The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
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.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习地点
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-
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Brussels、比利时、1200
- Université Catholique de Louvain
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接触：
- Vincent Van Pesch, MD, PhD
- 电话号码：003227641082
- 邮箱：vincent.vanpesch@saintluc.uclouvain.be
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首席研究员：
- Vincent Van Pesch, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with MS and healthy controls
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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A group of patients with MS
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A blood test every 6 months for MS patients : Day1, Month 6, Month 12 and Month 24 |
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A group of healthy volunteers
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A single blood draw for the healthy volunteer |
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A group of volunteers with Sjögren's syndrome
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A single blood draw for the group of volunteers with Sjögren's syndrome |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Characterization of the phenotype of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
大体时间：Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
|
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Characterization of the activity of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS
大体时间：Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.
大体时间：Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
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Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics
大体时间：Throughout the entire study, approximately during 40 months
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Throughout the entire study, approximately during 40 months
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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FCRL5-PBMC
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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