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Not yet recruitingNCT07788573Updated Nov 4, 2026

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

An observational study in Multiple Sclerosis, sponsored by Université Catholique de Louvain. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Université Catholique de Louvain · Observational

Updated Nov 4, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Multiple Sclerosis

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03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 90 is close to the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 154 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with MS and healthy controls

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 diseases

For participants with Sjögren's syndrome:

  • Men or women
  • Ages 18 to 80

Exclusion criteria

Exclusion Criteria:

  • For MS patients:
  • No recent relapse (during the 3 months prior to study enrollment)
  • Patients treated with (during the 3 months prior to study enrollment)
  • Patients receiving another therapy unrelated to MS
  • Inability to sign the form

For healthy volunteers:

Subjects not receiving immunosuppressive therapy

For subjects with Sjögren's syndrome:

Subjects not receiving immunosuppressive therapy

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

06

What researchers measure

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

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 41004694 ↗
  • 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. PubMed 29320652 ↗
  • 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. PubMed 30768789 ↗
  • 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. PubMed 34088878 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Start date
Aug 2026→Dec 2026
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Start date Aug 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07788573
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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