Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring
Overview
- Phase
- Not Applicable
- Intervention
- Risankizumab
- Conditions
- Not specified
- Sponsor
- AbbVie
- Enrollment
- 818
- Locations
- 2
- Primary Endpoint
- Number of Participants with Major Congenital Malformation (MCM)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
Pregnant Women Exposed to Risankizumab
Pregnant women of any age in the United States (US) who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and exposed to risankizumab at any time during pregnancy.
Intervention: Risankizumab
Pregnant Women Not Exposed to Risankizumab
Pregnant women of any age in the US who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and not exposed to risankizumab, but who are exposed to other medications in the same class or line of therapy as risankizumab at any time during pregnancy.
Intervention: Comparator
Outcomes
Primary Outcomes
Number of Participants with Major Congenital Malformation (MCM)
Time Frame: Up to 9 months
MCM is an abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
Secondary Outcomes
- Number of Participants with Stillbirth(Up to 9 months)
- Number of Participants with Minor Congenital Malformation(Up to approximately 2 years (1 year post delivery))
- Number of Participants with Neonatal Death(Up to approximately 10 months (one month post delivery))
- Number of Participants with Spontaneous Abortion (SAB)(Up to 9 months)
- Number of Participants with Infant Developmental Delay(Up to approximately 2 years (1 year post delivery))
- Number of Participants with Postnatal Growth Deficiency(Up to approximately 2 years (1 year post-delivery))
- Number of Participants with Elective Termination of Pregnancy(Up to 9 months)
- Number of Participants with Preterm Birth(Up to 9 months)
- Number of Participants who are Small for Gestational Age (SGA)(Up to 9 months)
- Number of Participants with Serious Infection in the First 6 Months of Life(Up to approximately 2 years (1 year post delivery))