-Cycle 1: Personalized Medicine in Multiple Sclerosis - Pragmatic Platform Trial Embedded Within the SMSC
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: EDA3 (evidence of disease activity)
timeFrame: 24-months
measure: Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
timeFrame: 24-months
Secondary outcomes:
measure: Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
timeFrame: 12-months
measure: EDA3 (evidence of disease activity)
timeFrame: 12-months
measure: EQ-5D-5L
timeFrame: 12- and 24-months
measure: Short form 36 (SF-36)
timeFrame: 12- and 24-months
measure: relapses
timeFrame: 12- and 24-months
measure: disability worsening
timeFrame: 12- and 24-months
measure: New/enlarging T2w lesions
timeFrame: 12- and 24-months
measure: T1w contrast enhancing lesions
timeFrame: 12- and 24-months
measure: Amount of immunosuppressive/immunomodulatory drug treatment
timeFrame: 12- and 24-months
Other outcomes:
measure: Serious adverse events related to blood draw
timeFrame: up to 42-months
measure: Mortality
timeFrame: up to 42-months
measure: Adverse events related to immunosuppression
timeFrame: up to 42-months
measure: Occurrence of relapses in patients previously stable
timeFrame: up to 42-months
measure: Disability worsening in patients previously stable
timeFrame: up to 42-months
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, sede Civico
city: Saint-Gall
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Özgür Yaldizli, MD
role: PRINCIPAL_INVESTIGATOR
References: