Serum Neurofilament Light As a Clinical Tool in Relapsing Remitting Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Dent Neuroscience Research Center
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with RRMS
- •Adults aged 18+ at time of screening
- •Patients who are able to consent
- •Patients who agree to be reasonably compliant with study protocol for the duration of the study
- •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
- •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)
- •Inability to complete blood draws
- •Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study
- •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
- •Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator
Outcomes
Primary Outcomes
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
Time Frame: 1 year
This outcome is based on structured clinician questionnaires developed for this study. Prior to receiving patient sNfL results, clinicians will answer the question "My current clinical impression of this patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)." After receiving patient sNfL results, clinicians will answer the question "After reviewing this patient's sNfL results along with other diagnostic testing at this time, my opinion of the patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)" and these answers will be reported.
Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements.
Time Frame: 1 year
This outcome is based on a structured clinician questionnaire developed for this study. Prior to receiving patient's sNfL results, clinicians will answer the question, "Is this an unscheduled sNfL measurement? Yes No; If yes, please specify reason why this sNfL measurement was scheduled" and these answers will be reported.
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
Time Frame: 1 year
This outcome is based on a structured clinician questionnaire developed for this study. Clinicians will answer the question: "This patient's sNfL results have had the following impact on my opinions or confidence in this patient's care plan, or have potential to guide my clinical practice in the following way (please list specifics, e.g., increased confidence in assessment of disease status; decision to order additional testing; change in mediation therapy; change in frequency of follow-up, etc)" and these answers will be reported.
Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements.
Time Frame: 1 year
Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.
Time Frame: 1 year
After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "sNfL results has the potential to be a useful/suitable alternative to MRI for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely."
Secondary Outcomes
- Describe patient MS relapses including clinical findings(1 year)
- Describe patient MS relapses including radiologic findings(1 year)
- Compare changes in sNfL levels with magnetic resonance imaging disease activity where available.(1 year)
- Describe patient reasons for MS medication changes(1 year)
- Describe patient concomitant medications(1 year)
- Describe patient MS relapses including severity(1 year)
- Describe patient MS relapses including date of relapse(1 year)
- Describe patient comorbidities(1 year)
- Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.(1 year)
- Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.(1 year)
- Describe patient demographics(1 year)
- Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.(1 year)
- Describe changes in sNfL levels with magnetic resonance imaging disease activity where available.(1 year)
- Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.(1 year)
- Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.(1 year)
- Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.(1 year)
- Describe patient MS medications(1 year)
- Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.(1 year)
- Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.(1 year)
- Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.(1 year)
- Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.(1 year)
- Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.(1 year)
- Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available.(1 year)
- Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.(1 year)
- 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.(1 year)
- 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.(1 year)
- 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.(1 year)
- Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.(1 year)
- Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.(1 year)
- Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not.(1 year)
- Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.(1 year)
- Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.(1 year)
- Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.(1 year)
- Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.(1 year)
- Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.(1 year)
- Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.(1 year)