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NCT07788573
The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
Conditions: Multiple Sclerosis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Enrollment: 90
Sponsor: Université Catholique de Louvain
Location: Université Catholique de Louvain Brussels
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07788573). StuddyBuddy aggregates publicly available trial information.