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Maandelijkse monitoring van plasma NfL bij behandelde relapsing-remitting multiple sclerose om aanhoudende infraklinische ziekteactiviteit te detecteren (MoMo-NfL)

2 november 2026 bijgewerkt door: Centre Hospitalier Universitaire de Nīmes

Maandelijks monitoren van plasma NfL bij behandelde RRMS om aanhoudende infraklinische ziekteactiviteit te detecteren

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

84

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
      • Montpellier, Frankrijk, 34295
        • Werving
        • CHU de Montpellier - Hôpital Guy de Chauliac
        • Contact:
      • Nantes, Frankrijk, 44000
        • Nog niet aan het werven
        • CHU de Nantes
        • Contact:
      • Nice, Frankrijk
      • Nîmes, Frankrijk
        • Werving
        • CHU de Nîmes
        • Contact:
      • Paris, Frankrijk, 75013
        • Werving
        • AP-HP, Hôpital de la Pitié Salpêtrière
        • Contact:
      • Rennes, Frankrijk
        • Nog niet aan het werven
        • CHU de Rennes
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Standaard zorg
Experimenteel: pNfL-monitoringgroep
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to evidence of disease activity between groups
Tijdsspanne: 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
Tijdsspanne: week 96

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of CELs between groups
Tijdsspanne: week 48

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

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

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

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

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

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

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

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

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: week 96

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Onderzoekers

  • Hoofdonderzoeker: Eric Thouvenot, Centre Hospitalier Universitaire de Nīmes

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 december 2025

Primaire voltooiing (Geschat)

1 december 2030

Studie voltooiing (Geschat)

1 december 2030

Studieregistratiedata

Eerst ingediend

5 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

5 december 2025

Eerst geplaatst (Werkelijk)

18 december 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FINEX/2025/ET-01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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