Clinical trial NCT05658497: Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Official title: Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Pregnancy
Relapsing forms of MS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 908
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Major Congenital Malformations (MCMs)
timeFrame: Up to 52 weeks postdelivery
Secondary outcomes:
measure: Number of Elective or Therapeutic Terminations
timeFrame: Up to 9 months of pregnancy
measure: Number of Spontaneous Abortions
timeFrame: Before 22 weeks of gestation
measure: Number of Fetal Deaths Including Still Birth
timeFrame: At or after 22 weeks of gestation
measure: Number of Live Births
timeFrame: Up to delivery (approximately 10 months)
measure: Number of Ectopic Pregnancies
timeFrame: Up to 9 months of pregnancy
measure: Number of Molar Pregnancies
timeFrame: Up to 9 months of pregnancy
measure: Number of Maternal Deaths
timeFrame: Up to 12 weeks postdelivery
measure: Number of Neonatal Deaths
timeFrame: Prior to 28 days postdelivery
measure: Number of Perinatal Deaths
timeFrame: At or after 28 days to 12 weeks postdelivery
measure: Number of Infant Deaths
timeFrame: Between 12 to 52 weeks postdelivery
measure: Number of Serious or Opportunistic Infections in Liveborn Children
timeFrame: Up to 52 weeks postdelivery
measure: Number of Infants with Abnormal Postnatal Growth and Development
timeFrame: Up to 52 weeks postdelivery
measure: Number of Participants with Pregnancy Complications
timeFrame: Up to 9 months of pregnancy
Other outcomes:
Locations:
city: Durham
country: United States
facility: IQVIA US Office
state: North Carolina
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum
state: Nordrhein Westfalen
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: