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Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
NCT05658497 · View on ClinicalTrials.gov ↗
Study 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 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 Studied
Interventions
- DRUG Diroximel Fumarate
- DRUG Avonex
- BIOLOGICAL Tysabri
- DRUG Dimethyl Fumarate
Study Locations (7)
Other
- Austin Hospital — Heidelberg
- St Vincent's University Hospital — Dublin
- Hospital Universitario Ramon y Cajal — Madrid
- Inselspital — Bern
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
North Carolina
- IQVIA US Office — Durham
North Rhine-Westphalia
- Katholisches Klinikum Bochum — Bochum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 908 participants |
| Start Date | 2023-10-27 |
| Est. Completion | 2032-07-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05658497
The ClinicalTrials.gov registry entry for NCT05658497 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 908 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 4 interventions — of which Diroximel Fumarate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05658497 reports 7 study locations spanning 4 distinct geographic areas — top geographies include Other, Colorado, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05658497 about?
NCT05658497 is a clinical study titled "Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)". 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 fi...
What is the current status of trial NCT05658497?
This trial is currently recruiting. The enrollment target is 908 participants. The study started on 2023-10-27. Estimated completion is 2032-07-06.
What conditions does trial NCT05658497 study?
This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05658497?
The interventions under investigation include: Diroximel Fumarate (DRUG), Avonex (DRUG), Tysabri (BIOLOGICAL), Dimethyl Fumarate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05658497?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05658497 being conducted?
This trial has 7 study locations across Colorado, North Carolina, North Rhine-Westphalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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