Clinical trial NCT06126835: A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
Official title: Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 2828
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with UC who became pregnant between June 1, 2021 and September 1, 2030

Brief summary: The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 49 years on date of conception
* Date of conception between June 1, 2021 and September 1, 2030
* Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode
* Diagnosis of UC during the 12 months prior to conception through the end of the first trimester

Exclusion Criteria:

* • Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)

Primary outcomes:
measure: Prevalence of major congenital malformations among infants
timeFrame: Up to 10 years
Secondary outcomes:
measure: Number of spontaneous abortions
timeFrame: Up to 10 years
measure: Number of stillbirths
timeFrame: Up to 10 years
measure: Number of participants with pre-eclampsia
timeFrame: Up to 10 years
measure: Number of participants with eclampsia
timeFrame: Up to 10 years
measure: Number of preterm births
timeFrame: Up to 10 years
measure: Number of infants small for gestational age
timeFrame: Up to 10 years
measure: Number of serious or opportunistic infections in liveborn infants up to 1 year of age
timeFrame: Up to 10 years
measure: Number of infant postnatal growth deficiencies
timeFrame: Up to 10 years
measure: Number of infant developmental deficiencies
timeFrame: Up to 10 years
measure: Number of neonatal hospitalizations
timeFrame: Up to 10 years
measure: Number of infant deaths
timeFrame: Up to 10 years
measure: Number of neonatal deaths
timeFrame: Up to 10 years
measure: Number of perinatal deaths
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: OptumInsight Life Sciences Inc
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: