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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brussels, Bélgica, 1200
- Université Catholique de Louvain
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Contacto:
- Vincent Van Pesch, MD, PhD
- Número de teléfono: 003227641082
- Correo electrónico: vincent.vanpesch@saintluc.uclouvain.be
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Investigador principal:
- Vincent Van Pesch, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with MS and healthy controls
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Characterization of the phenotype of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
Periodo de tiempo: 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
Periodo de tiempo: Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.
Periodo de tiempo: 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
Periodo de tiempo: Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FCRL5-PBMC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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