Understanding how B-cell therapies affect immune responses in multiple sclerosis
Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies
This study is looking at how B-cell therapies for relapsing-remitting multiple sclerosis affect the immune system and how these changes relate to patients' health over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Drugs / interventions | alemtuzumab, methotrexate, cyclophosphamide, ofatumumab, ocrelizumab, ublituximab, rituximab |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT06586177 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with relapsing-remitting multiple sclerosis who are currently receiving or are about to start B-cell modulating therapies.
Not a fit: Patients who have previously been treated with certain immunosuppressive therapies or have other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how B-cell therapies influence immune responses, potentially leading to improved treatment strategies for patients with multiple sclerosis.
How similar studies have performed: While the approach of assessing immune profiles in relation to B-cell therapies is gaining interest, this specific study's comprehensive methodology is relatively novel and not extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Düsseldorf
- Heinrich-Heine University, Duesseldorf — Düsseldorf, Germany (Recruiting)
Study contacts
- Study coordinator: Saskia Räuber, MD
- Email: SaskiaJanina.Raeuber@med.uni-duesseldorf.de
- Phone: +492118117889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.