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NCT05658497 · ClinicalTrials.gov registry record
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
A clinical trial of Multiple Sclerosis, sponsored by Biogen.
- Recruiting
- Registry status
- 908
- Enrollment target
- 7
- Study locations
NCT05658497: Recruiting study of Multiple Sclerosis, sponsored by Biogen.
NCT05658497 is a study of Multiple Sclerosis that is actively recruiting participants, run by Biogen. The registered enrollment target is 908 participants, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (56% higher). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05658497, a study of Multiple Sclerosis, is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- 908 participants
- Enrollment target
- 7
- Study locations
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).
Primary Outcome
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.
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 |
What NCT05658497 shows while recruiting
NCT05658497 is an observational study that tracks outcomes without assigning an intervention. The registered 908 participants enrollment target is mid-sized for trials with a published cap, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (56% higher).
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.
NCT05658497 lists 7 locations in 4 states (Other, Colorado, North Carolina).
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.
What interventions are being tested in trial NCT05658497?
The interventions under investigation include: Diroximel Fumarate (DRUG), Avonex (DRUG), Tysabri (BIOLOGICAL), Dimethyl Fumarate (DRUG).
Who is sponsoring clinical trial NCT05658497?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05658497's enrollment target sits among peer trials
908 31st of 315 higher than 285 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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