Exploring Diroximel Fumarate Real-world Experience in Canada and Israel (EXPER-CA/IL)

May 9, 2023 updated by: Biogen

A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-CA+IL 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); to assess the impact of DRF on disability; to assess treatment satisfaction with DRF; to explore the real-world safety profile of DRF (i.e., gastrointestinal [GI] tolerability, lymphocyte dynamics, adverse events [AEs] leading to discontinuation, and serious adverse events [SAEs].

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Lady Davis Carmel Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Kfar Saba, Israel
        • Meir Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center
      • Tel-Aviv, Israel
        • Tel Aviv Sourasky Medical
      • Tel-Hashomer, Israel
        • Sheba medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with RMS that have been prescribed DRF under standard clinical care.

Description

Key Inclusion Criteria:

  • Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the prescribing information.
  • DRF prescribed and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose.

Key Exclusion Criteria:

  • History of gastric bypass or required use of feeding tubes.
  • Current enrollment in any interventional study or in any study which may conflict with this study, per the discretion of the principal investigator (PI) and Biogen
  • Have received prior treatment with DRF (more than 7 days before enrollment).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Diroximel Fumarate (DRF)
Participants with a confirmed diagnosis of MS who are newly prescribed DRF in routine clinical practice and who satisfy the approved therapeutic indication for DRF will be enrolled.
Drug: Diroximel Fumarate
Administered as specified in the treatment arm.
Other Names:
  • VUMERITY
  • BIIB098

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants on Treatment with DRF
Time Frame: Year 1
Year 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants on Treatment with DRF
Time Frame: Month 3
Month 3
Percentage of Participants on Treatment with DRF
Time Frame: Year 2
Year 2
Annualized Relapse Rate (ARR) with DRF
Time Frame: Year 1 and 2
For ARR at 1 year, the total number of days on study will be defined as the number of days since date of first dose to 1 year (365 days) if participant stay on DRF treatment for longer than 1 year, or the date of first dose to the date of DRF discontinuation if participant die or withdraw from the study prior to 1 year. For ARR at 2 years, the total number of days on study is defined as the number of days since the date of first dose to the date of DRF discontinuation. The relapse rate will be calculated as the total number of relapses experienced divided by the total number of days on DRF treatment, and the ratio multiplied by 365.
Year 1 and 2
Percentage of Participants Relapsed
Time Frame: Year 1 and 2
Year 1 and 2
Change in Cognitive Processing Speed Test (CPST) Score
Time Frame: Baseline, Year 1 and 2
Change in CPST will be assessed using the Konectom application. Cognitive function will be evaluated based on elements of attention, psychomotor speed, visual processing and working memory. Cognitive function is assessed by having the participant pair abstract symbols with specific numbers using a key as a guide. Higher number of correct responses indicates better cognition
Baseline, Year 1 and 2
Change in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire
Time Frame: Baseline, Year 1 and 2
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.
Baseline, Year 1 and 2
Change in Disability, as Measured by Expanded Disability Status Scale (EDSS)
Time Frame: Baseline, Year 1 and 2
The EDSS measures disability status on a scale ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]), with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Baseline, Year 1 and 2
Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Time Frame: Baseline, Year 1 and 2
TSQM Version 1.4 is comprised of 14 questions that provide scores on four scales: effectiveness (3 items), side effects (5 items), convenience (3 items) and global satisfaction (3 items). The scale scores are transformed and range from 0 to 100. Higher scores indicate greater satisfaction.
Baseline, Year 1 and 2
Number of Participants with Gastrointestinal (GI) Adverse Events (AEs)
Time Frame: Up to Month 32
An AE is any untoward medical occurrence in a participant or clinical investigation 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, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Up to Month 32
Number of Participants with AEs Leading to Treatment Discontinuation
Time Frame: Up to Month 32
An AE is any untoward medical occurrence in a participant or clinical investigation 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, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Up to Month 32
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to Month 32
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 (a life-threatening event), 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.
Up to Month 32
Number of Participants with Relevant Concomitant Medication Use
Time Frame: Up to Month 32
The concomitant medication may include GI symptom medication, coronavirus disease of 2019 (COVID-19) vaccine, etc.
Up to Month 32
Number of Participants Categorized by the Types of Actions Taken Due to GI AEs
Time Frame: Up to Month 32
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.
Up to Month 32
Median Absolute Lymphocyte Count (ALC) Over Time
Time Frame: Baseline, Month 6, Year 1 and 2
Baseline, Month 6, Year 1 and 2
Percent Change from Baseline in Median ALC
Time Frame: Baseline, Month 6, Year 1 and 2
Baseline, Month 6, Year 1 and 2
Number of Participants with Lymphopenia According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE) Severity Grading
Time Frame: Up to Month 32
Up to Month 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA-VUM-11892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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