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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47188
• EU PAS number:
  EUPAS39775
• Study ID:
  47188
• Official title and acronym:
  Pregnancy Exposures and Outcomes in Women with Psoriasis 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 description:
  The study aim is to evaluate the safety of risankizumab during pregnancy in women with psoriasis.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Reagan-Udall Foundation

Study timelines

Date when funding contract was signed

Planned: 31/05/2021

Actual: 01/07/2021

Study start date

Planned: 31/01/2022

Actual: 21/03/2022

Date of final study report

Planned: 31/10/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p16751-protocol-pmos abstract-18oct2020_Redacted

Updated protocol

riskmgtsystem-pam-p16751-protocol-pmos_v1.4_abstract_Redacted

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

P16-751