RecruitingNCT06586177

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

Sponsor

Heinrich-Heine University, Duesseldorf

Enrollment

100 participants

Start Date

Oct 27, 2021

Study Type

OBSERVATIONAL

Conditions

Relapsing Remitting Multiple Sclerosis

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following people with relapsing-remitting multiple sclerosis (RRMS) who are on B-cell modulating therapies — a class of MS drugs that reduce immune activity — to understand the "durable effect" of these treatments, meaning how long their benefits last after stopping the medication. **You may be eligible if...** - You have been diagnosed with relapsing-remitting MS (RRMS) based on 2017 diagnostic criteria - You are currently on a B-cell modulating therapy, or you are starting or switching to one per your neurologist's recommendation - Your disability score (EDSS) is between 0.0 and 7.0 **You may NOT be eligible if...** - You have previously been treated with alemtuzumab, cladribine, cyclophosphamide, or stem cell transplantation - You have a progressive form of MS (not relapsing-remitting) - Your disability level exceeds EDSS 7.0 - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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