Status:
RECRUITING
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
Lead Sponsor:
AbbVie
Collaborating Sponsors:
PPD Development, LP
Conditions:
Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment
Eligibility:
FEMALE
Brief Summary
The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic a...
Eligibility Criteria
Inclusion
- Risankizumab-Exposed Cohort
- US resident.
- Current pregnancy.
- Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
- Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
- Diseased Comparison Cohort
- US resident.
- Current pregnancy.
- Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
- Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
Exclusion
- Risankizumab-Exposed Cohort
- Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
- Occurrence of pregnancy outcome prior to enrollment in the registry
- Diseased Comparison Cohort
- Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
- Occurrence of pregnancy outcome prior to enrollment in the registry
Key Trial Info
Start Date :
July 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2032
Estimated Enrollment :
818 Patients enrolled
Trial Details
Trial ID
NCT04846959
Start Date
July 30 2021
End Date
June 1 2032
Last Update
July 17 2025
Active Locations (2)
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1
Evidera, a PPD Business Unit /ID# 238688
Morrisville, North Carolina, United States, 27560-7200
2
PPD Development, LP /ID# 232134
Wilmington, North Carolina, United States, 28401-3331