Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
Recruiting · NCT06501950 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heinrich-Heine University, Duesseldorf
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
- Additional immunosuppression except of above mentioned monoclonal antibodies
- Pregnancy
Where it is running
1 location listed.
- University Hospital Düsseldorf, Department of Neurology - Düsseldorf, North Rhine-Westphalia, Germany