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Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
Sponsor: Heinrich-Heine University, Duesseldorf
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.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2021-10-27
Completion Date
2028-12-31
Last Updated
2025-09-18
Healthy Volunteers
Not specified
Conditions
Interventions
Anti-CD20 antibody
Study participants receive an anti-CD20 antibody according to the summary of product characteristics.
Locations (1)
Heinrich-Heine University, Duesseldorf
Düsseldorf, Germany