Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis
Recruiting · NCT06461481 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heinrich-Heine University, Duesseldorf
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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)
Exclusion criteria
- 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
1 location listed.
- Heinrich-Heine University, Duesseldorf - Düsseldorf, Germany