Multiple Sclerosis (MS) - Relapsing-remittingMoMo-NfLNCT07292480
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
A study testing Monthly pNfL monitoring in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- Monthly pNfL monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 6 sitesFrance
- Study dates
- 12 Dec 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU de Montpellier - Hôpital Guy de Chauliac
Montpellier, 34295
Xavier AYRIGNAC, PU-PH, 33+ 04 67 33 67 33, x-ayrignac@chu-montpellier.fr
- Not yet recruiting
CHU de Nantes
Nantes, 44000
David LAPLAUD, PU-PH, 33+02 40 08 33 33, david.laplaud@chu-nantes.fr
- Recruiting
CHU de Nice
Nice
Christine LEBRUN FRENAY, Pr., lebrun-frenay.c@chu-nice.fr
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
- Recruiting
AP-HP, Hôpital de la Pitié Salpêtrière
Paris, 75013
Elisabeth MAILLART, PU-PH, 33+ 01 42 17 60 60, elisabeth.maillart@aphp.fr
- Not yet recruiting
CHU de Rennes
Rennes
Laure MICHEL, PU-PH, 33 + 02 99 28 43 21, laure.michel@chu-rennes.fr
About this study
Official title: Monthly Monitoring of Plasma NfL in Treated RRMS to Detect Persistent Infraclinical Disease Activity
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.
Read more
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.
- Being tested
- Monthly pNfL monitoring
- Keywords
- Biomarker
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly pNfL monitoringOther
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
| Study group | Role | What they receive |
|---|---|---|
| pNfL monitoring group | Experimental | Not described Receives: Other: Monthly pNfL monitoring |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to evidence of disease activity between groups
As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
Measured: week 48
Time to evidence of disease activity between groups
As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
Measured: week 96
Secondary outcomes (12)
Proportion of CELs between groups
percent of active (contrast-enhancing) lesion
Measured: week 48
Proportion of CELs between groups
percent of active (contrast-enhancing) lesion
Measured: week 96
Rate of clinical relapses between groups
percentage patients experiencing relapse
Measured: week 48
Rate of clinical relapses between groups
percentage patients experiencing relapse
Measured: week 96
Time to switch to high efficacy treatments
Days
Measured: week 48
Time to switch to high efficacy treatments
Days
Measured: week 96
Proportion of patients switching to high efficacy treatments between groups
Percentage
Measured: week 48
Proportion of patients switching to high efficacy treatments between groups
Percentage
Measured: week 96
Change in pNfL levels in patients experiencing relapse with active MRI in experimental group
pg/mL; measured using Lumipulse® G NfL Blood
Measured: Upon experiencing relapse (maximum week 96)
Change in pNfL levels in patients experiencing acute clinical event in experimental group
pg/mL; measured using Lumipulse® G NfL Blood
Measured: 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
pg/mL; measured using Lumipulse® G NfL Blood
Measured: Upon experiencing radiological disease activity (maximum week 96)
Change in pNfL levels in patients switching to high efficacy treatments
pg/mL; measured using Lumipulse® G NfL Blood
Measured: Upon evidence of disease activity (maximum week 96)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start12 Dec 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Thouvenot, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292480
- Sponsor's protocol ID
- FINEX/2025/ET-01
- Acronym
- MoMo-NfL
- Status last verified
- Nov 2026
- First submitted
- 5 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monthly Monitoring of Plasma NfL in Treated RRMS to Detect Persistent Infraclinical Disease Activity
- ClinicalTrials.gov ID
- NCT07292480
- Acronym / sponsor ID
- MoMo-NfL / FINEX/2025/ET-01
- Keywords
- Biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pNfL monitoring group | Experimental | Other: Monthly pNfL monitoring |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly pNfL monitoringMonthly 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 | Other | pNfL monitoring group |
Primary outcome
Time to evidence of disease activity between groups
Time frame: week 48
As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
Time to evidence of disease activity between groups
Time frame: week 96
As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
12 secondary outcomes
Proportion of CELs between groups
Time frame: week 48
Proportion of CELs between groups
Time frame: week 96
Rate of clinical relapses between groups
Time frame: week 48
Rate of clinical relapses between groups
Time frame: week 96
Time to switch to high efficacy treatments
Time frame: week 48
Time to switch to high efficacy treatments
Time frame: week 96
Proportion of patients switching to high efficacy treatments between groups
Time frame: week 48
Proportion of patients switching to high efficacy treatments between groups
Time frame: week 96
Change in pNfL levels in patients experiencing relapse with active MRI in experimental group
Time frame: Upon experiencing relapse (maximum week 96)
Change in pNfL levels in patients experiencing acute clinical event in experimental group
Time frame: 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
Time frame: Upon experiencing radiological disease activity (maximum week 96)
Change in pNfL levels in patients switching to high efficacy treatments
Time frame: Upon evidence of disease activity (maximum week 96)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Thouvenot principal investigator
Centre Hospitalier Universitaire de Nīmes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly pNfL monitoring in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Thouvenot (04 66 68 32 61, eric.thouvenot@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to evidence of disease activity between groups (time frame: week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.