Registry based observational study to assess pregnancy and infant outcomes following exposure to baricitinib in pregnancy (I4V-MC-B035)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50000
• EU PAS number:
  EUPAS49999
• Study ID:
  50000
• Official title and acronym:
  Registry based observational study to assess pregnancy and infant outcomes following exposure to baricitinib in pregnancy (I4V-MC-B035)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Planned

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 30/06/2023

Study start date

Planned: 30/06/2024

Date of final study report

Planned: 30/06/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

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