Dupilumab Phase 4 Study (DRS)

Northwestern University

Status

Terminated

Conditions

Atopic Dermatitis

Treatments

Biological: Dupilumab

Study type

Observational

Funder types

Other

Identifiers

NCT03411837

STU00088226

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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