Monthly pNfL monitoring
OtherMonthly 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
NCT Number: NCT07292480
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Not applicable
CHU de Nice, Nice, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: week 48
As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
Time frame: week 96
As assessed by new relapse and/or occurrence of NELs and/or CELs on a follow-up MRI scan
Time frame: week 48
percent of active (contrast-enhancing) lesion
Time frame: week 96
percent of active (contrast-enhancing) lesion
Time frame: week 48
percentage patients experiencing relapse
Time frame: week 96
percentage patients experiencing relapse
Time frame: week 48
Days
Time frame: week 96
Days
Time frame: week 48
Percentage
Time frame: week 96
Percentage
Time frame: Upon experiencing relapse (maximum week 96)
pg/mL; measured using Lumipulse® G NfL Blood
Time frame: Upon experiencing an acute clinical event (maximum week 96)
pg/mL; measured using Lumipulse® G NfL Blood
Time frame: Upon experiencing radiological disease activity (maximum week 96)
pg/mL; measured using Lumipulse® G NfL Blood
Time frame: Upon evidence of disease activity (maximum week 96)
pg/mL; measured using Lumipulse® G NfL Blood
Time frame: week 96
pNfL levels in pg/mL
Time frame: week 96
Months
Time frame: week 96
Brain-Q
Time frame: week 96
Descriptive
Time frame: Baseline (Day 0)
EDSS (Extanded Disability Status Scale) score, range: 0.0-10
Time frame: Week 48
EDSS (Extanded Disability Status Scale) score, range: 0.0-10
Time frame: week 96
EDSS (Extanded Disability Status Scale) score, range: 0.0-10
Time frame: Baseline (Day 0)
CSCT (Computerized Speed Cognitive Test): score and standard deviation
Time frame: week 48
CSCT (Computerized Speed Cognitive Test): score and standard deviation
Time frame: week 96
CSCT (Computerized Speed Cognitive Test): score and standard deviation
Time frame: Baseline (Day 0)
NHPT (Nine Hole Peg Test): time (seconds)
Time frame: week 48
NHPT (Nine Hole Peg Test): time (seconds)
Time frame: week 96
NHPT (Nine Hole Peg Test): time (seconds)
Time frame: Baseline (Day 0)
T25FW (Timed 25-Foot Walk); time (seconds)
Time frame: week 48
T25FW (Timed 25-Foot Walk); time (seconds)
Time frame: week 96
T25FW (Timed 25-Foot Walk); time (seconds)
Time frame: Baseline (Day 0)
PGIC (Patient Global Impression of Change scale): score (7 points Likert scale)
Time frame: Week 48
PGIC (Patient Global Impression of Change scale): score (7 points Likert scale)
Time frame: week 96
PGIC (Patient Global Impression of Change scale): score (7 points Likert scale)
Time frame: Baseline (Day 0)
EQ-5D-5L score (0-100)
Time frame: week 48
EQ-5D-5L score (0-100)
Time frame: week 96
EQ-5D-5L score (0-100)
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nīmes
Other
Monthly Monitoring of Plasma NfL in Treated RRMS to Detect Persistent Infraclinical Disease Activity
Acronym: MoMo-NfL
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