Understanding how B-cell therapies affect immune responses in multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to longitudinally assess the immune cell profiles of patients with relapsing-remitting multiple sclerosis (RRMS) who are receiving anti-CD20 therapies such as ofatumumab, ocrelizumab, ublituximab, and rituximab. By collecting clinical data, including relapse events and neuropsychological parameters, alongside advanced immunological analyses, the study seeks to characterize changes in immune cell populations and their impact on disease progression. Participants will be monitored over a period of 24 months, with data collected every six months to understand the relationship between immune changes and clinical outcomes.

Why it matters

Who can join: the full rules

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's running

• Heinrich-Heine University, Duesseldorf
  Düsseldorf, Germany Recruiting

Study contacts

• Study coordinator: Saskia Räuber, MD
• Email: SaskiaJanina.Raeuber@med.uni-duesseldorf.de
• Phone: +492118117889

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.