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

Recruiting

• Conditions: Other Conditions for Which Risankizumab is an FDA-approved Treatment; Plaque Psoriasis; Crohn Disease; Psoriatic Arthritis
• Interventions: Drug: Risankizumab; Drug: Comparator

• Registration Number: NCT04846959
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-15
• Study Start: 2021-07-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2033-01-01
• Study Completion: 2033-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 818

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).

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women Exposed to Risankizumab	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.
Pregnant Women Not Exposed to Risankizumab	Comparator	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Major Congenital Malformation (MCM)	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 Outcome Measures

Name	Time	Method
Number of Participants with Preterm Birth	Up to 9 months	Preterm birth is defined as live birth occurring at less than 37 gestational weeks.
Number of Participants with Stillbirth	Up to 9 months	Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at 20 gestational weeks or greater (\>=20 gestational weeks), or, if gestational age is unknown, a fetus weighing 350 g or more (\>=350 g).
Number of Participants with Minor Congenital Malformation	Up to approximately 2 years (1 year post delivery)	Minor Congenital Malformation is an anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Number of Participants with Neonatal Death	Up to approximately 10 months (one month post delivery)	Neonatal death is defined as death of a live-born infant within 28 days of life.
Number of Participants with Spontaneous Abortion (SAB)	Up to 9 months	Spontaneous abortion is defined as an involuntary fetal loss or expulsion of products of conception occurring at less than 20 gestational weeks.
Number of Participants with Infant Developmental Delay	Up to approximately 2 years (1 year post delivery)	Infant developmental delay is defined as failure to achieve the developmental milestones for chronological age, as defined by the Center for Disease Control and Prevention (CDC) .
Number of Participants with Postnatal Growth Deficiency	Up to approximately 2 years (1 year post-delivery)	Postnatal growth deficiency is defined as postnatal infant weight less than the 10th percentile for sex and chronological age using standard growth charts.
Number of Participants with Elective Termination of Pregnancy	Up to 9 months	Elective termination of pregnancy is defined as an voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively.
Number of Participants who are Small for Gestational Age (SGA)	Up to 9 months	SGA is defined as Birth weight less than the 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.
Number of Participants with Serious Infection in the First 6 Months of Life	Up to approximately 2 years (1 year post delivery)	Serious infection is defined as an infection that occurs within an infant's first 6 months of life and results in significant disability, incapacity, or death, is life-threatening, requires inpatient or prolonged hospitalization, or is considered medically important.

Trial Locations

Locations (2)

Evidera, a PPD Business Unit /ID# 238688; 🇺🇸 Morrisville, North Carolina, United States

PPD Development, LP /ID# 232134; 🇺🇸 Wilmington, North Carolina, United States