A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Description

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

Conditions

Multiple Sclerosis

Study Overview

Study Details

Study overview

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Eden Prairie

OptumInsight, Eden Prairie, Minnesota, United States, 55344-2503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 49 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Biogen,

Medical Director, STUDY_DIRECTOR, Biogen

Study Record Dates

2031-01-17