Clinical trial NCT04846959: Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
Official title: Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plaque Psoriasis
Psoriatic Arthritis
Crohn Disease
Other Conditions for Which Risankizumab is an FDA-approved Treatment
Keywords: Pregnancy
Risankizumab
SKYRIZI™
risankizumab-rzaa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2021-04-15
Enrollment: 818
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will comprise 2 cohorts of pregnant women.

* One cohort will include 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 exposed to risankizumab at any time during pregnancy .
* The second cohort will include 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.

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.


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

Primary outcomes:
measure: Number of Participants with Major Congenital Malformation (MCM)
timeFrame: Up to 9 months
Secondary outcomes:
measure: Number of Participants with Minor Congenital Malformation
timeFrame: Up to approximately 2 years (1 year post delivery)
measure: Number of Participants with Stillbirth
timeFrame: Up to 9 months
measure: Number of Participants with Spontaneous Abortion (SAB)
timeFrame: Up to 9 months
measure: Number of Participants with Elective Termination of Pregnancy
timeFrame: Up to 9 months
measure: Number of Participants with Preterm Birth
timeFrame: Up to 9 months
measure: Number of Participants who are Small for Gestational Age (SGA)
timeFrame: Up to 9 months
measure: Number of Participants with Neonatal Death
timeFrame: Up to approximately 10 months (one month post delivery)
measure: Number of Participants with Serious Infection in the First 6 Months of Life
timeFrame: Up to approximately 2 years (1 year post delivery)
measure: Number of Participants with Postnatal Growth Deficiency
timeFrame: Up to approximately 2 years (1 year post-delivery)
measure: Number of Participants with Infant Developmental Delay
timeFrame: Up to approximately 2 years (1 year post delivery)
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Evidera, a PPD Business Unit /ID# 238688
state: North Carolina
city: Wilmington
country: United States
facility: PPD Development, LP /ID# 232134
state: North Carolina
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: