An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin.

Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China.

Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months.

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital /ID# 273443, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescents (body weight >= 40 kg at the Baseline Visit for patients between >= 12 and < 18 years of age) and adults at the time of enrollment.
Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC.
The decision to prescribe UPA is made prior to and independent of study participation.
The participant should not be treated with UPA prior to this study.
Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps.
The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted.

Exclusion criteria

The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation).
Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.

Treatment and study plan

Primary outcomes

Number of participants with a dose change

Time frame: 12 Months

Dose change includes: Changed dose, dose escalation or dose tapering.
Number of participants with Upadacitinib drug compliance

Time frame: 12 Months

The participants missed medication, regardless of reason, or incompliance with the prescription as per medical advice are to be recorded in the eDiary, choosing the reason: "Forgot, Self-reduction of medication, interruption because of AE, interruption not due to safety/tolerability, for other reasons".

If no eDiary entries are found within 30 days before the visit, the participant will need to complete the following question in ePRO: timely Upadacitinib intake per medical advice in past 30 days (yes/no); if "no", days-off-drug, intentionally or accidentally, and if "intentionally", reason for incompliance with medical prescription.
Number of participants with interruption or permanent discontinuation

Time frame: 12 Months

Interruption: Upadacitinib is temporarily interrupted due to atopic dermatitis disease condition, economic, tolerance, AE, or personal reasons, and the investigator considers there is still possibility of Upadacitinib re-initiating within the patient's study follow-up period.

Discontinuation: Upadacitinib is permanently discontinued for safety or any other reasons, and the investigator considers Upadacitinib will not be used again, at least within the participant's study follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Judy Yu

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China

Acronym: REACH-AD

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: May 20, 2024
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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