RECRUITING

A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS. This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are: * Those who took DRF during their pregnancy * Those who took other drugs for RMS during their pregnancy, but not DRF * Those who did not take any drugs for RMS during their pregnancy The main question researchers want to learn about in this study is: • How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth. Researchers will also learn more about: * Loss of the baby before 20 weeks of pregnancy * Loss of the baby at and after 20 weeks of pregnancy * How many babies are born early (at or before 37 weeks) * How many babies are small for their age while in the participant's uterus * How many babies are born with any sign of life This study will be done as follows: * Participants with RMS can join this study if they become pregnant from 29th October 2019 to 31st July 2030. Information will start being collected when the participant decides to join the study. * The participants' medical records will be reviewed 2 times during the study - once when the study is halfway done, and one at the end of the study. * Each participant will be in the study until the end of their pregnancy. Each baby will be in the study for up to 1 year after birth. * The study is planned to end by 30th April 2031.

Official Title

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Quick Facts

Study Start:2021-09-24
Study Completion:2031-01-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05688436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
  2. * Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated LMP.
  3. * Presence of MS.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

Medical Director
STUDY_DIRECTOR
Biogen

Study Locations (Sites)

OptumInsight
Eden Prairie, Minnesota, 55344-2503
United States

Collaborators and Investigators

Sponsor: Biogen

  • Medical Director, STUDY_DIRECTOR, Biogen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-24
Study Completion Date2031-01-17

Study Record Updates

Study Start Date2021-09-24
Study Completion Date2031-01-17

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy
  • Relapsing forms of Multiple Sclerosis (MS)

Additional Relevant MeSH Terms

  • Multiple Sclerosis