Clinical trial NCT05721937: A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
Official title: CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: pregnancy
dermatitis, atopic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2023-02-10
Enrollment: 400
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include pregnant women of any age who meet the eligibility criteria for inclusion. The exposed cohort will include women who are exposed to CIBINQO at any time during pregnancy. All pregnant women exposed to CIBINQO will be eligible to participate in the registry, but the analysis population will be limited to women with moderate-to-severe AD. The primary comparator group will include women with moderate to- severe AD who are unexposed to CIBINQO during pregnancy.

Brief summary: The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring.

The study is seeking participants who:

* Are currently or recently pregnant
* Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis

All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy.

The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy.

Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.


Eligibility criteria: Inclusion Criteria:

* Women of any age who are currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
* Consent to participate in this study and evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
* Authorization for her healthcare provider(s) to provide data to the registry
* Must receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception) OR have a diagnosis of moderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.

Exclusion Criteria:

* Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.

Primary outcomes:
measure: Percent of live birth children with major congenital malformations
timeFrame: Enrollment until 12 months after delivery
Secondary outcomes:
measure: Percent of participants with children with minor congenital malformations
timeFrame: Enrollment until 12 months after delivery
measure: Percent of participants with spontaneous abortion
timeFrame: Enrollment until end of pregnancy (up to 20 gestational weeks)
measure: Percent of participants with stillbirths
timeFrame: Enrollment until end of pregnancy (up to 9 months)
measure: Percentage of participants with an elective termination
timeFrame: Enrollment until end of pregnancy (up to 9 months)
measure: Percent of participants with preterm birth
timeFrame: Enrollment until 12 months after delivery
measure: Percent of participants with children born small for gestational age
timeFrame: Enrollment until 12 months after delivery
measure: Percentage of participants with children with postnatal growth deficiency
timeFrame: Enrollment until 12 months after delivery
measure: Percent of participants with infant developmental delay
timeFrame: Enrollment until 12 months after delivery
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: