Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis

NCT06461481 | Recruiting

• 1 other identifier: SGMS_1.0
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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-escalation/discontinuation from high-efficacy treatment (HET) and which measurement method (clinical, digital, serological) retrospectively reflects the disease activity most closely or detects it most sensitively.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Follow-Up

Outcome Measures

Primary Outcomes (1)

• Percentage of disease activity, measured by loss of NEDA at month 24

  According to NEDA-3 (Giovannoni et al., 2015) indicated by relapse, EDSS or cerebral magnetic resonance imaging (MRI) activity.

  Baseline up to 24 months

Secondary Outcomes (34)

• EDSS: Change From Baseline in Expanded Disability Status Scale (EDSS) Score

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score - Component Paced Auditory Serial Addition Test

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score - Component 9-hole peg test

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score - Component Timed 25-foot walk (T25FW)

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

Study Arms (2)

Core center

In addition to clinical assessment, 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.

Device: Withings Scanwatch

Extended cohort

Clinical assessment will be conducted in patients from extended cohort at baseline and in month 6, 12, 18 and 24.

Interventions

Withings Scanwatch DEVICE

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.).

Core center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 MS patients after treatment de-escalation/discontinuation

You may qualify if:

• Diagnosed RRMS according to 2017 revised McDonald criteria 12
• De-escalation of high-efficacy treatment or discontinuation of lower efficacy disease modifying therapy (DMT)
• Own a smartphone (only core centre) EDSS \<7.0
• able to handle a smartphone (only core centre)

You may not qualify if:

• Patients with an acute MS relapse and/or a history of intravenous corticosteroid treatment or immunoadsorption within past six weeks.
• Any comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementia. Decision will be made at investigators discretion.
• Diagnosis of primary or secondary progressive MS

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Heinrich-Heine University, Duesseldorf

Düsseldorf, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marc Günter Pawlitzki, PD Dr. med.

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Günter Pawlitzki, PD Dr. med.

CONTACT

+49 02118117887; MarcGuenter.Pawlitzki@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: June 17, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)