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)
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)
6. Study drug(s) information
Product NameSkyrizi
CountryUnited States
Substance INN(s)RISANKIZUMAB
7. Medical conditions to be studied
Medical condition(s)Yes
Psoriasis
8. Population under study
Age
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Sex
Female
Other population
Pregnant women
9. Number of subjects
Estimated total number of subjects600
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
IMEDS-DD, United States
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
The study aim is to evaluate the safety of risankizumab during pregnancy in women
with psoriasis.
Are there primary outcomes?Yes
The primary outcome of this cohort study is major congenital malformations of the
infant among live birth pregnancies.
Are there secondary outcomes?Yes
Secondary outcomes include the following:
● Pregnancy outcomes: live birth, spontaneous abortion, elective abortion,
stillbirth
● Infant outcomes: premature birth, small for gestational age (SGA), neonatal
deaths, serious infections
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Data for infants will be collected for up to 1 year after birth to allow adequate follow up
time to detect major congenital malformations in the infants, the primary outcome of
interest.
15. Data analysis plan
Please provide a brief summary of the analysis method
This study will estimate the incidence (cumulative risks) of pregnancy outcomes,
including live births, spontaneous abortions, elective abortion, and stillbirths and will
compare the occurrence of these events among risankizumab-exposed women with those among the matched comparator biologic-exposed women. AbbVie will use a log binomial distribution with robust variance using generalized estimating equations to estimate the effects of exposure (cumulative risk ratios and 95% confidence intervals) to risankizumab.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
