Menu
Recruiting NCT05658497

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

— Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diroximel Fumarate, Avonex, Tysabri, Dimethyl Fumarate.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Germany, Ireland, Spain +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

Overview

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).

Interventions

  • Drug Diroximel Fumarate
    Administered as specified in the treatment arm.
  • Drug Avonex
    Administered as specified in the treatment arm.
  • Biological Tysabri
    Administered as specified in the treatment arm.
  • Drug Dimethyl Fumarate
    Administered as specified in the treatment arm.

Primary outcome measures

  • Number of Major Congenital Malformations (MCMs) [Time frame: Up to 52 weeks postdelivery]
Secondary outcome measures (12)
  • Number of Elective or Therapeutic Terminations [Time frame: Up to 9 months of pregnancy]
  • Number of Spontaneous Abortions [Time frame: Before 22 weeks of gestation]
  • Number of Fetal Deaths Including Still Birth [Time frame: At or after 22 weeks of gestation]
  • Number of Live Births [Time frame: Up to delivery (approximately 10 months)]
  • Number of Ectopic Pregnancies [Time frame: Up to 9 months of pregnancy]
  • Number of Molar Pregnancies [Time frame: Up to 9 months of pregnancy]
  • Number of Maternal Deaths [Time frame: Up to 12 weeks postdelivery]
  • Number of Neonatal Deaths [Time frame: Prior to 28 days postdelivery]
  • Number of Perinatal Deaths [Time frame: At or after 28 days to 12 weeks postdelivery]
  • Number of Infant Deaths [Time frame: Between 12 to 52 weeks postdelivery]
  • Number of Serious or Opportunistic Infections in Liveborn Children [Time frame: Up to 52 weeks postdelivery]
  • Number of Infants with Abnormal Postnatal Growth and Development [Time frame: Up to 52 weeks postdelivery]

Eligibility criteria

Inclusion criteria

  • Participant must have a diagnosis of MS
  • Documentation that the participant was one of the following:
  • 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).
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • University of Colorado Anschutz Medical Campus — Aurora
  • IQVIA US Office — Durham
Australia · 1 center
  • Austin Hospital — Heidelberg
Germany · 1 center
  • Katholisches Klinikum Bochum — Bochum
Ireland · 1 center
  • St Vincent's University Hospital — Dublin
Spain · 1 center
  • Hospital Universitario Ramon y Cajal — Madrid
Switzerland · 1 center
  • Inselspital — Bern

Identifiers

NCT: NCT05658497 · 272MS401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