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 \[SAEs\]).
Study Type
OBSERVATIONAL
Enrollment
75
As described in the arm.
Regina Berkovich MD Phd Inc
West Hollywood, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Norton Neuroscience Institute
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Glendale Neurological Associates, PC
Farmington, Michigan, United States
Memorial Healthcare
Owosso, Michigan, United States
St. Luke's Neurology
Kansas City, Missouri, United States
CentraState Healthcare System - Linda Cardinale MS Center
Freehold, New Jersey, United States
MS Center at St Barnabas
Livingston, New Jersey, United States
Multiple Sclerosis Center JSUMC
Neptune City, New Jersey, United States
...and 8 more locations
Percentage of Participants on Treatment with DRF at 1 Year
Time frame: 1 year
Percentage of Participants on Treatment with DRF at 3 Months
Time frame: 3 months
Percentage of Participants on Treatment with DRF at 2 Years
Time frame: 2 years
Annualized Relapse Rate (ARR) with DRF
Time frame: At 1 and 2 years
Percentage of Participants Relapsed
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 32 months
Median Absolute Lymphocyte Count (ALC) Over Time
Time frame: Baseline up to 2 years
Percent Change in Median ALC from Baseline
Time frame: 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
Time frame: Up to 32 months
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