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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05721937 | Registry Identifier | ClinicalTrials.gov |
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Unexposed to CIBINQO during pregnancy | Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abrocitinib | Drug | taken by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of live birth children with major congenital malformations | 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. | Enrollment until 12 months after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants with children with minor congenital malformations | 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. | Enrollment until 12 months after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Recruiting | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C000634427 | abrocitinib |
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| Percent of participants with spontaneous abortion | An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks. | Enrollment until end of pregnancy (up to 20 gestational weeks) |
| Percent of participants with stillbirths | An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g. | Enrollment until end of pregnancy (up to 9 months) |
| Percentage of participants with an elective termination | 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 | Enrollment until end of pregnancy (up to 9 months) |
| Percent of participants with preterm birth | A live birth occurring at <37 gestational weeks. | Enrollment until 12 months after delivery |
| Percent of participants with children born small for gestational age | Birthweight <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants. | Enrollment until 12 months after delivery |
| Percentage of participants with children with postnatal growth deficiency | Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts | Enrollment until 12 months after delivery |
| Percent of participants with infant developmental delay | Failure to achieve the developmental milestones for chronological age, as defined by the CDC. | Enrollment until 12 months after delivery |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |