A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
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|ClinicalTrials.gov Identifier: NCT05721937|
Recruitment Status : Not yet recruiting
First Posted : February 10, 2023
Last Update Posted : June 1, 2023
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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.
|Condition or disease||Intervention/treatment|
|Atopic Dermatitis||Drug: Abrocitinib|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring|
|Estimated Study Start Date :||May 31, 2023|
|Estimated Primary Completion Date :||December 31, 2027|
|Estimated Study Completion Date :||December 31, 2027|
Exposed to CIBINQO during pregnancy
Received at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception).
taken by mouth
Unexposed to CIBINQO during pregnancy
Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy.
- Percent of live birth children with major congenital malformations [ Time Frame: Enrollment until 12 months after delivery ]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.
- Percent of participants with children with minor congenital malformations [ Time Frame: Enrollment until 12 months after delivery ]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.
- Percent of participants with spontaneous abortion [ Time Frame: Enrollment until end of pregnancy (up to 20 gestational weeks) ]An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.
- Percent of participants with stillbirths [ Time Frame: Enrollment until end of pregnancy (up to 9 months) ]An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
- Percentage of participants with an elective termination [ Time Frame: Enrollment until end of pregnancy (up to 9 months) ]A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to fetal abnormalities
- Percent of participants with preterm birth [ Time Frame: Enrollment until 12 months after delivery ]A live birth occurring at <37 gestational weeks.
- Percent of participants with children born small for gestational age [ Time Frame: Enrollment until 12 months after delivery ]Birthweight <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
- Percentage of participants with children with postnatal growth deficiency [ Time Frame: Enrollment until 12 months after delivery ]Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts
- Percent of participants with infant developmental delay [ Time Frame: Enrollment until 12 months after delivery ]Failure to achieve the developmental milestones for chronological age, as defined by the CDC.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||0 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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.
- Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05721937
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||February 10, 2023 Key Record Dates|
|Last Update Posted:||June 1, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.|
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