Multiple Sclerosis
Conditions
Brief 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.
Interventions
OTHERA blood test every 6 months for MS patients.
A blood test every 6 months for MS patients : Day1, Month 6, Month 12 and Month 24
OTHERA single blood draw for the healthy volunteer
A single blood draw for the healthy volunteer
OTHERA single blood draw for the group of volunteers with Sjögren's syndrome
A single blood draw for the group of volunteers with Sjögren's syndrome
Sponsors
Université Catholique de Louvain
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of the phenotype of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS | Throughout the entire study, approximately during 40 months |
| Characterization of the activity of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS | Throughout the entire study, approximately during 40 months |
Secondary
| Measure | Time frame |
|---|---|
| Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS. | Throughout the entire study, approximately during 40 months |
| Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics | Throughout the entire study, approximately during 40 months |
Countries
Belgium
Outcome results
None listed