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Purpose

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant must have a diagnosis of MS - Documentation that the participant was one of the following: 1. exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure). 2. unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date) - Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)

Exclusion Criteria

  • None NOTE: Other protocol defined Inclusion criteria may apply

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Diroximel Fumarate Pregnant women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
  • Drug: Diroximel Fumarate
    Administered as specified in the treatment arm.
    Other names:
    • VUMERITY
    • BIIB098
Disease Modifying Therapy (DMTs) Exposed Pregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
  • Drug: Avonex
    Administered as specified in the treatment arm.
    Other names:
    • BG9418
    • interferon beta-1a
  • Biological: Tysabri
    Administered as specified in the treatment arm.
    Other names:
    • Natalizumab
    • BG00002
DMTs Unexposed Pregnant women who were unexposed to DMT which is defined as either never received a DMT or discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP or discontinued a non-Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP.
Dimethyl Fumarate Pregnant women with MS who were exposed to DMF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
  • Drug: Dimethyl Fumarate
    Administered as specified in the treatment arm.
    Other names:
    • Tecfidera
    • DMF
    • BG00012
Women Without MS Pregnant women with external, general population comparators.

Recruiting Locations

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Contact:
303-724-8249

IQVIA US Office
Durham, North Carolina 27703
Contact:
833-569-2635

More Details

Status
Recruiting
Sponsor
Biogen

Study Contact

US Biogen Clinical Trial Center
866-633-4636
clinicaltrials@biogen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.