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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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)

Locations
Other Locations
Germany
Heinrich-Heine University, Duesseldorf
RECRUITING
Düsseldorf
Contact Information
Primary
Marc Günter Pawlitzki, PD Dr. med.
MarcGuenter.Pawlitzki@med.uni-duesseldorf.de
+49 02118117887
Time Frame
Start Date: 2024-06-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Core center
In addition to clinical assessment, MRI examinations will be optionally conducted in patients from core center at baseline and in month 12 and 24. Measurement parameters from clinical MRI examinations (lesion load) are also taken into account from the other study centers. In addition to that, patients from core center will undergo an Optical coherence tomography (OCT) measurement.
Extended cohort
Clinical assessment will be conducted in patients from extended cohort at baseline and in month 6, 12, 18 and 24.
Related Therapeutic Areas
Sponsors
Leads: Heinrich-Heine University, Duesseldorf

This content was sourced from clinicaltrials.gov