A Post-Marketing Safety Study to Evaluate the Safety of VELSIPITY® (Etrasimod) Exposure During Pregnancy (C5041043)

Study identification

• EU PAS number:
  EUPAS1000000672
• Study ID:
  1000000672
• Official title and acronym:
  A Post-Marketing Safety Study to Evaluate the Safety of VELSIPITY® (Etrasimod) Exposure During Pregnancy (C5041043)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  This study will address the gap in information on the safety of etrasimod when used in pregnancy in terms of risk of maternal, fetal, and infant outcomes. ; This non-interventional study is designated as a post-authorization safety study (PASS) and is a post marketing requirement of the FDA.; The research question is: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to etrasimod during pregnancy?; The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) among pregnant individuals with moderate-to-severe ulcerative colitis (UC) who are exposed to etrasimod during pregnancy. ; The secondary objectives of the study are:; • To estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with moderate-to-severe UC who are exposed to etrasimod during pregnancy.; • To contextualize the prevalence of outcomes among pregnant individuals who are exposed to etrasimod during pregnancy and to estimate the prevalence of all outcomes of interest among pregnant individuals with moderate-to-severe UC who are not exposed to etrasimod during pregnancy.; • If sample size permits, to estimate the risk ratio (RR) for each study outcome comparing the outcomes of pregnant individuals with moderate-to-severe UC who are exposed to etrasimod with those who are not exposed to etrasimod.;
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

CorEvitas

Study timelines

Date when funding contract was signed

Planned:16/10/2023

Study start date

Planned:30/09/2025

Date of final study report

Planned:30/09/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C5041043