Multiple SclerosisNCT05688436
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
An observational study of Multiple Sclerosis, run by Biogen at 1 site in United States.
Trial summary
In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Diroximel Fumarate, Alemtuzumab and Fingolimod
- How many people
- 1,178 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2021to 17 Jan 2031
- 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: The participants included in this study will be drawn from the population of adult women with MS who become pregnant between 29 October 2019 and 31 July 2030.
Who may be able to join
- Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
- Continuous medical Optum Research Database (ORD) and pharmacy (ORD and Market Clarity) coverage for a minimum of 6 months prior to and including the estimated LMP.
- Presence of MS.
Who cannot join
- Pregnancies will be excluded from this study if they are exposed to any known teratogens from 5 half-lives (rounded up to the nearest whole day) before the estimated date of conception through the end of the relevant exposure window.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS.
This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are:
Read more
- Those who took DRF during their pregnancy
- Those who took disease-modifying therapies (DMTs) for RMS during their pregnancy, but not DRF. DMTs are drugs that slow how the disease develops over time, not just relieve symptoms.
- Those who did not take any drugs for RMS during their pregnancy
The main question researchers want to learn about in this study is:
- How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth.
In this study, researchers will measure how often the following outcomes happen and compare them between groups:
- Loss of pregnancy before 20 weeks
- Loss of pregnancy at or after 20 weeks (stillbirth)
- Babies born early (before 37 weeks)
- Babies who are smaller than expected for the stage of pregnancy
- Live births
This study will be done as follows:
- The study includes data in adult women with multiple sclerosis on pregnancies happening between October 29th, 2019 and July 31st, 2030. Information will start being collected when the participant decides to join the study.
- Medical records and clinical notes will be reviewed at the end of the study.
- The study will include information from pregnancy through delivery, and for babies up to 1 year after birth.
- The study is planned to end by 30th April 2031.
Read the detailed description
The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups; to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups; and to estimate the incidence of live birth and compare the incidence between the DRF and comparator groups.
- Conditions
- Multiple Sclerosis
- Being tested
- Diroximel Fumarate, Alemtuzumab, Fingolimod, Glatiramer acetate, Interferon beta
- Keywords
- Pregnancy, Relapsing forms of Multiple Sclerosis (MS)
- 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.
AlemtuzumabBiological
Administered as specified in the treatment arm.
FingolimodDrug
Administered as specified in the treatment arm.
Glatiramer acetateDrug
Administered as specified in the treatment arm.
Interferon betaBiological
Administered as specified in the treatment arm.
NatalizumabBiological
Also called Tysabri, BG00002
Administered as specified in the treatment arm.
OcrelizumabBiological
Administered as specified in the treatment arm.
OfatumumabBiological
Administered as specified in the treatment arm.
OzanimodDrug
Administered as specified in the treatment arm.
Peginterferon beta-1aBiological
Administered as specified in the treatment arm.
PonesimodDrug
Administered as specified in the treatment arm.
SiponimodDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Diroximel Fumarate (DRF) | Pregnant women with MS who were exposed to DRF. Receives: Drug: Diroximel Fumarate | |
| Non-DRF | Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Receives: Biological: Alemtuzumab; Drug: Fingolimod; Drug: Glatiramer acetate; Biological: Interferon beta; Biological: Natalizumab; Biological: Ocrelizumab; Biological: Ofatumumab; Drug: Ozanimod; Biological: Peginterferon beta-1a; Drug: Ponesimod; Drug: Siponimod | |
| Non-DMT | Pregnant women with MS who were not exposed to DMTs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Major Congenital Malformations (MCMs)
MCMs includes abnormalities in structural development that are medically or cosmetically significant are present at birth and persist in postnatal life unless or until repaired.
Measured: Up to 52 weeks postdelivery
Secondary outcomes (5)
Number of Spontaneous Abortions
Spontaneous abortion is defined as the loss of a fetus due to natural causes before 20th week of gestation.
Measured: Before 20 weeks of gestation
Number of Preterm Births
Preterm birth is defined as a live birth at or before the 37th week of gestation.
Measured: At or before the 37 weeks of gestation
Number of Stillbirths
Stillbirth is defined as the loss of pregnancy at or after the 20th week of gestation.
Measured: At or after the 20 weeks of gestation
Number of Small for Gestational Age (SGA)
SGA is defined as birthweight below the 10th percentile for gestational age.
Measured: Up to 52 weeks postdelivery
Number of Live Births
Livebirth is defined as a delivered fetus with any sign of life (e.g., voluntary movement, heartbeat) regardless of gestational weeks.
