The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
- Sponsor
- Université Catholique de Louvain
- Study ID
- NCT07788573
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- A blood test every 6 months for MS patients. — OTHERA blood test every 6 months for MS patients : Day1, Month 6, Month 12 and Month 24
- A single blood draw for the healthy volunteer — OTHERA single blood draw for the healthy volunteer
- A single blood draw for the group of volunteers with Sjögren's syndrome — OTHERA single blood draw for the group of volunteers with Sjögren's syndrome
Study Details
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.
Key Dates
- First listed
- Aug 26, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 90 participants (estimated)
Arms
- Arm: A group of patients with MS
- Arm: A group of healthy volunteers
- Arm: A group of volunteers with Sjögren's syndrome
Primary Outcome Measure
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 ]
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