Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies

Condition(s) studied

Investigational drug(s) / intervention(s)

Anti-CD20 antibody: Study participants receive an anti-CD20 antibody according to the summary of product characteristics.

Study summary

This prospective, observational clinical study aims to longitudinally assess peripheral immune cell profiles of patients with relapsing-remitting multiple sclerosis (RRMS) receiving anti-CD20 therapy with ofatumumab (OFA), ocrelizumab (OCR), ublituximab (UBX), and rituximab (RTX). Throughout the study, clinical data - including relapse events, patient scores, and neuropsychological parameters - will be collected, along with results from imaging techniques such as Optical Coherence Tomography (OCT) and Magnetic Resonance Imaging (MRI). This clinical data will be combined with immunological analyses, including multidimensional flow cytometry (mFC), bulk RNA sequencing (bulk-Seq), T and B cell receptor sequencing (TCR/BCR-Seq), proteomics, and immunoglobulin analysis. This approach aims to enable a detailed characterization of changes in the immune cell repertoire and their impact on the clinical disease course.

Eligibility

Primary outcome measure(s)

• Change from baseline in the peripheral immune cell profile — Baseline up to 48 months
  Immune cell subpopulations will be analyzed longitudinally by multidimensional flow cytometry \[% of all living cells and mean fluorescent intensity of different cell surface markers\].
• Change from baseline in protein profile of the peripheral blood — Baseline up to 48 months
  Protein expression will be measured longitudinally using proteomics.
• Change from baseline in TCR/BCR profile — Baseline up to 48 months
  T cell and B cell receptor profile will be measured longitudinally using BCR- and TCR-sequencing.

Trial sites (1)

More Heinrich-Heine University, Duesseldorf trials in Germany

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