Observational Cohort Study of Safety of Etrasimod During Pregnancy in US Claims Databases (C5041042)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000832
• Study ID:
  1000000832
• Official title and acronym:
  Observational Cohort Study of Safety of Etrasimod During Pregnancy in US Claims Databases (C5041042)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This non-interventional study (NIS) is designated as a post-authorization safety study (PASS) and is a commitment to the US FDA. This is an observational cohort study using two US-based administrative healthcare claims databases, each of which will be used to identify pregnancy episodes among individuals with UC who are exposed to etrasimod during pregnancy or who are unexposed to etrasimod but exposed to other advanced UC treatments during pregnancy.; ; Research question: Is there an increased risk of adverse pregnancy and/or infant outcomes in individuals who are exposed to etrasimod during pregnancy?; ; Primary objective: Describe the prevalence of major congenital malformations (MCMs) in infants born alive to pregnant individuals with a diagnosis of ulcerative colitis (UC) who are (1) exposed to etrasimod during pregnancy (Etrasimod Cohort) and (2) unexposed to etrasimod but exposed to other advanced UC treatments during pregnancy (Other Advanced UC Treatments Cohort) and compare the prevalence between cohorts if sample size permits ; ; Secondary objective: Describe the prevalence of pregnancy (spontaneous abortion, pregnancy termination, gestational hypertension, pre-eclampsia, eclampsia, and stillbirth) and infant (preterm birth and small for gestational age) outcomes among individuals in the Etrasimod Cohort and the Other Advanced UC Treatments Cohort and compare the prevalence between cohorts if sample size permits;
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Optum; Carelon

Study timelines

Date when funding contract was signed

Planned:20/12/2023

Actual:20/12/2023

Study start date

Planned:17/11/2026

Data analysis start date

Planned:01/06/2031

Date of interim report, if expected

Planned:30/11/2027

Date of final study report

Planned:31/03/2032

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

C5041042