Status: Ongoing First registered on: 16/03/2021
Last updated on: 12/05/2022
1. Study identification
EU PAS Register NumberEUPAS39775
Official titlePregnancy 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 title acronym
Study typeObservational study
Brief description of the studyThe study aim is to evaluate the safety of risankizumab during pregnancy in women with psoriasis.
Was this study requested by a regulator?Yes: EMA, United States
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableP16-751
2. Research centres and Investigator details
Coordinating study entity
Centre nameReagan-Udall Foundation
Centre location1900 L Street NW, Suite 835, Washington, DC, 20036
Details of (Primary) lead investigator
Title Dr
Last name AbbVie
First name Clinical Trial Disclosure
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/05/202101/07/2021
Start date of data collection31/01/202221/03/2022
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/2030
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAbbVie100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name AbbVie
First name Clinical Trial Disclosure
Address line 11 North Waukegan Road
Address line 2 
Address line 3 
CityNorth Chicago 
Postcode 
CountryUnited States
Phone number (incl. country code)0018006339110 
Alternative phone number 
Fax number (incl. country code) 
Email address CT.Disclosures@abbvie.com
Public Enquiries
Title Dr 
Last name AbbVie 
First name Clinical Trial Disclosure 
Address line 11 North Waukegan Road 
Address line 2 
Address line 3 
CityNorth Chicago 
Postcode 
CountryUnited States 
Phone number (incl. country code)0018006339110 
Alternative phone number 
Fax number (incl. country code) 
Email address CT.Disclosures@abbvie.com 
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