AD-VISE

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

Brief summary

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.

Observational study

Status:
Recruiting
Conditions:
Atopic Dermatitis
Enrollment:
975 patients
Protocol ID:
P20-441
Observational model:
Cohort
Time perspective:
Prospective

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Eligibility criteria

Participant attributes:
Male and Female

Age:

12 Years and older.

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).

All the cities where the clinical studies are located

St. John's - A1A 4Y3
St. John's - A1C 2H5
Markham - L3P 1X2
Ottawa - K1H 7X3
Richmond Hill - L4C 9M7
Sudbury - P3C 1X8
Whitby - L1N 8M7
Laval - H7N 6L2
Saint-Jerome - J7Z 7E2
Fredericton - E3B 1G9