The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
August 24, 2026 updated by: Université Catholique de Louvain
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS) and the leading non-traumatic cause of neurological disability in young adults.
Historically considered a T-cell-mediated disease, the paradigm for MS has shifted thanks to the efficacy of therapies targeting B cells.
The investigators recently identified FCRL5 as a B-cell-specific biomarker that is significantly elevated in the cerebrospinal fluid (CSF) of patients with relapsing-remitting MS and is independently associated with an increased risk of developing new MRI lesions within two years of diagnosis (ref.
Deltombe et al., PMID: 41004694).
This project aims to further explore FCRL5 as a prognostic biomarker, study the role of FCRL5-expressing B cells in MS pathogenesis and the effects of disease-modifying therapies on these subsets.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Brussels, Belgium, 1200
- Université Catholique de Louvain
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Contact:
- Vincent Van Pesch, MD, PhD
- Phone Number: 003227641082
- Email: vincent.vanpesch@saintluc.uclouvain.be
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Principal Investigator:
- Vincent Van Pesch, MD, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients with MS and healthy controls
Description
Inclusion Criteria:
- For MS patients:
- Male or female
- Between 18 and 80 years of age
- Diagnosed with MS according to the most recent McDonald criteria (2025)
- Patients who are about to start a new MS treatment or switch treatments
For healthy volunteers:
- Men or women
- Ages 18 to 80
- Healthy volunteers with no neurological conditions or autoimmune diseases
For participants with Sjögren's syndrome:
- Men or women
- Ages 18 to 80
Exclusion Criteria:
- For MS patients:
- No recent relapse (during the 3 months prior to study enrollment)
- Patients treated with corticosteroids (during the 3 months prior to study enrollment)
- Patients receiving another immunosuppressive therapy unrelated to MS
- Inability to sign the informed consent form
For healthy volunteers:
Subjects not receiving immunosuppressive therapy
For subjects with Sjögren's syndrome:
Subjects not receiving immunosuppressive therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
A group of patients with MS
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A blood test every 6 months for MS patients : Day1, Month 6, Month 12 and Month 24
|
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A group of healthy volunteers
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A single blood draw for the healthy volunteer
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A group of volunteers with Sjögren's syndrome
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A single blood draw for the group of volunteers with Sjögren's syndrome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Characterization of the phenotype of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
Time Frame: Throughout the entire study, approximately during 40 months
|
Throughout the entire study, approximately during 40 months
|
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Characterization of the activity of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
Time Frame: Throughout the entire study, approximately during 40 months
|
Throughout the entire study, approximately during 40 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.
Time Frame: Throughout the entire study, approximately during 40 months
|
Throughout the entire study, approximately during 40 months
|
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Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics
Time Frame: Throughout the entire study, approximately during 40 months
|
Throughout the entire study, approximately during 40 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reich DS, Lucchinetti CF, Calabresi PA. Multiple Sclerosis. N Engl J Med. 2018 Jan 11;378(2):169-180. doi: 10.1056/NEJMra1401483. No abstract available.
- Deltombe M, Stolting A, Maggi P, van Pesch V. FCRL5, a B-Cell Marker With Novel Diagnostic and Prognostic Value for Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2025 Nov;12(6):e200485. doi: 10.1212/NXI.0000000000200485. Epub 2025 Sep 26.
- Nutma E, Willison H, Martino G, Amor S. Neuroimmunology - the past, present and future. Clin Exp Immunol. 2019 Sep;197(3):278-293. doi: 10.1111/cei.13279. Epub 2019 Mar 11.
- Cree BAC, Arnold DL, Chataway J, Chitnis T, Fox RJ, Pozo Ramajo A, Murphy N, Lassmann H. Secondary Progressive Multiple Sclerosis: New Insights. Neurology. 2021 Aug 24;97(8):378-388. doi: 10.1212/WNL.0000000000012323. Epub 2021 Jun 4.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
August 19, 2026
First Submitted That Met QC Criteria
August 24, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FCRL5-PBMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.