The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Brussels, Belgien, 1200
- Université Catholique de Louvain
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Kontakt:
- Vincent Van Pesch, MD, PhD
- Telefonnummer: 003227641082
- E-mail: vincent.vanpesch@saintluc.uclouvain.be
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Ledende efterforsker:
- Vincent Van Pesch, MD, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients with MS and healthy controls
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Characterization of the phenotype of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
Tidsramme: Throughout the entire study, approximately during 40 months
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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
Tidsramme: Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.
Tidsramme: Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
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Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics
Tidsramme: Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FCRL5-PBMC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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