A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Diroximel Fumarate (DRF) Pregnant women with MS who were exposed to DRF 12 months prior to last menstrual period (LMP). |
Drug: Diroximel Fumarate
Administered as specified in the treatment arm.
Other Names:
|
Non-DRF Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF 12 months prior to LMP. |
Biological: Alemtuzumab
Administered as specified in the treatment arm.
Drug: Fingolimod
Administered as specified in the treatment arm.
Drug: Glatiramer acetate
Administered as specified in the treatment arm.
Biological: Interferon beta
Administered as specified in the treatment arm.
Biological: Natalizumab
Administered as specified in the treatment arm.
Other Names:
Biological: Ocrelizumab
Administered as specified in the treatment arm.
Biological: Peginterferon beta-1a
Administered as specified in the treatment arm.
Drug: Siponimod
Administered as specified in the treatment arm.
|
Non-DMT Pregnant women with MS who were not exposed to DMTs. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
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.
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Presence of MS.
Key Exclusion Criteria:
- 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | OptumInsight | Eden Prairie | Minnesota | United States | 55344-2503 |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 272MS402