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| ID | Type | Description | Link |
|---|---|---|---|
| 43838 | Registry Identifier | EU HMA-EMA Catalogue |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations [MCMs], small for gestational age [SGA]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab cohort | Exposed to dupilumab during the relevant exposure window:
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| Other systemic therapy or phototherapy cohort | Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window:
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| Unexposed cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dupilumab | Drug | No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of MCMs | Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through December 2024 | Up to 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of spontaneous abortion or miscarriage | Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024 | Up to 9 months |
| Incidence of stillbirth |
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Key Inclusion Criteria:
Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply
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Adult women with AD who are pregnant between 01 April 2017 and 31 March 2024 (with the start of pregnancy to be defined by the estimated last menstrual period (LMP))
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | Recruiting | Boston | Massachusetts | 02215 | United States |
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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 |
|---|---|
| C582203 | dupilumab |
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Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
| Up to 9 months |
| Incidence of SGA | Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through December 2024 | Up to 21 months |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |