Multiple SclerosisNCT05767736
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, run by Biogen at 1 site in United States.
Trial summary
The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Diroximel Fumarate, Dimethyl Fumarate and Disease-Modifying Therapies (DMTs)
- How many people
- 10,500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2024to 1 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) at the initiation of the treatment and participating in Big Multiple Sclerosis Data (BMSD) network registry.
Who may be able to join
- Participants with MS treated with at least 1 dose of Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), and whose data are captured in the BMSD network will be included in the study.
Who cannot join
- None
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta interferons, or glatiramer acetate]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.
- Conditions
- Multiple Sclerosis
- Being tested
- Diroximel Fumarate, Dimethyl Fumarate, Disease-Modifying Therapies (DMTs)
- 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
Administered as specified in the treatment arm.
Dimethyl FumarateDrug
Also called Tecfidera, DMF, BG00012
Administered as specified in the treatment arm.
Disease-Modifying Therapies (DMTs)Drug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Vumerity Cohort | Participants who have been prescribed Vumerity as a newly initiating treatment and not previously treated with Tecfidera are selected and the available data is collected retrospectively. Receives: Drug: Diroximel Fumarate | |
| Tecfidera Cohort | Participants who have been prescribed Tecfidera as a newly initiating treatment and not previously treated with Vumerity are selected and the available data is collected retrospectively. Receives: Drug: Dimethyl Fumarate | |
| Vumerity/Tecfidera Switch Cohort | Participants who have been treated with Tecfidera and then switched to Vumerity as per routine medical care are selected and the available data is collected retrospectively. Receives: Drug: Diroximel Fumarate; Drug: Dimethyl Fumarate | |
| Selected Disease Modifying Therapies (DMTs) Treated Cohort | Participants who have been prescribed with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) and are not previously treated with Vumerity or Tecfidera are selected and the available data is collected retrospectively. Receives: Drug: Disease-Modifying Therapies (DMTs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts
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, and results in a congenital anomaly/birth defect. The incidence rate of confirmed SAEs, will include but not be limited to malignancies and serious and opportunistic infections among participants with MS who are treated with Vumerity, Tecfidera, and other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate).
Measured: Up to 10 years
Secondary outcomes (1)
Hazard Ratio of Confirmed SAEs in Vumerity, Tecfidera, or Vumerity/Tecfidera Switch Cohorts Versus Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer acetate) Cohort
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, and results in a congenital anomaly/birth defect. The incidence rate of confirmed SAEs, will include but not be limited to malignancies and serious and opportunistic infections among participants with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate).
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start8 Jun 2024
- Primary completion1 Dec 2032 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Retrospective
- Enrolment
- 10,500 participants (estimated)
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
- NCT05767736
- Sponsor's protocol ID
- 272MS403
- Other IDs
- EUPAS1000000285
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2023
- Last updated
- 26 Oct 2026
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
- ClinicalTrials.gov ID
- NCT05767736
- Acronym / sponsor ID
- 272MS403
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,500 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 1 Dec 2032 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 14 Mar 2023 (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 estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta interferons, or glatiramer acetate]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vumerity Cohort | – | Drug: Diroximel FumarateParticipants who have been prescribed Vumerity as a newly initiating treatment and not previously treated with Tecfidera are selected and the available data is collected retrospectively. |
| Tecfidera Cohort | – | Drug: Dimethyl FumarateParticipants who have been prescribed Tecfidera as a newly initiating treatment and not previously treated with Vumerity are selected and the available data is collected retrospectively. |
| Vumerity/Tecfidera Switch Cohort | – | Drug: Diroximel Fumarate, Drug: Dimethyl FumarateParticipants who have been treated with Tecfidera and then switched to Vumerity as per routine medical care are selected and the available data is collected retrospectively. |
| Selected Disease Modifying Therapies (DMTs) Treated Cohort | – | Drug: Disease-Modifying Therapies (DMTs)Participants who have been prescribed with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) and are not previously treated with Vumerity or Tecfidera are selected and the available data is collected retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) at the initiation of the treatment and participating in Big Multiple Sclerosis Data (BMSD) network registry.
Key inclusion criteria (1 listed)
- Participants with MS treated with at least 1 dose of Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), and whose data are captured in the BMSD network will be included in the study.
Key exclusion criteria (2 listed)
- None
- 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, BIIB098Administered as specified in the treatment arm. | Drug | Vumerity Cohort, Vumerity/Tecfidera Switch Cohort |
| Dimethyl FumarateAlso: Tecfidera, DMF, BG00012Administered as specified in the treatment arm. | Drug | Tecfidera Cohort, Vumerity/Tecfidera Switch Cohort |
| Disease-Modifying Therapies (DMTs)Administered as specified in the treatment arm. | Drug | Selected Disease Modifying Therapies (DMTs) Treated Cohort |
Primary outcome
Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts
Time frame: Up to 10 years
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, and results in a congenital anomaly/birth defect. The incidence rate of confirmed SAEs, will include but not be limited to malignancies and serious and opportunistic infections among participants with MS who are treated with Vumerity, Tecfidera, and other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate).
1 secondary outcome
Hazard Ratio of Confirmed SAEs in Vumerity, Tecfidera, or Vumerity/Tecfidera Switch Cohorts Versus Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer acetate) Cohort
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 1 site 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts (time frame: Up to 10 years). 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 Oct 2026.