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

Multiple Sclerosis Clinical Trial

Official title:

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688436
• Other study ID #: 272MS402
• Status: Recruiting
• Start date: September 24, 2021
• Est. completion date: January 17, 2031

Study information

• Verified date: October 2023
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1178
• Est. completion date: January 17, 2031
• Est. primary completion date: January 17, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Diroximel Fumarate
Administered as specified in the treatment arm.

Biological:
• Alemtuzumab
Administered as specified in the treatment arm.

Drug:
• Fingolimod
Administered as specified in the treatment arm.
• Glatiramer acetate
Administered as specified in the treatment arm.

Biological:
• Interferon beta
Administered as specified in the treatment arm.
• Natalizumab
Administered as specified in the treatment arm.
• Ocrelizumab
Administered as specified in the treatment arm.
• Ofatumumab
Administered as specified in the treatment arm.

Drug:
• Ozanimod
Administered as specified in the treatment arm.

Biological:
• Peginterferon beta-1a
Administered as specified in the treatment arm.

Drug:
• Ponesimod
Administered as specified in the treatment arm.
• Siponimod
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
United States	OptumInsight	Eden Prairie	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Small for Gestational Age (SGA)	SGA is defined as birthweight below the 10th percentile for gestational age.	Up to 52 weeks postdelivery