Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach

Condition(s) studied

Study summary

This observational study wants to examine the disease progression independent of relapses in patients with Multiple Sclerosis (MS) that are treated with monoclonal antibodies. Participants will be clinically examined every 6 months and optionally receive a magnetic resonance imaging (MRI) every 12 months. The investigators will also take blood for blood biomarker tests with each clinical examination. Optionally, digital data can be continuously collected via smartphone and smartwatch.

With this information the study will compare the results from clinical, digital, radiological, and blood-based tests with the disease progression the participants report themselves. This study aims to investigate what percentage auf patients with MS under antibody treatment experience a slow progression of the disease.

Eligibility

Primary outcome measure(s)

• Percentage of Progression independent from relapse (PIRA )at month 24 — Baseline up to 24 months
  Composite confirmed disability accumulation (CDA) defined as disability increase from study baseline, measured by Expanded Disability Status Scale (EDSS) (an increase of ≥1.0 points if baseline EDSS was ≤5.5 points or an ≥0.5-point increase if baseline EDSS)was \>5.5 points) or an increase of 20% of more in Timed 25-Foot Walk (T25FW) or an increase of 20% or more in Nine-Hole Peg Test (9HPT) confirmed at the subsequent study visit (minimum acceptable interval 12 weeks). Composite relapse-associated worsening (RAW) events are defined as a subset of composite CDA events. In these, the initial disability increase from study baseline occurred 90 or fewer days after the onset of a relapse

Trial sites (1)

More Heinrich-Heine University, Duesseldorf trials in Germany

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