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NCT03411837 Clinical Trial

Dupilumab Phase 4 Study

Atopic Dermatitis Clinical Trial

— DRS  

Official title:
Dupilumab Registry Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03411837
Other study ID # STU00088226
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 16, 2017
Est. completion date August 31, 2019

Study information
Verified date October 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.

Recruitment information / eligibility
Status Terminated
Enrollment 46
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Patients not on dupilumab - Those who do not comply with the study requirements - Those who do not provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Dupilumab
Biologic (monoclonal antibody)

Locations
Country Name City State
United States Northwestern University Department of Dermatology Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantified Itch Survey 1 to 3 months
Primary Quantified Sleep Survey 1 to 3 months
Primary Quantified Quality of Life Survey 1 to 3 months
Secondary Occurrence of any AEs by 24 months Will be determined based off of patient reported safety events 24 months
Secondary Occurrence of any infections by 24 months Will be determined based off of patient reported safety events 24 months
Secondary Occurrence of any SAEs by 24 months Will be determined based off of patient reported safety events 24 months
See also
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