Observational study of exposure to baricitinib during pregnancy in US-based administrative claims data (I4V-MC-B036)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49807
• EU PAS number:
  EUPAS49806
• Study ID:
  49807
• Official title and acronym:
  Observational study of exposure to baricitinib during pregnancy in US-based administrative claims data (I4V-MC-B036)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The objective of this observational study is to evaluate the safety of baricitinib in pregnancy women and their linked infants. In addition to describing clinical and demographic characteristics of pregnancy women with evidence of exposure to baricitinib during pregnancy, this study will describe the following outcomes among the women and their linked infants, and compare the occurence of these outcomes to a similar cohort of unexposed pregnancy women and their infants: - major congenital malformations - recognized spontaneous abortions - stillbirths - small for gestational age - preterm birth
• Study status:
  Planned

Research institutions and networks

Institutions

Aetion

Spain

Study timelines

Date when funding contract was signed

Planned: 17/10/2022

Actual: 17/10/2022

Study start date

Planned: 30/06/2024

Date of final study report

Planned: 28/06/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

LY3009104 B036 NI PASS Protocol V2_ENCePP_Redacted.pdf

Regulatory

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