Actively Recruiting

Age: 18Years +
All Genders
NCT06501950

Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach

Led by Heinrich-Heine University, Duesseldorf · Updated on 2024-07-15

77

Participants Needed

1

Research Sites

179 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of relapsing remitting MS or primary progressive MS according to the 2017 McDonald criteria
  • Currently treated with monoclonal antibodies such as Natalizumab, Ofatumumab, or Ocrelizumab according to SmPC
  • Expanded Disability Status Scale (EDSS) score of 7.0 or less
Not Eligible

You will not qualify if you...

  • Acute MS relapse or intravenous corticosteroid treatment within the past six weeks
  • Any comorbid condition impairing understanding or completion of the study, including psychiatric disorders or dementia, as decided by the investigator
  • Additional immunosuppressive treatments other than the specified monoclonal antibodies
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Düsseldorf, Department of Neurology

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Actively Recruiting

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Research Team

M

Marc Günter Pawlitzki, PD Dr. med.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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