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

NCT06586177 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-09-18

No results posted yet for this 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.

Conditions

  • Relapsing-remitting Multiple Sclerosis

Interventions

DRUG

Anti-CD20 antibody

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06586177 on ClinicalTrials.gov