RecruitingNCT04846959

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

Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring


Sponsor

AbbVie

Enrollment

818 participants

Start Date

Jul 30, 2021

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This registry study is tracking pregnancy outcomes in women who were exposed to risankizumab — a biologic medication used for psoriasis, psoriatic arthritis, or Crohn's disease — during pregnancy, to understand whether it is safe for the developing baby. **You may be eligible if:** - You are a US resident who is currently pregnant - You have been diagnosed with a condition for which risankizumab is FDA-approved (such as plaque psoriasis, psoriatic arthritis, or Crohn's disease) - You have received at least one dose of risankizumab during pregnancy or within 20 weeks before conception (for the risankizumab-exposed group) - OR you are pregnant with the same diagnosis and have used a similar biologic medication (for the comparison group) **You may NOT be eligible if:** - Your pregnancy has already ended before you enroll - You are in the risankizumab group but also used another biologic in the same class during pregnancy, or vice versa Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRisankizumab

Subcutaneous Injection

DRUGComparator

Subcutaneous or Intravenous Injection


Locations(2)

Evidera, a PPD Business Unit /ID# 238688

Morrisville, North Carolina, United States

PPD Development, LP /ID# 232134

Wilmington, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT04846959