Observational Study of Pregnancy and Infant Outcomes Among Women Exposed to Mirikizumab During Pregnancy in US-based Administrative Claims Data (I6T-MC-B003)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105675
• EU PAS number:
  EUPAS105674
• Study ID:
  105675
• Official title and acronym:
  Observational Study of Pregnancy and Infant Outcomes Among Women Exposed to Mirikizumab During Pregnancy in US-based Administrative Claims Data (I6T-MC-B003)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Planned

Research institutions and networks

Institutions

Aetion

Spain

Study timelines

Date when funding contract was signed

Actual: 09/05/2023

Study start date

Planned: 26/05/2025

Date of final study report

Planned: 31/12/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

LY3074828 B003 Protocol Version 1_Redacted (1).pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)