Multiple SclerosisNCT07788573
The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
An observational study of Multiple Sclerosis, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- A blood test every 6 months for MS patients., A single blood draw for the healthy volunteer and A single blood draw for the group of volunteers with Sjögren's syndrome
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with MS and healthy controls
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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:
Show all 9Show fewer
- Subjects not receiving immunosuppressive therapy
- For subjects with Sjögren's syndrome:
- Subjects not receiving immunosuppressive therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Université Catholique de Louvain
Brussels, 1200
Vincent Van Pesch, MD, PhD, 003227641082, vincent.vanpesch@saintluc.uclouvain.be
Vincent Van Pesch, MD, PhD
About this study
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
- Being tested
- A blood test every 6 months for MS patients., A single blood draw for the healthy volunteer, A single blood draw for the group of volunteers with Sjögren's syndrome
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 single blood draw for the healthy volunteerOther
A single blood draw for the healthy volunteer
A single blood draw for the group of volunteers with Sjögren's syndromeOther
A single blood draw for the group of volunteers with Sjögren's syndrome
| Study group | Role | What they receive |
|---|---|---|
| A group of patients with MS | Not described Receives: Other: A blood test every 6 months for MS patients. | |
| A group of healthy volunteers | Not described Receives: Other: A single blood draw for the healthy volunteer | |
| A group of volunteers with Sjögren's syndrome | Not described Receives: Other: A single blood draw for the group of volunteers with Sjögren's syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the phenotype of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
Measured: Throughout the entire study, approximately during 40 months
Characterization of the activity of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
Measured: Throughout the entire study, approximately during 40 months
Secondary outcomes (2)
Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.
Measured: Throughout the entire study, approximately during 40 months
Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics
Measured: Throughout the entire study, approximately during 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startDec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788573
- Sponsor's protocol ID
- FCRL5-PBMC
- Status last verified
- Nov 2026
- First submitted
- 19 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41004694Reich 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 29320652Nutma 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 30768789Cree 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
- ClinicalTrials.gov ID
- NCT07788573
- Acronym / sponsor ID
- FCRL5-PBMC
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MS and healthy controls
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 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 | Other | A group of patients with MS |
| A single blood draw for the healthy volunteerA single blood draw for the healthy volunteer | Other | A group of healthy volunteers |
| A single blood draw for the group of volunteers with Sjögren's syndromeA single blood draw for the group of volunteers with Sjögren's syndrome | Other | A group of volunteers with Sjögren's syndrome |
Primary outcome
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
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
2 secondary outcomes
Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.
Time frame: Throughout the entire study, approximately during 40 months
Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics
Time frame: Throughout the entire study, approximately during 40 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 41004694Deltombe 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.
- Background: PubMed 29320652Reich 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.
- Background: PubMed 30768789Nutma 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.
- Background: PubMed 34088878Cree 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788573, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.