Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications

Launched by ABBVIE · Apr 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called risankizumab on pregnancy outcomes. The goal is to compare pregnancies where the mother was treated with risankizumab to those where the mother was treated with other medications. It specifically looks at women with conditions like plaque psoriasis, psoriatic arthritis, and Crohn's disease, which risankizumab is approved to treat. The researchers want to understand how exposure to risankizumab might affect mothers and their babies during and after pregnancy.

To participate, women must be pregnant and residents of the United States. They need to have a diagnosis of one of the specified conditions and either have taken risankizumab during their pregnancy or have used other similar medications. Participants will not receive risankizumab as part of this study but will attend regular check-ups at a hospital or clinic to monitor their health and pregnancy outcomes. The study is currently recruiting participants and aims to gather valuable information that can help inform future treatments for pregnant women with these conditions.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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