Actively Recruiting
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
Led by AbbVie · Updated on 2025-07-17
818
Participants Needed
2
Research Sites
565 weeks
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations. Approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States. Participants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery There may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.
CONDITIONS
Official Title
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be a resident of the United States
- Must be currently pregnant
- Must have a diagnosis of plaque psoriasis, psoriatic arthritis, Crohn's disease, or another condition approved for risankizumab treatment during the study period
- For risankizumab-exposed group: Must have received at least one dose of risankizumab during pregnancy or within 20 weeks before conception
- For comparison group: Must have received at least one dose of other medications in the same class or line of therapy as risankizumab (such as TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, or other IL-23 inhibitors) during pregnancy or within a specified time before pregnancy based on the medication's half-life
You will not qualify if you...
- For risankizumab-exposed group: Exposure to other medications in the same class or line of therapy as risankizumab during pregnancy or within a specified time before pregnancy based on the medication's half-life
- For risankizumab-exposed group: Pregnancy outcome occurred before enrollment in the registry
- For comparison group: Exposure to risankizumab during pregnancy or within 20 weeks before conception
- For comparison group: Pregnancy outcome occurred before enrollment in the registry
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Evidera, a PPD Business Unit /ID# 238688
Morrisville, North Carolina, United States, 27560-7200
Actively Recruiting
2
PPD Development, LP /ID# 232134
Wilmington, North Carolina, United States, 28401-3331
Completed
Research Team
P
PPD Inc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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