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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05658497
Registration number
NCT05658497
Ethics application status
Date submitted
12/12/2022
Date registered
20/12/2022
Date last updated
1/08/2025
Titles & IDs
Public title
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
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Scientific title
Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
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Secondary ID [1]
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272MS401
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Diroximel Fumarate
Treatment: Drugs - Avonex
Treatment: Other - Tysabri
Treatment: Drugs - Dimethyl Fumarate
Diroximel Fumarate - Pregnant women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
Disease Modifying Therapy (DMTs) Exposed - Pregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
DMTs Unexposed - Pregnant women who were unexposed to DMT which is defined as either never received a DMT or discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP 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.
Dimethyl Fumarate - Pregnant women with MS who were exposed to DMF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.
Women Without MS - Pregnant women with external, general population comparators.
Treatment: Drugs: Diroximel Fumarate
Administered as specified in the treatment arm.
Treatment: Drugs: Avonex
Administered as specified in the treatment arm.
Treatment: Other: Tysabri
Administered as specified in the treatment arm.
Treatment: Drugs: Dimethyl Fumarate
Administered as specified in the treatment arm.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Major Congenital Malformations (MCMs)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 52 weeks postdelivery
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Secondary outcome [1]
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Number of Elective or Therapeutic Terminations
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 9 months of pregnancy
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Secondary outcome [2]
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Number of Spontaneous Abortions
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Assessment method [2]
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Spontaneous abortion is defined as any loss of a fetus due to natural causes before 22 weeks of gestation.
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Timepoint [2]
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Before 22 weeks of gestation
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Secondary outcome [3]
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Number of Fetal Deaths Including Still Birth
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Assessment method [3]
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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.
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Timepoint [3]
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At or after 22 weeks of gestation
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Secondary outcome [4]
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Number of Live Births
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Assessment method [4]
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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.
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Timepoint [4]
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Up to delivery (approximately 10 months)
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Secondary outcome [5]
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Number of Ectopic Pregnancies
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Assessment method [5]
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Timepoint [5]
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Up to 9 months of pregnancy
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Secondary outcome [6]
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Number of Molar Pregnancies
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Assessment method [6]
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Timepoint [6]
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Up to 9 months of pregnancy
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Secondary outcome [7]
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Number of Maternal Deaths
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 12 weeks postdelivery
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Secondary outcome [8]
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Number of Neonatal Deaths
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Assessment method [8]
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Neonatal death is death occurring in a neonate prior to 28 days of life.
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Timepoint [8]
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Prior to 28 days postdelivery
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Secondary outcome [9]
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Number of Perinatal Deaths
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Assessment method [9]
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Perinatal death is death occurring at or after 28 days of life and prior to 12 weeks of life.
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Timepoint [9]
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At or after 28 days to 12 weeks postdelivery
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Secondary outcome [10]
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Number of Infant Deaths
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Assessment method [10]
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Infant death is death occurring between 12 and 52 weeks of life, inclusive.
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Timepoint [10]
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Between 12 to 52 weeks postdelivery
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Secondary outcome [11]
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Number of Serious or Opportunistic Infections in Liveborn Children
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Assessment method [11]
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Timepoint [11]
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Up to 52 weeks postdelivery
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Secondary outcome [12]
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Number of Infants with Abnormal Postnatal Growth and Development
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Assessment method [12]
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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).
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Timepoint [12]
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Up to 52 weeks postdelivery
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Secondary outcome [13]
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Number of Participants with Pregnancy Complications
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Assessment method [13]
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Pregnancy complications may include incidences of pre-eclampsia, eclampsia, pregnancy-induced hypertension, preterm labor, gestational diabetes and placenta previa.
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Timepoint [13]
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Up to 9 months of pregnancy
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Eligibility
Key inclusion criteria
Key
* 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)
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- None
NOTE: Other protocol defined Inclusion criteria may apply
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/07/2032
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Actual
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Sample size
Target
908
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Country [3]
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Germany
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State/province [3]
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North Rhine-Westphalia
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Country [4]
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Ireland
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State/province [4]
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Dublin
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Country [5]
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Spain
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State/province [5]
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Madrid
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Country [6]
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Switzerland
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State/province [6]
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biogen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/study/NCT05658497
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Biogen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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US Biogen Clinical Trial Center
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Address
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Country
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Phone
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866-633-4636
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05658497
Download to PDF