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Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

NCT05658497 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 908

Last updated 2025-08-01

No results posted yet for this 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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2032-07-06
Completion
2032-07-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • Ireland
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05658497 on ClinicalTrials.gov