Pregnancy Exposures and Outcomes in Women with Inflammatory Bowel Disease Treated with Risankizumab: A Cohort Study Utilizing Large Electronic Healthcare Databases with Mother-Baby Linkage in the United States

Study identification

• EU PAS number:
  EUPAS1000000283
• Study ID:
  1000000283
• Official title and acronym:
  Pregnancy Exposures and Outcomes in Women with Inflammatory Bowel Disease Treated with Risankizumab: A Cohort Study Utilizing Large Electronic Healthcare Databases with Mother-Baby Linkage in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned:12/07/2022

Study start date

Actual:07/04/2025

Data analysis start date

Actual:07/04/2025

Date of final study report

Planned:30/06/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

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)

Other study registration identification numbers and links

P23-653