Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
Recruiting · NCT06586177 · 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
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.
Who can take part
Inclusion criteria
- Diagnosed relapsing-remitting multiple sclerosis (RRMS) according to 2017 revised McDonald criteria
- Current treatment with B cell modulating therapies or initiation/transition to B cell modulating therapies according to the "Summary of Product Characteristics (SmPC)"
- EDSS score of 0.0 to 7.0
Exclusion criteria
- Previous treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation or bone marrow transplantation
- Medical, psychiatric, cognitive, or other conditions that, in the opinion of the investigator, impair the patient's ability to understand the patient information and give informed consent
- Patients receiving immunosuppressive treatment for conditions other than MS or long-term corticosteroid treatment
- Patients with confirmed infection by the Human Immunodeficiency Virus or Hepatitis C Virus
Where it is running
1 location listed.
- Heinrich-Heine University, Duesseldorf - Düsseldorf, Germany