Study of Diroximel Fumarate in the Real-World Setting
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ClinicalTrials.gov Identifier: NCT04746976 |
Recruitment Status :
Recruiting
First Posted : February 10, 2021
Last Update Posted : May 10, 2022
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Condition or disease | Intervention/treatment |
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Relapsing Forms of MS | Drug: Diroximel Fumarate |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-US Study) |
Actual Study Start Date : | March 1, 2021 |
Estimated Primary Completion Date : | September 1, 2024 |
Estimated Study Completion Date : | September 1, 2024 |

Group/Cohort | Intervention/treatment |
---|---|
Diroximel Fumarate
Participants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled.
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Drug: Diroximel Fumarate
As described in the arm.
Other Names:
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- 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
- Number of Participants with Gastrointestinal (GI) Adverse Events (AEs) [ Time Frame: 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 AEs Leading to Treatment Discontinuation [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04746976
Contact: US Biogen Clinical Trial Center | 866-633-4636 | clinicaltrials@biogen.com | |
Contact: Global Biogen Clinical Trial Center | clinicaltrials@biogen.com |
United States, District of Columbia | |
Research Site | Enrolling by invitation |
Washington, District of Columbia, United States, 20007 | |
United States, Massachusetts | |
Research Site | Recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Research Site | Recruiting |
Farmington, Michigan, United States, 48071 | |
Research Site | Recruiting |
Owosso, Michigan, United States, 48867 | |
United States, New Jersey | |
Research Site | Recruiting |
Neptune, New Jersey, United States, 07753 | |
Research Site | Active, not recruiting |
West Orange, New Jersey, United States, 07052 | |
United States, New York | |
Research Site | Enrolling by invitation |
Buffalo, New York, United States, 14202 | |
United States, North Carolina | |
Research Site | Recruiting |
Greensboro, North Carolina, United States, 27405 | |
United States, Ohio | |
Research Site | Withdrawn |
Toledo, Ohio, United States, 43623 | |
United States, Oregon | |
Research Site | Recruiting |
Portland, Oregon, United States, 97225 | |
United States, Tennessee | |
Research Site | Recruiting |
Knoxville, Tennessee, United States, 37922 | |
United States, Washington | |
Research Site | Recruiting |
Spokane, Washington, United States, 99204 |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT04746976 |
Other Study ID Numbers: |
US-VUM-11760 |
First Posted: | February 10, 2021 Key Record Dates |
Last Update Posted: | May 10, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/ |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Clinically isolated syndrome Relapsing-remitting disease Active secondary progressive disease |