NCT05658497

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 908 (estimated)
• Sponsor: Biogen · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Diroximel Fumarate	Administered as specified in the treatment arm.
DRUG	Avonex	Administered as specified in the treatment arm.
BIOLOGICAL	Tysabri	Administered as specified in the treatment arm.
DRUG	Dimethyl Fumarate	Administered as specified in the treatment arm.

Timeline

• Start date: 2023-10-27
• Primary completion: 2032-07-06
• Completion: 2032-07-06
• First posted: 2022-12-20
• Last updated: 2025-08-01

Locations

7 sites across 6 countries: United States, Australia, Germany, Ireland, Spain, Switzerland

Regulatory

• FDA-regulated drug study