NCT06586177 Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
| NCT ID | NCT06586177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Relapsing-remitting Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-10-27 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-10-27 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06586177 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Relapsing-remitting Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06586177 currently recruiting?
Yes, NCT06586177 is actively recruiting participants. Contact the research team at SaskiaJanina.Raeuber@med.uni-duesseldorf.de for enrollment information.
Where is the NCT06586177 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT06586177 clinical trial?
NCT06586177 is sponsored by Heinrich-Heine University, Duesseldorf. The trial plans to enroll 100 participants.
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