Relapsing Forms of MSNCT04746976
Study of Diroximel Fumarate in the Real-World Setting
An observational study of Relapsing Forms of MS, run by Biogen at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Forms of MS
- What is being tested?
- Diroximel Fumarate
- Type of treatment
- Pill or oral medicine
- How many people
- 75 participants
- Where
- 18 sitesUnited States
- Study dates
- 1 Mar 2021to 14 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with Relapsing forms of multiple sclerosis (RMS) that have been prescribed Diroximel Fumarate under standard clinical care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jacobs School of Medicine and Biomedical Sciences
Buffalo, New York, 14202
Geisinger Medical Center
Danville, Pennsylvania, 17822
Glendale Neurological Associates, PC
Farmington, Michigan, 48071
CentraState Healthcare System - Linda Cardinale MS Center
Freehold, New Jersey, 07728
Cone Health
Greensboro, North Carolina, 27405
UTHealth Neurosciences Texas Medical Center II
Houston, Texas, 77030
St. Luke's Neurology
Kansas City, Missouri, 64111
Hope Neurology
Knoxville, Tennessee, 37922
MS Center at St Barnabas
Livingston, New Jersey, 07039
Norton Neuroscience Institute
Louisville, Kentucky, 40207
Multiple Sclerosis Center JSUMC
Neptune City, New Jersey, 07753
Riverside Neurology Specialists
Newport News, Virginia, 23601
Memorial Healthcare
Owosso, Michigan, 48867
Providence Brain and Spine Institute
Portland, Oregon, 97225
Providence Medical Research Center
Spokane, Washington, 99204
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Regina Berkovich MD Phd Inc
West Hollywood, California, 90048
About this study
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)
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]).
- Conditions
- Relapsing Forms of MS
- Being tested
- Diroximel Fumarate
- Keywords
- Clinically isolated syndrome, Multiple Sclerosis, Relapsing forms of Multiple Sclerosis, Active secondary progressive disease
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diroximel FumarateDrug
Also called VUMERITY, BIIB098
As described in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Diroximel Fumarate | Participants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled. Receives: Drug: Diroximel Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants on Treatment with DRF at 1 Year
Measured: 1 year
Secondary outcomes (15)
Percentage of Participants on Treatment with DRF at 3 Months
Measured: 3 months
Percentage of Participants on Treatment with DRF at 2 Years
Measured: 2 years
Annualized Relapse Rate (ARR) with DRF
Measured: At 1 and 2 years
Percentage of Participants Relapsed
Measured: 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
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 32 months
Median Absolute Lymphocyte Count (ALC) Over Time
Measured: Baseline up to 2 years
Percent Change in Median ALC from Baseline
Measured: 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
Measured: Up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Mar 2021
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Why it stopped: Sponsor's Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Forms of MSStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746976
- Sponsor's protocol ID
- US-VUM-11760
- Status last verified
- May 2023
- First submitted
- 5 Feb 2021
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04746976
- Acronym / sponsor ID
- US-VUM-11760
- Conditions
- Relapsing Forms of MS
- Keywords
- Clinically isolated syndrome, Multiple Sclerosis, Relapsing forms of Multiple Sclerosis, Active secondary progressive disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 75 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diroximel Fumarate | – | Drug: Diroximel FumarateParticipants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with Relapsing forms of multiple sclerosis (RMS) that have been prescribed Diroximel Fumarate under standard clinical care.
Key inclusion criteria (2 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diroximel FumarateAlso: VUMERITY, BIIB098As described in the arm. | Drug | Diroximel Fumarate |
Primary outcome
Percentage of Participants on Treatment with DRF at 1 Year
Time frame: 1 year
15 secondary outcomes
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
Change in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire
Time frame: Baseline up to 2 years
Change in Disability, as Measured by Patient Determined Disease Steps (PDDS)
Time frame: Baseline up to 2 years
Change in Work Productivity and Activity Impairment Due to Multiple Sclerosis (WPAI- MS) Scores from Baseline
Time frame: Baseline up to 2 years
Number of Participants with Gastrointestinal (GI) Adverse Events (AEs)
Time frame: Up to 32 months
Number of Participants with AEs Leading to Treatment Discontinuation
Time frame: Up to 32 months
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 32 months
Number of Participants categorized by the types of actions taken to mitigate GI AEs
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
Results and safety
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Related trials for Relapsing Forms of MS
Active, not recruitingObservational study
A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
Multiple Sclerosis
Active, not recruitingPhase 4
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Multiple Sclerosis
RecruitingPhase 4
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Forms of MS, run by Biogen at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants on Treatment with DRF at 1 Year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.