Multiple SclerosisNCT05658497
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
An observational study of Multiple Sclerosis, run by Biogen at 8 sites in 7 countries.
Trial summary
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Diroximel Fumarate, Avonex and Tysabri
- How many people
- 908 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 27 Oct 2023to 6 Jul 2032
- How long will I take part?
- 52 Weeks
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include pregnant female participants with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP up through any time during pregnancy and compared with pregnancies among women with MS who were exposed to DMF, women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), women with MS who were unexposed to DMTs, and women without MS. Participants will be classified into 2 enrolment types, Prospective and Retrospective. Prospective registration:a report of a pregnancy enrolled prior to knowledge of the pregnancy outcome, including prior to the detection of a congenital malformation at prenatal testing. Women who enrol after any knowledge of the pregnancy outcome will be enrolled as retrospective cases but will not be included in the primary analysis, i.e.,pregnancies with a prenatal testing result indicative of any congenital malformation/pregnancies with known outcomes at time of initial report.
Who may be able to join
- Participant must have a diagnosis of MS
- Documentation that the participant was one of the following:
- exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
- unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date)
- Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)
Who cannot join
- None
- NOTE: Other protocol defined Inclusion criteria may apply
Trial locations and contacts
8 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
8 sites in 7 countries
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
303-724-8249
Anna Shah
- Recruiting
IQVIA US Office
Durham, North Carolina, 27703
833-569-2635
Sydney Willis
Germany1 site, 1 recruiting
- Recruiting
Katholisches Klinikum Bochum
Bochum, North Rhine-Westphalia, 44791
+492345092420
Kerstin Hellwig
Ireland1 site, 1 recruiting
- Recruiting
St Vincent's University Hospital
Dublin, DO4 T6F4
+35312773592
Christopher McGuigan
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
+34913368397
Lucienne Costa-Frossard
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital
Bern, 3010
41316641250
Helly Hammer
United Kingdom1 site, 1 recruiting
- Recruiting
Salford Care Organization
Salford, Greater Manchester, M68HD
+441612060534
David Rog
About this study
Official title: Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).
- Conditions
- Multiple Sclerosis
- Being tested
- Diroximel Fumarate, Avonex, Tysabri, Dimethyl Fumarate
- Keywords
- Pregnancy, Relapsing forms of 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.
AvonexDrug
Also called BG9418, interferon beta-1a
Administered as specified in the treatment arm.
TysabriBiological
Also called Natalizumab, BG00002
Administered as specified in the treatment arm.
Dimethyl FumarateDrug
Also called Tecfidera, DMF, BG00012
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Diroximel Fumarate | Pregnant women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the end of pregnancy. Receives: Drug: Diroximel Fumarate | |
| Disease Modifying Therapy (DMTs) Exposed | Pregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy. Receives: Drug: Avonex; Biological: Tysabri | |
| DMTs Unexposed | Pregnant women who were unexposed to DMT which is defined as either never received a DMT or discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP or discontinued a non-Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP. | |
| Dimethyl Fumarate | Pregnant women with MS who were exposed to DMF at any time from 2 weeks after the first day of their LMP through the end of pregnancy. Receives: Drug: Dimethyl Fumarate | |
| Women Without MS | Pregnant women with external, general population comparators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Major Congenital Malformations (MCMs)
MCMs include abnormalities in structural development that are medically or cosmetically significant are present at birth, and persist in postnatal life unless or until repaired as evaluated by independent advisors used throughout the registry.
Measured: Up to 52 weeks postdelivery
Secondary outcomes (13)
Number of Elective or Therapeutic Terminations
Elective or therapeutic pregnancy termination is any induced or voluntary fetal loss during pregnancy. It will be subclassified as elective or therapeutic pregnancy terminations as whether it was due to a fatal anomaly or not.
Measured: Up to 9 months of pregnancy
Number of Spontaneous Abortions
Spontaneous abortion is defined as any loss of a fetus due to natural causes before 22 weeks of gestation.
Measured: Before 22 weeks of gestation
Number of Fetal Deaths Including Still Birth
Fetal death or stillbirth refers to the death of a fetus prior to complete expulsion or extraction from its mother at or after 22 weeks of gestation. Death is indicated by the fact that, after such separation, the fetus does not show any evidence of life (e.g., heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles). Fetal death occurring at or after 22 weeks but before 28 weeks of gestation is considered an early fetal loss. Fetal death occurring at or after 28 weeks is considered a late fetal loss.
Measured: At or after 22 weeks of gestation
Number of Live Births
A live birth refers to a complete expulsion or extraction from its mother of a surviving neonate breathing, or showing any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord has been cut or the placenta is attached. Any live birth before 37 weeks of gestation will be considered premature birth. Any live birth at or after 37 weeks but before 42 weeks of gestation will be considered full-term birth. Any live birth at or after 42 weeks of gestation will be considered post-term birth.
Measured: Up to delivery (approximately 10 months)
Number of Ectopic Pregnancies
Measured: Up to 9 months of pregnancy
Number of Molar Pregnancies
Measured: Up to 9 months of pregnancy
Number of Maternal Deaths
Maternal death is death of a pregnant woman during pregnancy, labor, or delivery. Registry will also report maternal deaths that occur up to 12 weeks postdelivery.
Measured: Up to 12 weeks postdelivery
Number of Neonatal Deaths
Neonatal death is death occurring in a neonate prior to 28 days of life.
