Status:
RECRUITING
Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
Novartis
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-60 years
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 ...
Detailed Description
B cell targeted therapies have become a key element in the treatment of multiple sclerosis due to their effectiveness in rapid and long-lasting depletion of B cells in peripheral blood (PB), significa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06586177
Start Date
October 27 2021
End Date
December 31 2028
Last Update
September 18 2025
Active Locations (1)
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1
Heinrich-Heine University, Duesseldorf
Düsseldorf, Germany, 40225