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对治疗中的复发缓解型多发性硬化症患者进行血浆NfL月度监测以检测持续性亚临床疾病活动 (MoMo-NfL)

2026年11月2日 更新者：Centre Hospitalier Universitaire de Nīmes

对已治疗复发缓解型多发性硬化症患者进行血浆NfL月度监测以检测持续性亚临床疾病活动

Reference MRI scan is recommended 6 months after treatment onset in patients with multiple sclerosis (MS), and follow-up scans at 12 months later to monitor subclinical activity. When monitoring treatment response in patients treated with disease modifying treatments (DMTs), the measurement of new or enlarging T2/FLAIR hyperintense lesions (NELs) is the preferred MRI method supplemented by contrast-enhancing lesions (CELs) for monitoring treatment response. However, some studies have suggested the deposition of gadolinium-based contrast agents in the basal ganglia and dentate nucleus of patients who underwent serial MRI acquisitions. Although significant clinical consequences of these deposits have not been demonstrated, further studies are required to better understand the potential long-term biological and clinical effects of gadolinium administration. To circumvent this potential risk, several recommendations suggested avoiding unnecessary use of gadolinium for follow-up scans. New sequences are also developed to replace gadolinium injection for the detection of active lesions. Moreover, MRI remains costly and time-consuming. In addition, systematic yearly MRI monitoring is not adapted to detect silent active lesions. This can delay identification of treatment failure and increase the risk of relapses and disability worsening, especially in the context of escalation therapy.

Therefore, biological markers could allow more frequent analysis of disease activity and detect treatment failure earlier than classical clinical and MRI monitoring. Their use would greatly help clinicians to switch for high efficacy treatments (HET) and avoid potential relapses.

Measurement of a structural axonal protein, neurofilament, in serum or plasma has shown promise as a marker of neuroaxonal injury and a measure of treatment response. In MS, cerebrospinal fluid (CSF) neurofilament-light chain (NfL) is also increased and is positively associated with MRI lesion load and disability scores and is a marker of treatment response.

WThe study authors hypothesize that monthly plasma neurofilament-light chain (pNfL) monitoring can sensitively highlight subclinical (radiological disease activity) RDA by performing early MRI scans to confirm EDA and lead to timely treatment escalation.

The main objective of this study is to compare the time to EDA in both arms (monthly pNfL monitoring vs. standard care with regular MRI scans), in patients with EDA.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

84

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 法国
      • Montpellier、法国、34295
        • 招聘中
        • CHU de Montpellier - Hôpital Guy de Chauliac
        • 接触：
      • Nantes、法国、44000
      • Nice、法国
      • Nîmes、法国
        • 招聘中
        • CHU de Nîmes
        • 接触：
      • Paris、法国、75013
        • 招聘中
        • AP-HP, Hôpital de la Pitié Salpêtrière
        • 接触：
      • Rennes、法国

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient with RRMS according to 2024 McDonald's criteria.
  • Less than 10 years from disease onset.
  • Active RRMS (EDA) observed during the last 24 months: relapse and/or NELs and/or CELs as compared to a previous MRI performed within 24 months (± 3 months).
  • Current MET (IFN, GA, TE, fumarates) for less than 24 months.
  • Standard MRI follow-up scan performed less than 90 days before inclusion.
  • Clinically stable disease for at least 30 days.
  • Patients included in observational studies and cohorts (OFSEP, PROMISE …) will be eligible for inclusion in MoMo-NfL.
  • For women with reproductive potential: negative pregnancy test at the time of inclusion and use of an effective method to avoid pregnancy for the duration of the trial.
  • Patients able to adhere to the study visit schedule.
  • Patient must have signed and given the consent.
  • Patient affiliated or beneficiary of a health insurance plan.

Exclusion Criteria:

  • Pregnant or breastfeeding woman.
  • Patient unable to perform brain and/or spinal cord MRI scans.
  • Patient not willing to perform monthly blood punctures.
  • Patient treated with HET (S1P agonists, natalizumab, ocrelizumab, ofatumumab, rituximab, alemtuzumab, cladribine, mitoxantrone).
  • Patient with a relapse within 6 months before inclusion.
  • Patient with CELs within 3 months before inclusion.
  • Patient with progressive MS.
  • Patient unable to sign the consent.
  • It is impossible to correctly inform the patient.
  • Patient already participating in therapeutic research or in an exclusion period. The exclusion period corresponds to five half-lives (t1/2) of the experimental drug.
  • Patient under judicial protection, or is an adult under guardianship.
  • Female patients who are pregnant or breastfeeding or of reproductive potential who are not willing to employ effective birth control for the duration of the trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：标准护理
实验性的：pNfL监测组
其他：Monthly pNfL monitoring

Monthly pNfL monitoring from blood samples. In case of >50% pNfL increase as compared to the mean of the 2 previous measures, an unscheduled visit with brain and spinal cord MRI will be scheduled

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to evidence of disease activity between groups
大体时间：week 48

As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
week 48
Time to evidence of disease activity between groups
大体时间：week 96

