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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03936335

  • Recruitment Status

    Recruiting

  • First Posted

    May 3, 2019

  • Last update posted

    October 29, 2020

Study Description

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:Adverse Pregnancy Outcomes
    Atopic Dermatitis
  • Intervention/Treatment: Drug: dupilumab
  • Phase: N/A

Detailed Description

N/A

Study Design

  • 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 2019
  • Estimated Primary Completion Date: July 2027
  • Estimated Study Completion Date: July 2027

Groups and Cohorts

Groups/Cohorts 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.

Outcome Measures

  • 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

Eligibility Criteria

  • Ages Eligible for Study: 18 to 49 Years (Adult)
  • Sexes Eligible for Study: Female
  • 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

Contacts and Locations

Contacts

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

Locations

United States, Massachusetts
Regeneron Research Site
Boston

Sponsors and Collaborators

Regeneron Pharmaceuticals

Sanofi

Investigators

Study Director: Clinical Trial Management Regeneron Pharmaceuticals

More Information

  • Responsible Party: Regeneron Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03936335 History of Changes
  • Other Study ID Numbers: R668-AD-1760
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: October 29, 2020
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Dermatitis, Atopic Dermatitis