Measured: Up to delivery (approximately 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start24 Sep 2021
- Primary completion17 Jan 2031 (estimated)
- Study completion17 Jan 2031 (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
- Prospective
- Enrolment
- 1,178 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
- NCT05688436
- Sponsor's protocol ID
- 272MS402
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2023
- Last updated
- 15 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
- ClinicalTrials.gov ID
- NCT05688436
- Acronym / sponsor ID
- 272MS402
- Conditions
- Multiple Sclerosis
- Keywords
- Pregnancy, Relapsing forms of Multiple Sclerosis (MS)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,178 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 17 Jan 2031 (estimated)
- Study completion
- 17 Jan 2031 (estimated)
- First posted
- 18 Jan 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.
In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS.
This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are:
- Those who took DRF during their pregnancy
- Those who took disease-modifying therapies (DMTs) for RMS during their pregnancy, but not DRF. DMTs are drugs that slow how the disease develops over time, not just relieve symptoms.
- Those who did not take any drugs for RMS during their pregnancy
The main question researchers want to learn about in this study is:
- How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth.
In this study, researchers will measure how often the following outcomes happen and compare them between groups:
- Loss of pregnancy before 20 weeks
- Loss of pregnancy at or after 20 weeks (stillbirth)
- Babies born early (before 37 weeks)
- Babies who are smaller than expected for the stage of pregnancy
- Live births
This study will be done as follows:
- The study includes data in adult women with multiple sclerosis on pregnancies happening between October 29th, 2019 and July 31st, 2030. Information will start being collected when the participant decides to join the study.
- Medical records and clinical notes will be reviewed at the end of the study.
- The study will include information from pregnancy through delivery, and for babies up to 1 year after birth.
- The study is planned to end by 30th April 2031.
Detailed description
The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups; to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups; and to estimate the incidence of live birth and compare the incidence between the DRF and comparator groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diroximel Fumarate (DRF) | – | Drug: Diroximel FumaratePregnant women with MS who were exposed to DRF. |
| Non-DRF | – | Biological: Alemtuzumab, Drug: Fingolimod, Drug: Glatiramer acetate, Biological: Interferon beta, Biological: Natalizumab, Biological: Ocrelizumab, Biological: Ofatumumab, Drug: Ozanimod, Biological: Peginterferon beta-1a, Drug: Ponesimod, Drug: SiponimodPregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. |
| Non-DMT | – | –Pregnant women with MS who were not exposed to DMTs. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The participants included in this study will be drawn from the population of adult women with MS who become pregnant between 29 October 2019 and 31 July 2030.
Key inclusion criteria (3 listed)
- Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
- Continuous medical Optum Research Database (ORD) and pharmacy (ORD and Market Clarity) coverage for a minimum of 6 months prior to and including the estimated LMP.
- Presence of MS.
Key exclusion criteria (2 listed)
- Pregnancies will be excluded from this study if they are exposed to any known teratogens from 5 half-lives (rounded up to the nearest whole day) before the estimated date of conception through the end of the relevant exposure window.
- 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 | Diroximel Fumarate (DRF) |
| AlemtuzumabAdministered as specified in the treatment arm. | Biological | Non-DRF |
| FingolimodAdministered as specified in the treatment arm. | Drug | Non-DRF |
| Glatiramer acetateAdministered as specified in the treatment arm. | Drug | Non-DRF |
| Interferon betaAdministered as specified in the treatment arm. | Biological | Non-DRF |
| NatalizumabAlso: Tysabri, BG00002Administered as specified in the treatment arm. | Biological | Non-DRF |
| OcrelizumabAdministered as specified in the treatment arm. | Biological | Non-DRF |
| OfatumumabAdministered as specified in the treatment arm. | Biological | Non-DRF |
| OzanimodAdministered as specified in the treatment arm. | Drug | Non-DRF |
| Peginterferon beta-1aAdministered as specified in the treatment arm. | Biological | Non-DRF |
| PonesimodAdministered as specified in the treatment arm. | Drug | Non-DRF |
| SiponimodAdministered as specified in the treatment arm. | Drug | Non-DRF |
Primary outcome
Number of Major Congenital Malformations (MCMs)
Time frame: Up to 52 weeks postdelivery
MCMs includes abnormalities in structural development that are medically or cosmetically significant are present at birth and persist in postnatal life unless or until repaired.
5 secondary outcomes
Number of Spontaneous Abortions
Time frame: Before 20 weeks of gestation
Number of Preterm Births
Time frame: At or before the 37 weeks of gestation
Number of Stillbirths
Time frame: At or after the 20 weeks of gestation
Number of Small for Gestational Age (SGA)
Time frame: Up to 52 weeks postdelivery
Number of Live Births
Time frame: Up to delivery (approximately 10 months)
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 15 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 3 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 15 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 Major Congenital Malformations (MCMs) (time frame: Up to 52 weeks postdelivery). 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 15 Oct 2026.