Relapsing Forms of MS
Conditions
Keywords
Clinically isolated syndrome, Multiple Sclerosis, Relapsing forms of Multiple Sclerosis, Active secondary progressive disease
Brief summary
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 \[SAEs\]).
Interventions
As described in the arm.
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants on Treatment with DRF at 1 Year | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline up to 2 years | 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 |
| Change in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire | Baseline up to 2 years | 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. |
| Change in Disability, as Measured by Patient Determined Disease Steps (PDDS) | Baseline up to 2 years | The PDDS has nine ordinal levels ranging between 0 (normal) and 8 (bedridden). Higher scores indicate greater disability. |
| Change in Work Productivity and Activity Impairment Due to Multiple Sclerosis (WPAI- MS) Scores from Baseline | Baseline up to 2 years | 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. |
| Percentage of Participants on Treatment with DRF at 3 Months | 3 months | — |
| Number of Participants with AEs Leading to Treatment Discontinuation | Up to 32 months | 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. |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 32 months | 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. |
| Number of Participants categorized by the types of actions taken to mitigate GI AEs | Up to 32 months | 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. |
| 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 | — |
| Number of Participants with Gastrointestinal (GI) Adverse Events (AEs) | Up to 32 months | 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. |
Countries
United States
Outcome results
None listed