Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Biogen

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Drug: Dimethyl Fumarate; Drug: Avonex; Drug: Diroximel Fumarate; Biological: Tysabri

Study type: Observational

Funder types: Industry

Identifiers

NCT05658497

272MS401

Details and patient eligibility

About

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).

Enrollment: 908 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participant must have a diagnosis of MS

• Documentation that the participant was one of the following:

  1. exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
  2. unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date)

• Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)

Key Exclusion Criteria:

• None

NOTE: Other protocol defined Inclusion criteria may apply

Trial design

908 participants in 5 patient groups

Diroximel Fumarate

Description:

Pregnant women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.

Treatment:

Drug: Diroximel Fumarate

Disease Modifying Therapy (DMTs) Exposed

Description:

Pregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy.

Treatment:

Biological: Tysabri

Drug: Avonex

DMTs Unexposed

Description:

Pregnant women who were unexposed to DMT which is defined as either never received a DMT or discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP or discontinued a non-Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP.

Dimethyl Fumarate

Description:

Pregnant women with MS who were exposed to DMF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.

Treatment:

Drug: Dimethyl Fumarate

Women Without MS

Description:

Pregnant women with external, general population comparators.