Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorBiogen
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must have a diagnosis of MS
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)
Disqualifiers
None
Trial population
The study population will include pregnant female participants with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP up through any time during pregnancy and compared with pregnancies among women with MS who were exposed to DMF, women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), women with MS who were unexposed to DMTs, and women without MS. Participants will be classified into 2 enrolment types, Prospective and Retrospective. Prospective registration:a report of a pregnancy enrolled prior to knowledge of the pregnancy outcome, including prior to the detection of a congenital malformation at prenatal testing. Women who enrol after any knowledge of the pregnancy outcome will be enrolled as retrospective cases but will not be included in the primary analysis, i.e.,pregnancies with a prenatal testing result indicative of any congenital malformation/pregnancies with known outcomes at time of initial report.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diroximel Fumarate
DrugAdministered as specified in the treatment arm.
Avonex
DrugAdministered as specified in the treatment arm.
Tysabri
Biological/VaccineAdministered as specified in the treatment arm.
Dimethyl Fumarate
DrugAdministered as specified in the treatment arm.
Treatment groups
908 Participants
are divided into 5 treatment groupsGroup A: Diroximel Fumarate1 intervention
Group B: Disease Modifying Therapy (DMTs) Exposed2 interventions
Group C: DMTs Unexposed0 interventions
Group D: Dimethyl Fumarate1 intervention
Group E: Women Without MS0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 52 weeks postdeliverySecondary outcomes
1
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.
Time frame
Up to 9 months of pregnancy2
Number of Spontaneous Abortions
Spontaneous abortion is defined as any loss of a fetus due to natural causes before 22 weeks of gestation.
Time frame
Before 22 weeks of gestation3
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.
Time frame
At or after 22 weeks of gestation4
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.
Time frame
Up to delivery (approximately 10 months) Source ClinicalTrials.gov