An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China
Overview
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.
Primary outcome measures
- Number of participants with a dose change [Time frame: 12 Months]
- Number of participants with Upadacitinib drug compliance [Time frame: 12 Months]
- Number of participants with interruption or permanent discontinuation [Time frame: 12 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 38 centers
- Beijing Anzhen Hospital /ID# 273443 — Beijing
- China-Japan Friendship Hospital /ID# 274778 — Beijing
- Peking University First Hospital /ID# 274865 — Beijing
- Peking Unversity Third hospital /ID# 274864 — Beijing
- Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193 — Beijing
- The First Affiliated Hospital Of Fujian Medical University /ID# 268210 — Fuzhou
- Changgeng Hospital /ID# 268209 — Xiamen
- Guangzhou Dermatology Hospital /ID# 271684 — Guangzhou
- … and 30 more centers
Identifiers
NCT: NCT06421740 · P24-965