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Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks pregnancy outcomes, including major birth defects, after use of Vumerity (diroximel fumarate). It is for women with multiple sclerosis (MS), a disease that affects the brain and spinal cord. It compares outcomes with other groups, including women with MS who did not use MS disease-modifying medicines.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have a diagnosis of MS.
  • Records must show that you either took Vumerity during pregnancy or met the rules for not using MS disease-modifying medicines, which help slow MS.
  • For the Vumerity group, you must have taken it between 2 weeks after your last period started and the end of pregnancy. If exact dates are unknown, the 3-month stage of pregnancy must be known or estimated.
  • For the group not using MS medicines, you must have never used these medicines, stopped Vumerity at least 1 day before the study's estimated date of conception, or stopped another MS medicine not specified by the registry early enough.
  • For that other MS medicine, the required time is more than 5 times its half-life before estimated conception. A half-life is the time it takes for half the drug to leave your body.
  • The study estimates conception, when pregnancy begins, as 2 weeks after the first day of your last period.
  • You must know the pregnancy outcome, such as pregnancy loss or live birth.
  • Other study entry rules may apply.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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

    Study sites (2)

    CO

    NC