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Trial record 1 of 1 for:    US-VUM-11760
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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
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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]).

Condition or disease Intervention/treatment
Relapsing Forms of MS Drug: Diroximel Fumarate

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Diroximel Fumarate
Participants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled.
 Drug: Diroximel Fumarate
As described in the arm.
Other Names:
  • VUMERITY
  • BIIB098


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants on Treatment with DRF at 1 Year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Percentage of Participants on Treatment with DRF at 3 Months [ Time Frame: 3 months ]
  2. Percentage of Participants on Treatment with DRF at 2 Years [ Time Frame: 2 years ]
  3. Annualized Relapse Rate (ARR) with DRF [ Time Frame: At 1 and 2 years ]
  4. Percentage of Participants Relapsed [ Time Frame: At 1 and 2 years ]
  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Median Absolute Lymphocyte Count (ALC) Over Time [ Time Frame: Baseline up to 2 years ]
  14. Percent Change in Median ALC from Baseline [ Time Frame: Baseline up to 2 years ]
  15. 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 ]

Eligibility Criteria
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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
Study Population
Participants diagnosed with Relapsing forms of multiple sclerosis (RMS) that have been prescribed Diroximel Fumarate under standard clinical care.
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/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
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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
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
Clinically isolated syndrome
Relapsing-remitting disease
Active secondary progressive disease