Ulcerative Colitis
Conditions
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.
Interventions
DRUGOzanimod
Women with UC exposed to ozanimod during pregnancy
DRUGConventional therapy
Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy
DRUGAdvanced therapy
Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of major congenital malformations among infants | Up to 10 years | To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy. |
Secondary
| Measure | Time frame |
|---|---|
| Number of stillbirths | Up to 10 years |
| Number of participants with pre-eclampsia | Up to 10 years |
| Number of participants with eclampsia | Up to 10 years |
| Number of preterm births | Up to 10 years |
| Number of infants small for gestational age | Up to 10 years |
| Number of serious or opportunistic infections in liveborn infants up to 1 year of age | Up to 10 years |
| Number of spontaneous abortions | Up to 10 years |
| Number of infant developmental deficiencies | Up to 10 years |
| Number of neonatal hospitalizations | Up to 10 years |
| Number of infant deaths | Up to 10 years |
| Number of neonatal deaths | Up to 10 years |
| Number of perinatal deaths | Up to 10 years |
| Number of infant postnatal growth deficiencies | Up to 10 years |
Countries
United States
Outcome results
None listed