Monitoring Multiple Sclerosis Patients After Treatment Changes
Official title: Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis
Run by Heinrich-Heine University, Duesseldorf · NCT06461481 · Data updated 2026-11-12
This study is testing how well different monitoring methods, like smartwatches and apps, can help keep track of people with Multiple Sclerosis after they change or stop their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Düsseldorf) |
| Status | Recruiting |
| Started | June 15, 2024 |
| Main results expected | October 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 3, 2024 |
| Trial ID | NCT06461481 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with relapsing-remitting Multiple Sclerosis (RRMS) who have recently de-escalated or discontinued their immunotherapy.
✕Probably not a fit
Patients with acute MS relapses, psychiatric comorbidities, or those diagnosed with progressive forms of MS may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with Multiple Sclerosis (MS) who have either de-escalated or discontinued their immunotherapy. It aims to closely monitor these patients using clinical assessments, digital tools, and serological biomarkers to detect any signs of disease progression or activity. The study will evaluate the effectiveness of various monitoring methods, including smartwatch-based measurements and app-based assessments, to improve understanding of individual disease courses after treatment changes. By analyzing these data, the study seeks to provide insights into the best practices for follow-up care in MS patients post-treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring strategies for MS patients, potentially reducing the risks associated with long-term immunotherapy.
How similar studies have gone: While there is ongoing research in monitoring MS patients, this specific approach combining digital tools and serological markers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where it's running
-
Heinrich-Heine University, Duesseldorf
Düsseldorf, Germany Recruiting
Study contacts
- Principal investigator: Marc Günter Pawlitzki, PD Dr. med. — Heinrich-Heine University, Duesseldorf
- Study coordinator: Marc Günter Pawlitzki, PD Dr. med.
- Email: MarcGuenter.Pawlitzki@med.uni-duesseldorf.de
- Phone: +49 02118117887
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.