Measuring silent disease progression in Multiple Sclerosis
Official title: Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
Run by Heinrich-Heine University, Duesseldorf · NCT06501950 · Data updated 2026-11-12
This study is trying to see how Multiple Sclerosis progresses in patients on monoclonal antibody treatments, even when they aren't having relapses, by tracking their health over time with various tests and technology.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 77 (estimated) |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Drugs / interventions | Natalizumab, Ofatumumab, Ocrelizumab |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | June 20, 2024 |
| Main results expected | October 2027 |
| Study ends | December 2027 |
| Registry record updated | July 15, 2024 |
| Trial ID | NCT06501950 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with relapsing remitting or primary progressive MS who are currently treated with monoclonal antibodies and have an EDSS score of 7.0 or lower.
✕Probably not a fit
Patients experiencing an acute MS relapse or those with significant comorbidities that impair study participation 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 aims to examine disease progression in patients with Multiple Sclerosis (MS) who are treated with monoclonal antibodies, focusing on progression independent of relapses. Participants will undergo clinical evaluations every six months and may receive MRI scans annually, alongside blood biomarker tests. Additionally, digital health technologies will be utilized to continuously collect data on movement, sleep, and cognition. The study seeks to identify the percentage of patients experiencing slow disease progression despite treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and understanding of silent disease progression in MS, potentially enhancing patient care.
How similar studies have gone: While the approach of using digital health technologies in MS monitoring is gaining traction, this specific study's focus on silent disease progression is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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University Hospital Düsseldorf, Department of Neurology
Düsseldorf, North Rhine-Westphalia, 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.