Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Düsseldorf, Department of Neurology
RECRUITING
Düsseldorf
Contact Information
Primary
Marc Günter Pawlitzki, PD Dr. med.
MarcGuenter.Pawlitzki@med.uni-duesseldorf.de
+49 02118117887
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2027-12
Participants
Target number of participants: 77
Treatments
Core centre
Persons that will be included by the core centre will be examined every 6 months by clinical testing, blood tests, and optical coherence tomography. A MRI will be conducted every 12 month. Additional digital monitoring using a smartwatch and smartphone ist optional.
Other study centre
Persons that will be included by the other study centre will be examined every 6 months by clinical testing and blood tests. Additional digital monitoring using a smartwatch and smartphone ist optional.
Related Therapeutic Areas
Sponsors
Leads: Heinrich-Heine University, Duesseldorf

This content was sourced from clinicaltrials.gov