NCT06461481Recruiting
Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 3 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 25 Apr 2024
- Start date
- 15 Jun 2024
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Diseases
- Multiple sclerosis
- NCT number
- NCT06461481
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 Jun 2024 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Diagnosis of primary or secondary progressive MS
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heinrich-Heine University, Duesseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
Related publications
- Brain age gap in multiple sclerosis: associated with disability but independent of serum biomarkers.Ther Adv Neurol Disord · 2026 · PMID 42368888
This page is information, not medical advice. Discuss any trial with your doctor.