A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
- Conditions
- Multiple Sclerosis
- Interventions
- Registration Number
- NCT05688436
- Lead Sponsor
- Biogen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1178
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-DRF Interferon beta Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Alemtuzumab Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Glatiramer acetate Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Ocrelizumab Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Natalizumab Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Ofatumumab Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Peginterferon beta-1a Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Ponesimod Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Diroximel Fumarate (DRF) Diroximel Fumarate Pregnant women with MS who were exposed to DRF. Non-DRF Fingolimod Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Ozanimod Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. Non-DRF Siponimod Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF.
- Primary Outcome Measures
Name Time Method Number of Major Congenital Malformations (MCMs) Up to 52 weeks postdelivery MCMs includes abnormalities in structural development that are medically or cosmetically significant are present at birth and persist in postnatal life unless or until repaired.
- Secondary Outcome Measures
Name Time Method Number of Preterm Births At or before the 37 weeks of gestation Preterm birth is defined as a live birth at or before the 37th week of gestation.
Number of Spontaneous Abortions Before 20 weeks of gestation Spontaneous abortion is defined as the loss of a fetus due to natural causes before 20th week of gestation.
Number of Stillbirths At or after the 20 weeks of gestation Stillbirth is defined as the loss of pregnancy at or after the 20th week of gestation.
Number of Small for Gestational Age (SGA) Up to 52 weeks postdelivery SGA is defined as birthweight below the 10th percentile for gestational age.
Trial Locations
- Locations (1)
OptumInsight
🇺🇸Eden Prairie, Minnesota, United States