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

NCT07788573 | Not Yet Recruiting

• 1 other identifier: FCRL5-PBMC
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (3)

A group of patients with MS

Other: A blood test every 6 months for MS patients.

A group of healthy volunteers

Other: A single blood draw for the healthy volunteer

A group of volunteers with Sjögren's syndrome

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

Interventions

A blood test every 6 months for MS patients. OTHER

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

A group of patients with MS

A single blood draw for the healthy volunteer OTHER

A single blood draw for the healthy volunteer

A group of healthy volunteers

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

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

A group of volunteers with Sjögren's syndrome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MS and healthy controls

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Université Catholique de Louvain

Brussels, 1200, Belgium

Location

Related Publications (4)

• 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.

  PMID: 41004694 BACKGROUND

• 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.

  PMID: 29320652 BACKGROUND

• 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.

  PMID: 30768789 BACKGROUND

• 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.

  PMID: 34088878 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)