Monthly blood monitoring of neurofilament light to detect hidden activity in treated relapsing-remitting MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with relapsing-remitting MS on disease-modifying therapy will have monthly plasma neurofilament light (pNfL) measurements to monitor for persistent infraclinical disease activity. Results will be compared with routine MRI and clinical findings to identify correlations between pNfL rises and new or enlarging lesions or relapses. The approach seeks to determine whether regular blood monitoring can reliably signal disease activity and potentially reduce reliance on contrast-enhanced MRI. Eligible participants are early in their disease course, clinically stable at entry, and receiving first-line MS therapies for less than 24 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Montpellier - Hôpital Guy de Chauliac
  Montpellier, France Recruiting
• CHU de Nice
  Nice, France Recruiting
• CHU de Nîmes
  Nîmes, France Recruiting
• AP-HP, Hôpital de la Pitié Salpêtrière
  Paris, France Recruiting
• CHU de Nantes
  Nantes, France Not yet recruiting
• CHU de Rennes
  Rennes, France Not yet recruiting

Study contacts

• Principal investigator: Eric Thouvenot — Centre Hospitalier Universitaire de Nīmes
• Study coordinator: Eric Thouvenot
• Email: eric.thouvenot@chu-nimes.fr
• Phone: 04 66 68 32 61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.