Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis

Recruiting now

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06461481

Run by

Heinrich-Heine University, Duesseldorf

People needed

150

Starts

2024-06-15

Expected to finish

2026-12-31

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed RRMS according to 2017 revised McDonald criteria 12
• De-escalation of high-efficacy treatment or discontinuation of lower efficacy disease modifying therapy (DMT)
• Own a smartphone (only core centre) EDSS <7.0
• able to handle a smartphone (only core centre)

You may not qualify if…

• Patients with an acute MS relapse and/or a history of intravenous corticosteroid treatment or immunoadsorption 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.
• Diagnosis of primary or secondary progressive MS

Where it is running

• Heinrich-Heine University, Duesseldorf — Düsseldorf, Germany (enrolling)

Full record on ClinicalTrials.gov

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