A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis (AD-VISE)

AbbVie

Status: Active, not recruiting

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05081557

P20-441

Details and patient eligibility

About

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants >=12 years old in the real-world setting.

Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide.

Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Enrollment: 873 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician confirmed diagnosis of atopic dermatitis (AD) or atopic eczema at baseline.
• Symptom onset >=1-year prior to baseline.
• Initiation of upadacitinib treatment for AD is indicated and prescribed per local label.
• The decision to prescribe UPA is made prior to and independently of study participation.
• Medical and medication history available for previous 6 months.
• Participants who can understand the questionnaires, with parental support as required for adolescents.
• Participants who are able to understand and communicate with the investigator and comply with the requirements of the study.
• Participants who are willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., tablet).
• Participants who are willing and able to complete the patient-reported questionnaires.

Exclusion criteria

• Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).

Trial design

873 participants in 1 patient group

Participants Receiving Upadacitinib

Description:

Participants receiving upadacitinib for atopic dermatitis.