Actively Recruiting

Age: 18Years +
All Genders
NCT06461481

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Heinrich-Heine University, Duesseldorf

Düsseldorf, Germany

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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