Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
NCT ID: NCT05658497
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
908 participants
OBSERVATIONAL
2023-10-27
2032-07-06
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Diroximel Fumarate
Administered as specified in the treatment arm.
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.
Avonex
Administered as specified in the treatment arm.
Tysabri
Administered as specified in the treatment arm.
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.
No interventions assigned to this group
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.
Dimethyl Fumarate
Administered as specified in the treatment arm.
Women Without MS
Pregnant women with external, general population comparators.
No interventions assigned to this group
Interventions
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Diroximel Fumarate
Administered as specified in the treatment arm.
Avonex
Administered as specified in the treatment arm.
Tysabri
Administered as specified in the treatment arm.
Dimethyl Fumarate
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documentation that the participant was one of the following:
1. 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).
2. 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)
Exclusion Criteria
FEMALE
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
IQVIA US Office
Durham, North Carolina, United States
Austin Hospital
Heidelberg, , Australia
Katholisches Klinikum Bochum
Bochum, North Rhine-Westphalia, Germany
St Vincent's University Hospital
Dublin, , Ireland
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Inselspital
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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272MS401
Identifier Type: -
Identifier Source: org_study_id
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