A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abrocitinib.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 0 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
Overview
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.
Interventions
- Drug Abrocitinib
taken by mouth
Primary outcome measures
- Percent of live birth children with major congenital malformations [Time frame: Enrollment until 12 months after delivery]
Secondary outcome measures (8)
- Percent of participants with children with minor congenital malformations [Time frame: Enrollment until 12 months after delivery]
- Percent of participants with spontaneous abortion [Time frame: Enrollment until end of pregnancy (up to 20 gestational weeks)]
- Percent of participants with stillbirths [Time frame: Enrollment until end of pregnancy (up to 9 months)]
- Percentage of participants with an elective termination [Time frame: Enrollment until end of pregnancy (up to 9 months)]
- Percent of participants with preterm birth [Time frame: Enrollment until 12 months after delivery]
- Percent of participants with children born small for gestational age [Time frame: Enrollment until 12 months after delivery]
- Percentage of participants with children with postnatal growth deficiency [Time frame: Enrollment until 12 months after delivery]
- Percent of participants with infant developmental delay [Time frame: Enrollment until 12 months after delivery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Pfizer — New York
Identifiers
NCT: NCT05721937 · B7451095 · NCT05721937