Measured: Prior to 28 days postdelivery
Number of Perinatal Deaths
Perinatal death is death occurring at or after 28 days of life and prior to 12 weeks of life.
Measured: At or after 28 days to 12 weeks postdelivery
Number of Infant Deaths
Infant death is death occurring between 12 and 52 weeks of life, inclusive.
Measured: Between 12 to 52 weeks postdelivery
Number of Serious or Opportunistic Infections in Liveborn Children
Measured: Up to 52 weeks postdelivery
Number of Infants with Abnormal Postnatal Growth and Development
Infant growth measurements will be used to estimate gender-specific weight-for-length, head circumference-for-age, length-for-age, and weight-for-age percentiles. Developmental milestones (i.e., social/emotional, language/communication, neurocognitive, movement/physical development) will be used to determine results of infant status (i.e., below, above, or at age-appropriate achievement).
Measured: Up to 52 weeks postdelivery
Number of Participants with Pregnancy Complications
Pregnancy complications may include incidences of pre-eclampsia, eclampsia, pregnancy-induced hypertension, preterm labor, gestational diabetes and placenta previa.
Measured: Up to 9 months of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start27 Oct 2023
- Primary completion6 Jul 2032 (estimated)
- Study completion6 Jul 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
- Prospective
- Enrolment
- 908 participants (estimated)
- Target duration
- 52 Weeks
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
- NCT05658497
- Sponsor's protocol ID
- 272MS401
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2022
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT05658497
- Acronym / sponsor ID
- 272MS401
- Conditions
- Multiple Sclerosis
- Keywords
- Pregnancy, Relapsing forms of MS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 908 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 6 Jul 2032 (estimated)
- Study completion
- 6 Jul 2032 (estimated)
- First posted
- 20 Dec 2022 (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 objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Diroximel Fumarate | – | Drug: Diroximel FumaratePregnant women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the end of pregnancy. |
| Disease Modifying Therapy (DMTs) Exposed | – | Drug: Avonex, Biological: TysabriPregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy. |
| DMTs Unexposed | – | –Pregnant women who were unexposed to DMT which is defined as either never received a DMT or discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP or discontinued a non-Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP. |
| Dimethyl Fumarate | – | Drug: Dimethyl FumaratePregnant women with MS who were exposed to DMF at any time from 2 weeks after the first day of their LMP through the end of pregnancy. |
| Women Without MS | – | –Pregnant women with external, general population comparators. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant female participants with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP up through any time during pregnancy and compared with pregnancies among women with MS who were exposed to DMF, women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), women with MS who were unexposed to DMTs, and women without MS. Participants will be classified into 2 enrolment types, Prospective and Retrospective. Prospective registration:a report of a pregnancy enrolled prior to knowledge of the pregnancy outcome, including prior to the detection of a congenital malformation at prenatal testing. Women who enrol after any knowledge of the pregnancy outcome will be enrolled as retrospective cases but will not be included in the primary analysis, i.e.,pregnancies with a prenatal testing result indicative of any congenital malformation/pregnancies with known outcomes at time of initial report.
Key inclusion criteria (5 listed)
- Participant must have a diagnosis of MS
- Documentation that the participant was one of the following:
- Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)
Key exclusion criteria (2 listed)
- None
- NOTE: Other protocol defined Inclusion 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 |
| AvonexAlso: BG9418, interferon beta-1aAdministered as specified in the treatment arm. | Drug | Disease Modifying Therapy (DMTs) Exposed |
| TysabriAlso: Natalizumab, BG00002Administered as specified in the treatment arm. | Biological | Disease Modifying Therapy (DMTs) Exposed |
| Dimethyl FumarateAlso: Tecfidera, DMF, BG00012Administered as specified in the treatment arm. | Drug | Dimethyl Fumarate |
Primary outcome
Number of Major Congenital Malformations (MCMs)
Time frame: Up to 52 weeks postdelivery
MCMs include abnormalities in structural development that are medically or cosmetically significant are present at birth, and persist in postnatal life unless or until repaired as evaluated by independent advisors used throughout the registry.
13 secondary outcomes
Number of Elective or Therapeutic Terminations
Time frame: Up to 9 months of pregnancy
Number of Spontaneous Abortions
Time frame: Before 22 weeks of gestation
Number of Fetal Deaths Including Still Birth
Time frame: At or after 22 weeks of gestation
Number of Live Births
Time frame: Up to delivery (approximately 10 months)
Number of Ectopic Pregnancies
Time frame: Up to 9 months of pregnancy
Number of Molar Pregnancies
Time frame: Up to 9 months of pregnancy
Number of Maternal Deaths
Time frame: Up to 12 weeks postdelivery
Number of Neonatal Deaths
Time frame: Prior to 28 days postdelivery
Number of Perinatal Deaths
Time frame: At or after 28 days to 12 weeks postdelivery
Number of Infant Deaths
Time frame: Between 12 to 52 weeks postdelivery
Number of Serious or Opportunistic Infections in Liveborn Children
Time frame: Up to 52 weeks postdelivery
Number of Infants with Abnormal Postnatal Growth and Development
Time frame: Up to 52 weeks postdelivery
Number of Participants with Pregnancy Complications
Time frame: Up to 9 months of pregnancy
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 11 Aug 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.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
8 sites in 7 countries: 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 8 sites in 7 countries.
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 5 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, Germany, Ireland, Spain and 2 more countries. 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?
Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. 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 11 Aug 2026.