Evaluating pregnancy outcomes in women exposed to risankizumab
Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring
This study looks at how pregnancy outcomes differ for women with conditions like psoriasis and Crohn's disease who have used risankizumab compared to those who haven't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 818 (estimated) |
| Sex | Female |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | Risankizumab |
| Locations | 2 sites (Morrisville, North Carolina and 1 other locations) |
| Trial ID | NCT04846959 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to compare pregnancy outcomes between women exposed to risankizumab and those not exposed, focusing on conditions like plaque psoriasis, psoriatic arthritis, and Crohn's disease. Approximately 818 pregnant women will be enrolled, with half having been treated with risankizumab and the other half receiving different treatments. The study will track maternal, fetal, and infant outcomes during pregnancy and up to one year post-delivery. Participants will not receive risankizumab as part of this study.
Who should consider this trial
Good fit: Ideal candidates include pregnant women diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions treated with risankizumab.
Not a fit: Patients who are not currently pregnant or those who have not been treated with risankizumab or comparable medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and outcomes of pregnancies exposed to risankizumab, guiding treatment decisions for pregnant women with these conditions.
How similar studies have performed: While similar studies have been conducted, this specific comparison of risankizumab-exposed pregnancies is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Morrisville, North Carolina and 1 other locations
- Evidera, a PPD Business Unit /ID# 238688 — Morrisville, North Carolina, United States (Recruiting)
- PPD Development, LP /ID# 232134 — Wilmington, North Carolina, United States (Completed)
Study contacts
- Study coordinator: PPD Inc
- Email: glowpregnancyregistry@ppd.com
- Phone: 1-877-302-2161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.