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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05658497
Other study ID # 272MS401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 27, 2023
Est. completion date July 6, 2032

Study information

Verified date May 2024
Source Biogen
Contact US Biogen Clinical Trial Center
Phone 866-633-4636
Email clinicaltrials@biogen.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 908
Est. completion date July 6, 2032
Est. primary completion date July 6, 2032
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Diroximel Fumarate
Administered as specified in the treatment arm.
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.

Locations

Country Name City State
Germany Katholisches Klinikum Bochum Bochum Nordrhein Westfalen
Ireland St Vincent's University Hospital Dublin
Spain Hospital Universitario Ramon y Cajal Madrid
United States IQVIA US Office Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Germany,  Ireland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Major Congenital Malformations (MCMs) 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. Up to 52 weeks postdelivery
Secondary Number of Elective or Therapeutic Terminations Elective or therapeutic pregnancy termination is any induced or voluntary fetal loss during pregnancy. It will be subclassified as elective or therapeutic pregnancy terminations as whether it was due to a fatal anomaly or not. Up to 9 months of pregnancy
Secondary Number of Spontaneous Abortions Spontaneous abortion is defined as any loss of a fetus due to natural causes before 22 weeks of gestation. Before 22 weeks of gestation
Secondary Number of Fetal Deaths Including Still Birth Fetal death or stillbirth refers to the death of a fetus prior to complete expulsion or extraction from its mother at or after 22 weeks of gestation. Death is indicated by the fact that, after such separation, the fetus does not show any evidence of life (e.g., heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles). Fetal death occurring at or after 22 weeks but before 28 weeks of gestation is considered an early fetal loss. Fetal death occurring at or after 28 weeks is considered a late fetal loss. At or after 22 weeks of gestation
Secondary Number of Live Births A live birth refers to a complete expulsion or extraction from its mother of a surviving neonate breathing, or showing any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord has been cut or the placenta is attached. Any live birth before 37 weeks of gestation will be considered premature birth. Any live birth at or after 37 weeks but before 42 weeks of gestation will be considered full-term birth. Any live birth at or after 42 weeks of gestation will be considered post-term birth. Up to delivery (approximately 10 months)
Secondary Number of Ectopic Pregnancies Up to 9 months of pregnancy
Secondary Number of Molar Pregnancies Up to 9 months of pregnancy
Secondary Number of Maternal Deaths Maternal death is death of a pregnant woman during pregnancy, labor, or delivery. Registry will also report maternal deaths that occur up to 12 weeks postdelivery. Up to 12 weeks postdelivery
Secondary Number of Neonatal Deaths Neonatal death is death occurring in a neonate prior to 28 days of life. Prior to 28 days postdelivery
Secondary Number of Perinatal Deaths Perinatal death is death occurring at or after 28 days of life and prior to 12 weeks of life. At or after 28 days to 12 weeks postdelivery
Secondary Number of Infant Deaths Infant death is death occurring between 12 and 52 weeks of life, inclusive. Between 12 to 52 weeks postdelivery
Secondary Number of Serious or Opportunistic Infections in Liveborn Children Up to 52 weeks postdelivery
Secondary Number of Infants with Abnormal Postnatal Growth and Development Infant growth measurements will be used to estimate gender-specific weight-for-length, head circumference-for-age, length-for-age, and weight-for-age percentiles. Developmental milestones (i.e., social/emotional, language/communication, neurocognitive, movement/physical development) will be used to determine results of infant status (i.e., below, above, or at age-appropriate achievement). Up to 52 weeks postdelivery
Secondary Number of Participants with Pregnancy Complications Pregnancy complications may include incidences of pre-eclampsia, eclampsia, pregnancy-induced hypertension, preterm labor, gestational diabetes and placenta previa. Up to 9 months of pregnancy
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