Serum Neurofilament Light in Multiple Sclerosis

NCT ID: NCT06282081

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2027-03-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Serum Neurofilament Light

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG

UNKNOWN

Sponsor Role: collaborator

Monogram Biosciences (LabCorp Specialty Testing Group)

UNKNOWN

Sponsor Role: collaborator

Dent Neuroscience Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dent Neurologic Institute

Amherst, New York, United States

Countries

United States

Other Identifiers

ML 45098

Identifier Type: -

Identifier Source: org_study_id