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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095271
• Other study ID #: MultiSCRIPT-Cycle 1
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2023
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Özgür Yaldizli, MD
• Phone: 0615565554
• Email: oezguer.yaldizli[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 915
• Est. completion date: May 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Diagnostic Test:
• serum Neurofilament Filament Light chain (sNfL) monitoring
the intervention consist of a blood draw and providing the sNfL information to the treating physician

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	University Hospital Basel	Basel	Basel Stadt
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	Saint-Gall
Switzerland	UniversitätsSpital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serious adverse events related to blood draw		up to 42-months
Other	Mortality		up to 42-months
Other	Adverse events related to immunosuppression		up to 42-months
Other	Occurrence of relapses in patients previously stable	according to McDonald criteria	up to 42-months
Other	Disability worsening in patients previously stable	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.	up to 42-months
Primary	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
Primary	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	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	12-months
Secondary	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)	12-months
Secondary	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	12- and 24-months
Secondary	Short form 36 (SF-36)	contained in the MSQoL-54 questionnaire. The lower the score the more disability.	12- and 24-months
Secondary	relapses	according to McDonald criteria	12- and 24-months
Secondary	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.	12- and 24-months
Secondary	New/enlarging T2w lesions	MRI imaging	12- and 24-months
Secondary	T1w contrast enhancing lesions	MRI imaging	12- and 24-months
Secondary	Amount of immunosuppressive/immunomodulatory drug treatment		12- and 24-months