Clinical Trial

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

Study acronym: SAFEGUIDE-MS
Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-10; most recent amendment 2024-07-01.
Trial Details
NCT Number NCT06461481
Lead Sponsor Heinrich-Heine University, Duesseldorf
Conditions Multiple Sclerosis
Enrollment 150 participants
Start Date 2024-06-15
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-03