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

Study Overview
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Brief Summary
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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.

Official Title
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Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Diroximel Fumarate
* Biological: Alemtuzumab
* Drug: Fingolimod
* Drug: Glatiramer acetate
* Biological: Interferon beta
* Biological: Natalizumab
* Biological: Ocrelizumab
* Biological: Ofatumumab
* Drug: Ozanimod
* Biological: Peginterferon beta-1a
* Drug: Ponesimod
* Drug: Siponimod


Participation Criteria
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Eligibility Criteria
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Key Inclusion 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diroximel Fumarate (DRF)<br>Pregnant women with MS who were exposed to DRF. | Drug: Diroximel Fumarate<br>* Administered as specified in the treatment arm.<br>* Other names: BIIB098;|
| Non-DRF<br>Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF. | Biological: Alemtuzumab<br>* Administered as specified in the treatment arm.<br>Drug: Fingolimod<br>* Administered as specified in the treatment arm.<br>Drug: Glatiramer acetate<br>* Administered as specified in the treatment arm.<br>Biological: Interferon beta<br>* Administered as specified in the treatment arm.<br>Biological: Natalizumab<br>* Administered as specified in the treatment arm.<br>* Other names: BG00002;Biological: Ocrelizumab<br>* Administered as specified in the treatment arm.<br>Biological: Ofatumumab<br>* Administered as specified in the treatment arm.<br>Drug: Ozanimod<br>* Administered as specified in the treatment arm.<br>Biological: Peginterferon beta-1a<br>* Administered as specified in the treatment arm.<br>Drug: Ponesimod<br>* Administered as specified in the treatment arm.<br>Drug: Siponimod<br>* Administered as specified in the treatment arm.<br>|
| Non-DMT<br>Pregnant women with MS who were not exposed to DMTs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Major Congenital Malformations (MCMs) | 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. | Up to 52 weeks postdelivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Spontaneous Abortions | Spontaneous abortion is defined as the loss of a fetus due to natural causes before 20th week of gestation. | Before 20 weeks of gestation | 
| Number of Preterm Births | Preterm birth is defined as a live birth at or before the 37th week of gestation. | At or before the 37 weeks of gestation | 
| Number of Stillbirths | Stillbirth is defined as the loss of pregnancy at or after the 20th week of gestation. | At or after the 20 weeks of gestation | 
| Number of Small for Gestational Age (SGA) | SGA is defined as birthweight below the 10th percentile for gestational age. | Up to 52 weeks postdelivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Relapsing forms of Multiple Sclerosis (MS)