Actively Recruiting
Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis
Led by Heinrich-Heine University, Duesseldorf · Updated on 2024-07-03
150
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will attempt to closely analyze Multiple Sclerosis (MS) patients after de-escalating or discontinuation of immunotherapy using clinical monitoring as well as digital and serological biomarkers in order to detect clinical progression or disease activity. As this is an observational study, it aims to closely follow-up on patients where the clinical decision to de-escalate or end treatment has been independently made. Specifically, we want to find out to what extent patients will show increased disease activity after de-escalation/discontinuation from high-efficacy treatment (HET) and which measurement method (clinical, digital, serological) retrospectively reflects the disease activity most closely or detects it most sensitively.
CONDITIONS
Official Title
Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed relapsing-remitting multiple sclerosis (RRMS) according to 2017 revised McDonald criteria
- Have reduced high-efficacy treatment or stopped lower efficacy disease modifying therapy
- Own a smartphone (only for patients at the core center)
- Able to use a smartphone (only for patients at the core center)
- Expanded Disability Status Scale (EDSS) less than 7.0
You will not qualify if you...
- Acute MS relapse or intravenous corticosteroid or immunoadsorption treatment within the past six weeks
- Any other medical condition impairing ability to understand or complete the study, such as psychiatric illness or dementia, as decided by the investigator
- Diagnosis of primary or secondary progressive MS
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Heinrich-Heine University, Duesseldorf
Düsseldorf, Germany
Actively Recruiting
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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