이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

치료 중인 재발 완화형 다발성 경화증에서 지속적인 임상 전 질병 활동을 감지하기 위한 혈장 NfL의 월간 모니터링 (MoMo-NfL)

2026년 11월 2일 업데이트: Centre Hospitalier Universitaire de Nīmes

치료 중인 재발 완화형 다발성 경화증(RRMS)에서 지속적인 무증상 질병 활동을 감지하기 위한 혈장 NfL의 월간 모니터링

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

84

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 프랑스
      • Montpellier, 프랑스, 34295
        • 모병
        • CHU de Montpellier - Hôpital Guy de Chauliac
        • 연락하다:
      • Nantes, 프랑스, 44000
        • 아직 모집하지 않음
        • CHU de Nantes
        • 연락하다:
      • Nice, 프랑스
      • Nîmes, 프랑스
        • 모병
        • CHU de Nîmes
        • 연락하다:
      • Paris, 프랑스, 75013
        • 모병
        • AP-HP, Hôpital de la Pitié Salpêtrière
        • 연락하다:
      • Rennes, 프랑스
        • 아직 모집하지 않음
        • CHU de Rennes
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 스탠다드 케어
실험적: pNfL 모니터링 그룹
다른: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time to evidence of disease activity between groups
기간: 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
기간: week 96

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

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of CELs between groups
기간: week 48

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

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

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

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

Days
week 48
Time to switch to high efficacy treatments
기간: week 96

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

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

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

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

기타 결과 측정

결과 측정
측정값 설명
기간
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
기간: week 96

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

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

Brain-Q
week 96
Description of adverse events
기간: week 96

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Centre Hospitalier Universitaire de Nīmes

수사관

  • 수석 연구원: Eric Thouvenot, Centre Hospitalier Universitaire de Nīmes

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 12일

기본 완료 (추정된)

2030년 12월 1일

연구 완료 (추정된)

2030년 12월 1일

연구 등록 날짜

최초 제출

2025년 12월 5일

QC 기준을 충족하는 최초 제출

2025년 12월 5일

처음 게시됨 (실제)

2025년 12월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FINEX/2025/ET-01

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다