Study of Diroximel Fumarate in the Real-World Setting

Study Overview
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Brief Summary
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The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs) and to explore the real-world safety profile of DRF (ie, gastrointestinal [GI] tolerability, lymphocyte dynamics, adverse events [AEs] leading to discontinuation, and serious adverse events [SAEs]).

Official Title
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A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-US Study)

Conditions
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Relapsing Forms of MS

Intervention / Treatment
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* Drug: Diroximel Fumarate


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the USPI. DRF prescribed and planned to be initiated within 60 days after enrollment. Key Exclusion Criteria: History of gastric bypass or required use of feeding tubes. Have received prior treatment with DRF. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diroximel Fumarate<br>Participants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled. | Drug: Diroximel Fumarate<br>* As described in the arm.<br>* Other names: BIIB098;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants on Treatment with DRF at 1 Year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants on Treatment with DRF at 3 Months |  | 3 months | 
| Percentage of Participants on Treatment with DRF at 2 Years |  | 2 years | 
| Annualized Relapse Rate (ARR) with DRF |  | At 1 and 2 years | 
| Percentage of Participants Relapsed |  | At 1 and 2 years | 
| Change in Processing Speed Test (PST) Score from Baseline | PST measures mental processing speed. The PST will be assessed using multiple sclerosis performance test (MSPT). The participants will be shown some symbols and corresponding numbers. The participants will be then asked to input the numbers corresponding to the given symbols in empty rows. Higher number of correct responses indicates better cognition | Baseline up to 2 years | 
| Change in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire | Neuro-QOL uses a T score which has a mean of 50 and SD of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured. | Baseline up to 2 years | 
| Change in Disability, as Measured by Patient Determined Disease Steps (PDDS) | The PDDS has nine ordinal levels ranging between 0 (normal) and 8 (bedridden). Higher scores indicate greater disability. | Baseline up to 2 years | 
| Change in Work Productivity and Activity Impairment Due to Multiple Sclerosis (WPAI- MS) Scores from Baseline | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Higher numbers indicate greater impairment and less productivity. | Baseline up to 2 years | 
| Number of Participants with Gastrointestinal (GI) Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to 32 months | 
| Number of Participants with AEs Leading to Treatment Discontinuation | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to 32 months | 
| Number of Participants with Serious Adverse Events (SAEs) | An SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event. | Up to 32 months | 
| Number of Participants categorized by the types of actions taken to mitigate GI AEs | The actions taken will include temporary dose reduction, temporary dose interruption, initiation of concomitant GI medication, taking DRF dose with food, permanent discontinuation, or other action. | Up to 32 months | 
| Median Absolute Lymphocyte Count (ALC) Over Time |  | Baseline up to 2 years | 
| Percent Change in Median ALC from Baseline |  | Baseline up to 2 years | 
| Number of Participants with Lymphopenia According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE)Severity Grading |  | Up to 32 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinically isolated syndrome, Multiple Sclerosis, Relapsing forms of Multiple Sclerosis, Active secondary progressive disease