Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate) (NCT05658497) — USA Trial Details

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Diroximel FumarateAvonexTysabriDimethyl Fumarate

Diroximel Fumarate: Administered as specified in the treatment arm.

Avonex: Administered as specified in the treatment arm.

Tysabri: Administered as specified in the treatment arm.

Dimethyl Fumarate: Administered as specified in the treatment arm.

Study summary

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).

Eligibility

Sex

FEMALE

Min age

—

Max age

—

Healthy volunteers

No

Key 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) Key Exclusion Criteria: \- None NOTE: Other protocol defined Inclusion criteria may apply

Primary outcome measure(s)

Number of Major Congenital Malformations (MCMs) — Up to 52 weeks postdelivery
MCMs include abnormalities in structural development that are medically or cosmetically significant are present at birth, and persist in postnatal life unless or until repaired as evaluated by independent advisors used throughout the registry.

Trial sites (8)

Facility	City	Region	Status
University of Colorado Anschutz Medical Campus	Aurora	Colorado	Recruiting
IQVIA US Office	Durham	North Carolina	Recruiting
Austin Hospital	Heidelberg	Australia	Recruiting
Katholisches Klinikum Bochum	Bochum	North Rhine-Westphalia	Recruiting
St Vincent's University Hospital	Dublin	Ireland	Recruiting
Hospital Universitario Ramon y Cajal	Madrid	Spain	Recruiting
Inselspital	Bern	Switzerland	Recruiting
Salford Care Organization	Salford	Greater Manchester	Recruiting

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