Assessing pregnancy outcomes in women taking Diroximel Fumarate
Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
This study looks at whether taking Diroximel Fumarate during pregnancy affects the health of babies and compares those results to women who used other treatments for Multiple Sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1178 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Biogen Industry-sponsored |
| Locations | 1 site (Eden Prairie, Minnesota) |
| Trial ID | NCT05688436 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the prevalence of major congenital malformations in women exposed to Diroximel Fumarate during pregnancy and compare these outcomes with those of women exposed to other treatments for Multiple Sclerosis. It will also evaluate the incidence of spontaneous abortion, preterm birth, stillbirth, and small for gestational age infants among the different groups. The study will gather data from women with Multiple Sclerosis who have had their last menstrual period between October 2019 and July 2030 and have continuous medical coverage. By analyzing these outcomes, the study seeks to provide insights into the safety of Diroximel Fumarate during pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a diagnosis of Multiple Sclerosis who have been exposed to Diroximel Fumarate.
Not a fit: Patients who are pregnant and have been exposed to known teratogens during the relevant exposure window will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical information on the safety of Diroximel Fumarate for pregnant women with Multiple Sclerosis, potentially guiding treatment decisions.
How similar studies have performed: Other studies have explored pregnancy outcomes in women with Multiple Sclerosis, but this specific comparison involving Diroximel Fumarate is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Last menstrual period (LMP) between 29 October 2019 and 31 July 2030. * Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated LMP. * Presence of MS. Key Exclusion Criteria: \- Pregnancies will be excluded from this study if they are exposed to any known teratogens from the beginning of baseline through the end of the relevant exposure window. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Eden Prairie, Minnesota
- OptumInsight — Eden Prairie, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: US Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
- Phone: 866-633-4636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.