NCT03411837

Brief Summary

The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

November 13, 2017

Last Update Submit

October 6, 2021

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis, dupilumab

Outcome Measures

Primary Outcomes (3)

  • Quantified Itch Survey

    1 to 3 months

  • Quantified Sleep Survey

    1 to 3 months

  • Quantified Quality of Life Survey

    1 to 3 months

Secondary Outcomes (3)

  • Occurrence of any AEs by 24 months

    24 months

  • Occurrence of any infections by 24 months

    24 months

  • Occurrence of any SAEs by 24 months

    24 months

Study Arms (1)

Dupilumab

Patients with moderated-to-severe atopic dermatitis who are receiving dupilumab as a standard of care

Biological: Dupilumab

Interventions

DupilumabBIOLOGICAL

Biologic (monoclonal antibody)

Also known as: Dupixent
Dupilumab

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with moderate-to-severe atopic dermatitis on dupilumab

You may qualify if:

  • Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
  • Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.

You may not qualify if:

  • Patients not on dupilumab
  • Those who do not comply with the study requirements
  • Those who do not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, MPH

Study Record Dates

First Submitted

November 13, 2017

First Posted

January 26, 2018

Study Start

October 16, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations

US(1)