Serum Neurofilament Light in Multiple Sclerosis

NCT06282081 | Active Not Recruiting

• 1 other identifier: ML 45098
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  1 year

• 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

  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.

  1 year

• Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements.

  1 year

• Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements.

  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.

  1 year

• Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.

  After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "Knowledge of sNfL level has the potential to be useful in my clinical practice for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely."

  1 year

• Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.

  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."

  1 year

Secondary Outcomes (41)

• Describe patient demographics

  1 year

• Describe patient comorbidities

  1 year

• Describe patient concomitant medications

  1 year

• Describe patient MS medications

  1 year

• Describe patient reasons for MS medication changes

  1 year

Interventions

Serum Neurofilament Light DIAGNOSTIC_TEST

The purpose of this research is to investigate a biomarker, called serum neurofilament light (sNfL), which is measured in blood. This study will attempt to investigate whether or not sNfL is a useful tool for clinicians in patients diagnosed with relapsing remitting multiple sclerosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with relapsing remitting multiple sclerosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dent Neuroscience Research Center: lead
• Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG: collaborator
• Monogram Biosciences (LabCorp Specialty Testing Group): collaborator

Study Sites (1)

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 28, 2024
• Study Start: April 9, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)