Clinical trial NCT06282081: Serum Neurofilament Light in Multiple Sclerosis
Official title: Serum Neurofilament Light As a Clinical Tool in Relapsing Remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Lead sponsor: Dent Neuroscience Research Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG
name: Monogram Biosciences (LabCorp Specialty Testing Group)
First posted: 2024-02-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with relapsing remitting multiple sclerosis.

Brief summary: This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with RRMS
2. Adults aged 18+ at time of screening
3. Patients who are able to consent
4. Patients who agree to be reasonably compliant with study protocol for the duration of the study
5. Any subject who is currently being treated with an MS DMT or any subject initiating a new MS DMT throughout the duration of their participation in the study will be initiated and/or treated according to local label

Exclusion Criteria:

1. Patients with current diagnosis of a neurodegenerative or autoimmune disease other than MS that may impact sNfL levels, in the opinion of the investigator (including but not limited to: Alzheimer's disease, Huntington's disease, Amyotrophic Lateral Sclerosis, or Parkinson's disease, systemic lupus erythematosus, rheumatoid arthritis)
2. Inability to complete blood draws
3. Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study
4. Patients who have taken an investigational medication within five half-lives prior to screening or who plan to take an investigational medication during the study
5. Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator

Primary outcomes:
measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received
timeFrame: 1 year
measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice
timeFrame: 1 year
measure: Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements.
timeFrame: 1 year
measure: Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements.
timeFrame: 1 year
measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.
timeFrame: 1 year
measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.
timeFrame: 1 year
Secondary outcomes:
measure: Describe patient demographics
timeFrame: 1 year
measure: Describe patient comorbidities
timeFrame: 1 year
measure: Describe patient concomitant medications
timeFrame: 1 year
measure: Describe patient MS medications
timeFrame: 1 year
measure: Describe patient reasons for MS medication changes
timeFrame: 1 year
measure: Describe patient MS relapses including date of relapse
timeFrame: 1 year
measure: Describe patient MS relapses including clinical findings
timeFrame: 1 year
measure: Describe patient MS relapses including radiologic findings
timeFrame: 1 year
measure: Describe patient MS relapses including severity
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire.
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
timeFrame: 1 year
measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
timeFrame: 1 year
measure: Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available.
timeFrame: 1 year
measure: Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available.
timeFrame: 1 year
measure: Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not.
timeFrame: 1 year
measure: Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
timeFrame: 1 year
measure: Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
timeFrame: 1 year
measure: Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
timeFrame: 1 year
measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
timeFrame: 1 year
measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
timeFrame: 1 year
measure: Describe changes in sNfL levels with magnetic resonance imaging disease activity where available.
timeFrame: 1 year
measure: Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
timeFrame: 1 year
measure: Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
timeFrame: 1 year
measure: Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
timeFrame: 1 year
measure: Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
timeFrame: 1 year
measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
timeFrame: 1 year
measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
timeFrame: 1 year
measure: Compare changes in sNfL levels with magnetic resonance imaging disease activity where available.
timeFrame: 1 year
measure: Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
timeFrame: 1 year
measure: Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
timeFrame: 1 year
measure: Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
timeFrame: 1 year
measure: Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
timeFrame: 1 year
measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
timeFrame: 1 year
measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
timeFrame: 1 year
measure: Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available.
timeFrame: 1 year
measure: Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
timeFrame: 1 year
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
Study officials:
References: