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

Crohn Disease Clinical Trial

Official title:

Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846959
• Other study ID #: P20-036
• Status: Recruiting
• Start date: July 30, 2021
• Est. completion date: January 1, 2033

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: PPD Inc
• Phone: 1-877-302-2161
• Email: glowpregnancyregistry[@]ppd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 818
• Est. completion date: January 1, 2033
• Est. primary completion date: January 1, 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Crohn Disease
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis

Intervention

Drug:
• Risankizumab
Subcutaneous Injection
• Comparator
Subcutaneous or Intravenous Injection

Locations

Country	Name	City	State
United States	Evidera, a PPD Business Unit /ID# 238688	Morrisville	North Carolina
United States	PPD Development, LP /ID# 232134	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 9 months
Secondary	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.	Up to approximately 2 years (1 year post delivery)
Secondary	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).	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	Number of Participants with Preterm Birth	Preterm birth is defined as live birth occurring at less than 37 gestational weeks.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	Number of Participants with Neonatal Death	Neonatal death is defined as death of a live-born infant within 28 days of life.	Up to approximately 10 months (one month post delivery)
Secondary	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.	Up to approximately 2 years (1 year post delivery)
Secondary	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.	Up to approximately 2 years (1 year post-delivery)
Secondary	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) .	Up to approximately 2 years (1 year post delivery)

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