Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461481
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-25
Brief Title:
Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SAFEGUIDE-MS
Brief Summary:
The study will attempt to closely analyze Multiple Sclerosis MS patients after de-escalating or discontinuation of immunotherapy using clinical monitoring as well as digital and serological biomarkers in order to detect clinical progression or disease activity As this is an observational study it aims to closely follow-up on patients where the clinical decision to de-escalate or end treatment has been independently made Specifically we want to find out to what extent patients will show increased disease activity after de-escalationdiscontinuation from high-efficacy treatment HET and which measurement method clinical digital serological retrospectively reflects the disease activity most closely or detects it most sensitively
Detailed Description:
Due to the increasing scientific efforts in recent years a variety of HET are now available for patients with MS In addition to long-term clinical assessment monitoring by means of magnetic resonance imaging MRI has also become increasingly established No evidence of disease activity under appropriate immunotherapy has thus been defined in a wide variety of concepts using clinical and MRI parameters These medical achievements have positively influenced the natural course of MS especially by significantly reducing the relapse activity In contrast however the risk of potential complications under long-term immunotherapy should not be underestimated This concerns in particular infection risks but also an increased malignancy risk for various mostly highly effective immunotherapies
Therefore the question increasingly arises in clinical practice as to what extent HET should be continued or should be de-escalated in case of long-term disease course As patients and doctors take clinical decision to de-escalate their therapies often after many years of little or even no disease activity the central question of how to best monitor patients subsequently remains Digital smartwatch-based measurements or app-based regular assessments could add high-frequency real-world data to the picture and thus improve the understanding of individual disease courses Additionally novel serological markers to detect neuronal damage are becoming more widely available Consequently this study aims to evaluate different digital measurements and blood-based analyses to monitor disease activity in MS patients which have independently with their treating physicians decided to discontinue or de-escalate their disease-modifying treatment of MS
Data captured by the used smartwatches Withings Scanwatch includes activity-related data step count minutes in certain intensity levels basic cardiovascular measurements such as heart rate and sleep-related data total time asleep sleep efficiency and quality etc Blood-based measurements include serum neurofilament-light-chain sNfL glial fibrillary acidic protein GFAP and proteomic data The investigators will attempt to closely analyze MS patients after de-escalating or discontinuation of immunotherapy using digital and serological biomarkers in order to detect possible increased disease activity In addition to clinical assessment structural MRI examinations will be optionally conducted in patients from core center at baseline and in month 12 and 24 Measurement parameters from clinical MRI examinations lesion load are also taken into account from the other study centers In addition to that patients from core center will undergo an Optical coherence tomography OCT measurement OCT is a non-invasive interferometric method that allows for detailed visualization of retinal morphology and is known to reveal abnormalities in various central nervous system CNS disorders Data will be collected for a 24-month prospective period
Therefore the question increasingly arises in clinical practice as to what extent HET should be continued or should be de-escalated in case of long-term disease course As patients and doctors take clinical decision to de-escalate their therapies often after many years of little or even no disease activity the central question of how to best monitor patients subsequently remains Digital smartwatch-based measurements or app-based regular assessments could add high-frequency real-world data to the picture and thus improve the understanding of individual disease courses Additionally novel serological markers to detect neuronal damage are becoming more widely available Consequently this study aims to evaluate different digital measurements and blood-based analyses to monitor disease activity in MS patients which have independently with their treating physicians decided to discontinue or de-escalate their disease-modifying treatment of MS
Data captured by the used smartwatches Withings Scanwatch includes activity-related data step count minutes in certain intensity levels basic cardiovascular measurements such as heart rate and sleep-related data total time asleep sleep efficiency and quality etc Blood-based measurements include serum neurofilament-light-chain sNfL glial fibrillary acidic protein GFAP and proteomic data The investigators will attempt to closely analyze MS patients after de-escalating or discontinuation of immunotherapy using digital and serological biomarkers in order to detect possible increased disease activity In addition to clinical assessment structural MRI examinations will be optionally conducted in patients from core center at baseline and in month 12 and 24 Measurement parameters from clinical MRI examinations lesion load are also taken into account from the other study centers In addition to that patients from core center will undergo an Optical coherence tomography OCT measurement OCT is a non-invasive interferometric method that allows for detailed visualization of retinal morphology and is known to reveal abnormalities in various central nervous system CNS disorders Data will be collected for a 24-month prospective period
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