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治療中の再発寛解型多発性硬化症における持続的な臨床下病態活動を検出するための血漿NfLの月次モニタリング (MoMo-NfL)

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

治療中のRRMSにおける持続的臨床下病態活動を検出するための血漿NfLの月次モニタリング

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

84

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • フランス
      • Montpellier、フランス、34295
        • 募集
        • CHU de Montpellier - Hôpital Guy de Chauliac
        • コンタクト：
      • Nantes、フランス、44000
        • まだ募集していません
        • CHU de Nantes
        • コンタクト：
      • Nice、フランス
      • Nîmes、フランス
        • 募集
        • CHU de Nîmes
        • コンタクト：
      • Paris、フランス、75013
        • 募集
        • AP-HP, Hôpital de la Pitié Salpêtrière
        • コンタクト：
      • Rennes、フランス
        • まだ募集していません
        • CHU de Rennes
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～55年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：標準ケア
実験的：pNfLモニタリンググループ
他の：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to evidence of disease activity between groups
時間枠：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
時間枠：week 96

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of CELs between groups
時間枠：week 48

percent of active (contrast-enhancing) lesion
week 48
Proportion of CELs between groups
時間枠：week 96

percent of active (contrast-enhancing) lesion
week 96
Rate of clinical relapses between groups
時間枠：week 48

percentage patients experiencing relapse
week 48
Rate of clinical relapses between groups
時間枠：week 96

percentage patients experiencing relapse
week 96
Time to switch to high efficacy treatments
時間枠：week 48

Days
week 48
Time to switch to high efficacy treatments
時間枠：week 96

Days
week 96
Proportion of patients switching to high efficacy treatments between groups
時間枠：week 48

Percentage
week 48
Proportion of patients switching to high efficacy treatments between groups
時間枠：week 96

Percentage
week 96
Change in pNfL levels in patients experiencing relapse with active MRI in experimental group
時間枠：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
時間枠：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
時間枠：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
時間枠：Upon evidence of disease activity (maximum week 96)

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

その他の成果指標

結果測定
メジャーの説明
時間枠
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
時間枠：week 96

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

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

Brain-Q
week 96
Description of adverse events
時間枠：week 96

Descriptive
week 96
Level of disability
時間枠：Baseline (Day 0)

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

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

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

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

CSCT (Computerized Speed Cognitive Test): score and standard deviation
week 48
Information processing speed impairment
時間枠：week 96

CSCT (Computerized Speed Cognitive Test): score and standard deviation
week 96
Manual dexterity
時間枠：Baseline (Day 0)

NHPT (Nine Hole Peg Test): time (seconds)
Baseline (Day 0)
Manual dexterity
時間枠：week 48

NHPT (Nine Hole Peg Test): time (seconds)
week 48
Manual dexterity
時間枠：week 96

NHPT (Nine Hole Peg Test): time (seconds)
week 96
Walking function
時間枠：Baseline (Day 0)

T25FW (Timed 25-Foot Walk); time (seconds)
Baseline (Day 0)
Walking function
時間枠：week 48

T25FW (Timed 25-Foot Walk); time (seconds)
week 48
Walking function
時間枠：week 96

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

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

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

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

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

EQ-5D-5L score (0-100)
week 48
Patient-reported quality of life
時間枠：week 96

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Centre Hospitalier Universitaire de Nīmes

捜査官

  • 主任研究者：Eric Thouvenot、Centre Hospitalier Universitaire de Nīmes

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年12月12日

一次修了 (推定)

2030年12月1日

研究の完了 (推定)

2030年12月1日

試験登録日

最初に提出

2025年12月5日

QC基準を満たした最初の提出物

2025年12月5日

最初の投稿 (実際)

2025年12月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FINEX/2025/ET-01

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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