NCT06501950Recruiting
Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
Source: ClinicalTrials.gov · Last updated 15 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This observational study wants to examine the disease progression independent of relapses in patients with Multiple Sclerosis (MS) that are treated with monoclonal antibodies. Participants will be clinically examined every 6 months and optionally receive a magnetic resonance imaging (MRI) every 12 months. The investigators will also take blood for blood biomarker tests with each clinical examination. Optionally, digital data can be continuously collected via smartphone and smartwatch. With this information the study will compare the results from clinical, digital, radiological, and blood-based tests with the disease progression the participants report themselves. This study aims to investigate what percentage auf patients with MS under antibody treatment experience a slow progression of the disease.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 77 (estimated)
- First submitted
- 20 Jun 2024
- Start date
- 20 Jun 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Diseases
- Multiple sclerosis
- NCT number
- NCT06501950
What you commit to
- Study type: Observational
- Planned participants: 77
- From 20 Jun 2024 to the primary completion date, Oct 2027
- 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.
Prior treatment
- Additional immunosuppression except of above mentioned monoclonal antibodies
Other illness
- Patients with an acute MS relapse and/or a history of intravenous corticosteroid treatment 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
- Pregnancy
Who the study is looking for
- Diagnosis of RRMS or PPMS according to the 2017 McDonald criteria
- Current treatment with monoclonal antibodies (including Natalizumab, Ofatumumab, Ocrelizumab) according to SmPC
- EDSS ≤7.0
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Düsseldorf, Department of Neurology 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.