Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTSerum 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.
Sponsors
Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG
Monogram Biosciences (LabCorp Specialty Testing Group)
Dent Neuroscience Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. | 1 year | — |
| Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements. | 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. |
| Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe patient reasons for MS medication changes | 1 year | — |
| Describe patient MS relapses including date of relapse | 1 year | — |
| Describe patient MS relapses including clinical findings | 1 year | — |
| Describe patient MS relapses including radiologic findings | 1 year | — |
| Describe patient MS relapses including severity | 1 year | Severity of MS relapses will be described by change in EDSS score from non-relapsing EDSS measurement. |
| 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 | This outcome is based on structured patient questionnaires developed for this study. Patients will answer the following question before and after receiving sNfL results: My current understanding of my MS disease is that I am (circle one): a. Stable, b. Experiencing increased disease activity, c. At risk for relapse, d. Experiencing a relapse, e. Unknown and these answers will be reported. |
| Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. | 1 year | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: How much do you agree with the following statements on a scale of 0 to 10, where 0 is completely disagree and 10 is completely agree? sNfL results were easy to understand: \_\_\_\_\_\_\_ and these results will be reported. |
| 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 | — |
| 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 Expanded Disability Status Scale (EDSS) where available. | 1 year | EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS. |
| Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. | 1 year | SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct. |
| Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. | 1 year | PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression. |
| Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. | 1 year | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. |
| Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. | 1 year | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. |
| Describe changes in sNfL levels with magnetic resonance imaging disease activity where available. | 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 Expanded Disability Status Scale (EDSS) where available. | 1 year | EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS. |
| Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. | 1 year | SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct. |
| Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. | 1 year | PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression. |
| Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. | 1 year | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. |
| Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. | 1 year | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. |
| Compare changes in sNfL levels with magnetic resonance imaging disease activity where available. | 1 year | — |
| Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. | 1 year | — |
| Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. | 1 year | — |
| Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. | 1 year | SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct. |
| Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. | 1 year | PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression. |
| Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. | 1 year | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. |
| Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. | 1 year | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. |
| Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available. | 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 | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: How much do you agree with the following statements on a scale of 0 to 10, where 0 is completely disagree and 10 is completely agree? Compared to MRI, sNfL draws were more accessible: \_\_\_\_\_\_\_\_\_\_\_\_ and these answers will be reported. |
| Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. | 1 year | — |
| Describe patient demographics | 1 year | — |
| Describe patient comorbidities | 1 year | — |
| Describe patient concomitant medications | 1 year | — |
| Describe patient MS medications | 1 year | — |
Countries
United States
Outcome results
None listed