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

AbbVie818 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

818

Conditions

Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment

Interventions

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (2)

Evidera, a PPD Business Unit /ID# 238688

Morrisville, North Carolina, United States

RECRUITING

PPD Development, LP /ID# 232134

Wilmington, North Carolina, United States

COMPLETED

Outcomes

Primary Outcomes

Number of Participants with Major Congenital Malformation (MCM)

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.

Time frame: Up to 9 months

Secondary Outcomes

Number of Participants with Minor Congenital Malformation

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.

Time frame: Up to approximately 2 years (1 year post delivery)

Number of Participants with Stillbirth

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).

Time frame: Up to 9 months

Number of Participants with Spontaneous Abortion (SAB)

Spontaneous abortion is defined as an involuntary fetal loss or expulsion of products of conception occurring at less than 20 gestational weeks.

Time frame: Up to 9 months

Number of Participants with Elective Termination of Pregnancy

Elective termination of pregnancy is defined as an voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively.

Time frame: Up to 9 months

Number of Participants with Preterm Birth

Preterm birth is defined as live birth occurring at less than 37 gestational weeks.

Time frame: Up to 9 months

Number of Participants who are Small for Gestational Age (SGA)

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.

Time frame: Up to 9 months

Number of Participants with Neonatal Death

Neonatal death is defined as death of a live-born infant within 28 days of life.

Time frame: Up to approximately 10 months (one month post delivery)

Number of Participants with Serious Infection in the First 6 Months of Life

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.

Time frame: Up to approximately 2 years (1 year post delivery)

Number of Participants with Postnatal Growth Deficiency

Postnatal growth deficiency is defined as postnatal infant weight less than the 10th percentile for sex and chronological age using standard growth charts.

Time frame: Up to approximately 2 years (1 year post-delivery)

Number of Participants with Infant Developmental Delay

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) .

Time frame: Up to approximately 2 years (1 year post delivery)

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts