Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095271
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-10-10
Brief Title:
MultiSCRIPT-Cycle 1 Personalized Medicine in Multiple Sclerosis - Pragmatic Platform Trial Embedded Within the SMSC
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RRMS 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 eg 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 57 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 ie 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
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 eg 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 57 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None