A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting (UP-TAINED)

AbbVie

Status: Active, not recruiting

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05139836

P21-705

Details and patient eligibility

About

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice.

Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years.

Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Enrollment: 634 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight >=30 kg at baseline for participants between >=12 and <18 years of age.
• Physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
• Upadacitinib initiated as per the local label. The decision to prescribe upadacitinib must have been made prior to and independently of study participation.
• Medical and medication history available at least for the last 6 months.

Exclusion criteria

- Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).

Trial design

634 participants in 1 patient group

Participants Receiving Upadacitinib

Description:

Participants receiving upadacitinib for moderate to severe atopic dermatitis.