An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT06421740
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with a dose change 12 Months Dose change includes: Changed dose, dose escalation or dose tapering.
Number of participants with interruption or permanent discontinuation 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.Number of participants with Upadacitinib drug compliance 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Beijing Anzhen Hospital /ID# 273443
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital /ID# 274778
🇨🇳Beijing, Beijing, China
Peking University First Hospital /ID# 274865
🇨🇳Beijing, Beijing, China
Peking Unversity Third hospital /ID# 274864
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Of Fujian Medical University /ID# 268210
🇨🇳Fuzhou, Fujian, China
Changgeng Hospital /ID# 268209
🇨🇳Xiamen, Fujian, China
Guangzhou Dermatology Hospital /ID# 271684
🇨🇳Guangzhou, Guangdong, China
The Fifth Affiliated Hospital Of Sun Yat-Sen University /ID# 268618
🇨🇳Zhuhai, Guangdong, China
Hainan Fifth People's Hospital /ID# 269747
🇨🇳Hainan, Hainan, China
Scroll for more (28 remaining)Beijing Anzhen Hospital /ID# 273443🇨🇳Beijing, Beijing, China