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Research summary · AI summary · not yet reviewedHuman studyObservationalTrial registry record – peer review not applicable
Impact of Diroximel Fumarate on Major Congenital Malformations in Pregnant Women with MS
An observational study aims to estimate the prevalence of major congenital malformations (MCMs) in pregnant women with multiple sclerosis (MS), comparing those taking diroximel fumarate (DRF) to those exposed to other disease-modifying therapies (DMTs).
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This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
This research is important for understanding potential risks of taking DRF during pregnancy for women with MS, informing clinical practices and patient decision-making.
What this does not prove
Results from the study have not been posted yet, and planned enrollment and endpoints are not findings at this stage.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 1178 · basis not reported
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
Original sources
Supporting passages (11)
study designDRF is an approved drug that is used to treat people with RMS.\n\nThis is known as an \"observational\" study, which collects health information about study participants without changing their medical care.
subjectsThe 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.
sample sizeThe study includes data in adult women with multiple sclerosis on pregnancies happening between October 29th, 2019 and July 31st, 2030.
randomized"eligibilityCriteria": "Key Inclusion Criteria:\n\n* Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.\n* 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.\n* Presence of MS.\n\nKey Exclusion Criteria:\n\n\\- 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.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.",
research categories"briefSummary": "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.
relevant ms types"Relapsing forms of Multiple Sclerosis (MS)"
intervention"Drug: Diroximel Fumarate"
comparatorPregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF.
primary endpoint"measure": "Number of Major Congenital Malformations (MCMs)",
findingsThe main goal of this study is to collect birth and health information from 3 groups of participants and their babies.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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