The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversité Catholique de Louvain

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with MS and healthy controls

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • A blood test every 6 months for MS patients.

    Other intervention

    A blood test every 6 months for MS patients : Day1, Month 6, Month 12 and Month 24

  • A single blood draw for the healthy volunteer

    Other intervention

    A single blood draw for the healthy volunteer

  • A single blood draw for the group of volunteers with Sjögren's syndrome

    Other intervention

    A single blood draw for the group of volunteers with Sjögren's syndrome

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: A group of patients with MS1 intervention
Group B: A group of healthy volunteers1 intervention
Group C: A group of volunteers with Sjögren's syndrome1 intervention

Trial outcomes

Primary outcomes

1

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
2

Characterization of the activity of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS

Time frame
Throughout the entire study, approximately during 40 months

Secondary outcomes

1

Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.

Time frame
Throughout the entire study, approximately during 40 months
2

Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics

Time frame
Throughout the entire study, approximately during 40 months

Other outcomes

Sponsors and contacts

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