Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Biogen
Study ID
NCT05658497
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diroximel Fumarate — DRUG
    Administered as specified in the treatment arm.
  • Avonex — DRUG
    Administered as specified in the treatment arm.
  • Tysabri — BIOLOGICAL
    Administered as specified in the treatment arm.
  • Dimethyl Fumarate — DRUG
    Administered as specified in the treatment arm.

Study Details

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).

Key Dates

Start date
Oct 27, 2023
Status verified
Jul 2025
Primary completion
Jul 6, 2032
Completion
Jul 6, 2032

Study Design

Enrollment
908 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: Women Without MS
    Pregnant women with external, general population comparators.

Primary Outcome Measure

Number of Major Congenital Malformations (MCMs) [ Time Frame: Up to 52 weeks postdelivery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
303-724-8249
Anna Shah (PRINCIPAL_INVESTIGATOR)
IQVIA US OfficeDurhamNorth Carolina27703
833-569-2635
Sydney Willis (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
University of Colorado Anschutz Medical Campus· Aurora, COIQVIA US Office· Durham, NC

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