MultiSCRIPT-Cycle 1: Personalized Medicine in Multiple Sclerosis - Pragmatic Platform Trial Embedded Within the SMSC
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
serum Neurofilament Filament Light chain (sNfL) monitoring
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis, Relapsing-Remitting
Eligibility Criteria
Inclusion Criteria: Diagnosis of RRMS according to the most recent McDonald criteria (2017) for at least one year In the SMSC or followed in the Zurich MS center for at least one year 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.
Sites / Locations
- University Hospital Basel
- Kantonsspital Aarau
- Inselspital Bern
- Hôpitaux Universitaires de Genève
- Centre Hospitalier Universitaire Vaudois
- Ospedale Regionale di Lugano, sede Civico
- Kantonsspital St.Gallen
- UniversitätsSpital Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sNfL monitoring
Usual care
Arm Description
6-monthly blood draw to measure sNfL
SMSC usual care
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
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
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)
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
Short form 36 (SF-36)
contained in the MSQoL-54 questionnaire. The lower the score the more disability.
relapses
according to McDonald criteria
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.
New/enlarging T2w lesions
MRI imaging
T1w contrast enhancing lesions
MRI imaging
Amount of immunosuppressive/immunomodulatory drug treatment
Full Information
NCT ID
NCT06095271
First Posted
October 10, 2023
Last Updated
October 17, 2023
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT06095271
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
915 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sNfL monitoring
Arm Type
Experimental
Arm Description
6-monthly blood draw to measure sNfL
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
SMSC usual care
Intervention Type
Diagnostic Test
Intervention Name(s)
serum Neurofilament Filament Light chain (sNfL) monitoring
Intervention Description
the intervention consist of a blood draw and providing the sNfL information to the treating physician
Primary Outcome Measure Information:
Title
EDA3 (evidence of disease activity)
Description
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)
Time Frame
24-months
Title
Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
Description
The summary scores are the physical health composite summary and the mental health composite summary. A higher score indicates improved quality of life
Time Frame
24-months
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
Description
The summary scores are the physical health composite summary and the mental health composite summary. A higher score indicates improved quality of life
Time Frame
12-months
Title
EDA3 (evidence of disease activity)
Description
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)
Time Frame
12-months
Title
EQ-5D-5L
Description
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
Time Frame
12- and 24-months
Title
Short form 36 (SF-36)
Description
contained in the MSQoL-54 questionnaire. The lower the score the more disability.
Time Frame
12- and 24-months
Title
relapses
Description
according to McDonald criteria
Time Frame
12- and 24-months
Title
disability worsening
Description
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.
Time Frame
12- and 24-months
Title
New/enlarging T2w lesions
Description
MRI imaging
Time Frame
12- and 24-months
Title
T1w contrast enhancing lesions
Description
MRI imaging
Time Frame
12- and 24-months
Title
Amount of immunosuppressive/immunomodulatory drug treatment
Time Frame
12- and 24-months
Other Pre-specified Outcome Measures:
Title
Serious adverse events related to blood draw
Time Frame
up to 42-months
Title
Mortality
Time Frame
up to 42-months
Title
Adverse events related to immunosuppression
Time Frame
up to 42-months
Title
Occurrence of relapses in patients previously stable
Description
according to McDonald criteria
Time Frame
up to 42-months
Title
Disability worsening in patients previously stable
Description
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.
Time Frame
up to 42-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RRMS according to the most recent McDonald criteria (2017) for at least one year
In the SMSC or followed in the Zurich MS center for at least one year
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özgür Yaldizli, MD
Phone
0615565554
Ext
+41
Email
oezguer.yaldizli@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özgür Yaldizli, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lutz Achtnichts
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hoepner
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Lalive
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Pot-Kreis
Facility Name
Ospedale Regionale di Lugano, sede Civico
City
Lugano
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Zecca
Facility Name
Kantonsspital St.Gallen
City
Saint-Gall
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefanie Müller
Facility Name
UniversitätsSpital Zürich
City
Zürich
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Roth
12. IPD Sharing Statement
Learn more about this trial
MultiSCRIPT-Cycle 1: Personalized Medicine in Multiple Sclerosis - Pragmatic Platform Trial Embedded Within the SMSC
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