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

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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Risankizumab
  • Comparator
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Where

2 sites
Evidera, a PPD Business Unit /ID# 238688
Morrisville, United States
PPD Development, LP /ID# 232134
Wilmington, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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