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Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936335
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of 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.

Condition or disease Intervention/treatment
Adverse Pregnancy Outcomes Atopic Dermatitis Drug: dupilumab

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Study Type : Observational
Estimated Enrollment : 3930 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : July 21, 2027
Estimated Study Completion Date : July 21, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab

Group/Cohort Intervention/treatment
Dupilumab cohort

Exposed to dupilumab during the relevant exposure window:

  • First trimester
  • Pregnancy
Drug: dupilumab
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.
Other Names:
  • REGN668
  • Dupixent®
  • SAR23189

Other systemic therapy or phototherapy cohort

Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window:

  • First trimester
  • Pregnancy
Unexposed cohort
  • Not exposed to systemic medications (including dupilumab) or phototherapy; and
  • Received topical prescription therapy, or a second diagnosis for AD on a date that differs from the base population qualifying AD diagnosis date during the relevant exposure window:
  • First trimester
  • Pregnancy



Primary Outcome Measures :
  1. Incidence of major congenital malformations [ Time Frame: Up to 21 months ]
    Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through 31 July 2023


Secondary Outcome Measures :
  1. Incidence of spontaneous abortion or miscarriage [ Time Frame: Up to 9 months ]
    Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024

  2. Incidence of stillbirth [ Time Frame: Up to 9 months ]
    Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024

  3. Incidence of small for gestational age [ Time Frame: Up to 21 months ]
    Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through 31 July 2023



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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))
Criteria

Key Inclusion Criteria:

  • Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP
  • Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy

Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply


Information from the National Library of Medicine

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): NCT03936335


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Massachusetts
Regeneron Research Site Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03936335    
Other Study ID Numbers: R668-AD-1760
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases