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New treatment option for Multiple Sclerosis (MS) - Relapsing-remitting
Official title Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
ClinicalTrials.gov ID: NCT07292480
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
- Current MET (IFN, GA, TE, fumarates) for less than 24 months.
- Standard MRI follow-up scan performed less than 90 days before inclusion.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nice, France
- Nîmes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nice, France; Nîmes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.