As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
week 96

次要结果测量

结果测量
措施说明
大体时间
Proportion of CELs between groups
大体时间：week 48

percent of active (contrast-enhancing) lesion
week 48
Proportion of CELs between groups
大体时间：week 96

percent of active (contrast-enhancing) lesion
week 96
Rate of clinical relapses between groups
大体时间：week 48

percentage patients experiencing relapse
week 48
Rate of clinical relapses between groups
大体时间：week 96

percentage patients experiencing relapse
week 96
Time to switch to high efficacy treatments
大体时间：week 48

Days
week 48
Time to switch to high efficacy treatments
大体时间：week 96

Days
week 96
Proportion of patients switching to high efficacy treatments between groups
大体时间：week 48

Percentage
week 48
Proportion of patients switching to high efficacy treatments between groups
大体时间：week 96

Percentage
week 96
Change in pNfL levels in patients experiencing relapse with active MRI in experimental group
大体时间：Upon experiencing relapse (maximum week 96)

pg/mL; measured using Lumipulse® G NfL Blood
Upon experiencing relapse (maximum week 96)
Change in pNfL levels in patients experiencing acute clinical event in experimental group
大体时间：Upon experiencing an acute clinical event (maximum week 96)

pg/mL; measured using Lumipulse® G NfL Blood
Upon experiencing an acute clinical event (maximum week 96)
Change in pNfL levels in patients experiencing radiological disease activity without clinical symptoms in experimental group
大体时间：Upon experiencing radiological disease activity (maximum week 96)

pg/mL; measured using Lumipulse® G NfL Blood
Upon experiencing radiological disease activity (maximum week 96)
Change in pNfL levels in patients switching to high efficacy treatments
大体时间：Upon evidence of disease activity (maximum week 96)

pg/mL; measured using Lumipulse® G NfL Blood
Upon evidence of disease activity (maximum week 96)

其他结果措施

结果测量
措施说明
大体时间
To estimate the best threshold of pNfL increase (last measure as compared to the mean of 2 previous measures) with best accuracy to detect evidence of disease activity
大体时间：week 96

pNfL levels in pg/mL
week 96
Time to evidence of disease activity using optimized threshold in experimental group
大体时间：week 96

Months
week 96
Correlation between basal pNfL fluctuations in patients with no evidence of disease activity and brain health questionnaire score
大体时间：week 96

Brain-Q
week 96
Description of adverse events
大体时间：week 96

Descriptive
week 96
Level of disability
大体时间：Baseline (Day 0)

EDSS (Extanded Disability Status Scale) score, range: 0.0-10
Baseline (Day 0)
Level of disability
大体时间：Week 48

EDSS (Extanded Disability Status Scale) score, range: 0.0-10
Week 48
Level of disability
大体时间：week 96

EDSS (Extanded Disability Status Scale) score, range: 0.0-10
week 96
Information processing speed impairment
大体时间：Baseline (Day 0)

CSCT (Computerized Speed Cognitive Test): score and standard deviation
Baseline (Day 0)
Information processing speed impairment
大体时间：week 48

CSCT (Computerized Speed Cognitive Test): score and standard deviation
week 48
Information processing speed impairment
大体时间：week 96

CSCT (Computerized Speed Cognitive Test): score and standard deviation
week 96
Manual dexterity
大体时间：Baseline (Day 0)

NHPT (Nine Hole Peg Test): time (seconds)
Baseline (Day 0)
Manual dexterity
大体时间：week 48

NHPT (Nine Hole Peg Test): time (seconds)
week 48
Manual dexterity
大体时间：week 96

NHPT (Nine Hole Peg Test): time (seconds)
week 96
Walking function
大体时间：Baseline (Day 0)

T25FW (Timed 25-Foot Walk); time (seconds)
Baseline (Day 0)
Walking function
大体时间：week 48

T25FW (Timed 25-Foot Walk); time (seconds)
week 48
Walking function
大体时间：week 96

T25FW (Timed 25-Foot Walk); time (seconds)
week 96
Patient-reported change in status
大体时间：Baseline (Day 0)

PGIC (Patient Global Impression of Change scale): score (7 points Likert scale)
Baseline (Day 0)
Patient-reported change in status
大体时间：Week 48

PGIC (Patient Global Impression of Change scale): score (7 points Likert scale)
Week 48
Patient-reported change in status
大体时间：week 96

PGIC (Patient Global Impression of Change scale): score (7 points Likert scale)
week 96
Patient-reported quality of life
大体时间：Baseline (Day 0)

EQ-5D-5L score (0-100)
Baseline (Day 0)
Patient-reported quality of life
大体时间：week 48

EQ-5D-5L score (0-100)
week 48
Patient-reported quality of life
大体时间：week 96

EQ-5D-5L score (0-100)
week 96

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Universitaire de Nīmes

调查人员

  • 首席研究员：Eric Thouvenot、Centre Hospitalier Universitaire de Nīmes

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月12日

初级完成 (估计的)

2030年12月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2025年12月5日

首先提交符合 QC 标准的

2025年12月5日

首次发布 (实际的)

2025年12月18日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FINEX/2025/ET-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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