Real World Study of Oral Upadacitinib Tablets to Assess Adverse Events and Change in Disease Activity in Adolescent and Adult Chinese Participants With Atopic Dermatitis

AbbVie

Status: Active, not recruiting

Conditions: Atopic Dermatitis (AD)

Study type: Observational

Funder types: Industry

Identifiers

NCT05959083

P21-702

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. This study will assess how safe and effective upadacitinib is in treating AD in adolescent and adult Chinese participants.

Upadacitinib is an approved drug for treating AD. Approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in China.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice

Enrollment: 200 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of moderate to severe atopic dermatitis (AD) at the time of enrollment.
• Chinese adolescents (≥12 to <18 years of age with body weight of ≥40 kg) or adults (≥18 years of age) at the time of enrollment.
• Participants eligible for initiation of Upadacitinib treatment for AD, including any required screening tests indicated per China Label.
• The decision to prescribe Upadacitinib is made prior to and independently of study participation.

Exclusion criteria

• Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
• Currently participating in any interventional research studies.

Trial design

200 participants in 1 patient group

Upadacitinib

Description:

Adolescent and adult participants will receive upadacitinib as prescribed by their physician irrespective of the study participation.