Psoriasis Clinical Trial
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
Summary
Psoriasis is a skin disorder wherein skin cells multiply faster than normal, making the skin itchy and look patchy and red. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. The main objective of this study is to assess maternal, fetal, and infant outcomes of women who are exposed to risankizumab during pregnancy with those in an unexposed comparator population.
Risankizumab is an approved drug for the treatment of Plaque Psoriasis. 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 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
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There are 2 Locations for this study
Morrisville North Carolina, 27560, United States
Wilmington North Carolina, 28401, United States
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