Actively Recruiting
Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-09-18
100
Participants Needed
1
Research Sites
374 weeks
Total Duration
On this page
Sponsors
H
Heinrich-Heine University, Duesseldorf
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed relapsing-remitting multiple sclerosis (RRMS) according to 2017 revised McDonald criteria
- Currently treated with or starting B cell modulating therapies as per product guidelines
- Expanded Disability Status Scale (EDSS) score between 0.0 and 7.0
You will not qualify if you...
- 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 impairing ability to understand information or give informed consent
- Receiving immunosuppressive treatment for conditions other than MS or long-term corticosteroids
- Confirmed infection with Human Immunodeficiency Virus or Hepatitis C Virus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Heinrich-Heine University, Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
Research Team
S
Saskia Räuber, MD
CONTACT
A
Alice Willison, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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