Monthly blood monitoring of neurofilament light to detect hidden activity in treated relapsing-remitting MS
Monthly Monitoring of Plasma NfL in Treated RRMS to Detect Persistent Infraclinical Disease Activity
This will test whether monthly blood measurements of neurofilament light (pNfL) can find hidden disease activity in people with treated relapsing-remitting MS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | natalizumab, ocrelizumab, ofatumumab, rituximab, alemtuzumab |
| Locations | 2 sites (Nice and 1 other locations) |
| Trial ID | NCT07292480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People with relapsing-remitting MS within 10 years of onset who have had active disease in the past 24 months, are clinically stable for at least 30 days, have a recent MRI, and have been on specified first-line DMTs for less than 24 months.
Not a fit: Patients with progressive MS, disease onset more than 10 years ago, those not on the specified therapies, pregnant or breastfeeding women, or those unable to attend monthly visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could allow earlier detection of ongoing nerve injury and reduce the need for repeated gadolinium-enhanced MRIs.
How similar studies have performed: Previous research has shown that NfL levels in blood correlate with MS disease activity and treatment response, but using monthly pNfL as a routine replacement for contrast MRI is a newer, not yet established approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with RRMS according to 2017 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). * 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 this trial is running
Nice and 1 other locations
- CHU de Nice — Nice, France (Recruiting)
- CHU de Nîmes — Nîmes, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.