Tracking Hidden Worsening in Multiple Sclerosis Patients Treated With Antibody Drugs
Follows adults with multiple sclerosis on antibody drugs using exams, scans, blood tests and smartphones.
Plain-language title generated from the registry record
Registry title: Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
Key facts
- Where
- Düsseldorf, GermanySee the site
Where in Germany
- University Hospital Düsseldorf, Department of NeurologyDüsseldorf, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heinrich-Heine University, Duesseldorf
- Trial code
- NCT06501950
- Record updated
- 15 July 2024
- Original description
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.Read full original descriptionShow less
Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
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.
Inclusion: 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.
Exclusion: Additional immunosuppression except of above mentioned monoclonal antibodies; 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; Pregnancy.