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
A Prospective, Multi-center, Post-marketing, Observational Study to Evaluate the Safety and Effectiveness of Upadacitinib in Chinese Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
1 other identifier
observational
200
1 country
18
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedStudy Start
First participant enrolled
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 16, 2025
July 1, 2025
2.8 years
July 17, 2023
July 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Incidence of Serious Infections
Incidence rate of serious infections in AD participants treated with Upadacitinib will be assessed.
Up to approximately 25 months
Study Arms (1)
Upadacitinib
Adolescent and adult participants will receive upadacitinib as prescribed by their physician irrespective of the study participation.
Eligibility Criteria
Adolescent and adult Chinese participants with atopic dermatitis (AD) who are prescribed Upadacitinib by their physician according to their local label.
You may qualify if:
- 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.
You may not qualify if:
- Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
- Currently participating in any interventional research studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (18)
Peking University Third Hospital /ID# 257722
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital Of Fujian Medical University /ID# 257725
Fuzhou, Fujian, 350005, China
Dermatology Hospital of Southern Medical University /ID# 261862
Guangzhou, Guangdong, 510091, China
The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737
Shenzhen, Guangdong, 518033, China
People's Hospital of Henan Province /ID# 257736
Zhengzhou, Henan, 450003, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724
Wuhan, Hubei, 430022, China
The First Hospital of China Medical University /ID# 257641
Shenyang, Liaoning, 110001, China
Second Affiliated Hospital of Xian Jiaotong University /ID# 257733
Xi'an, Shaanxi, 710004, China
Shandong Dermatological Hospital /ID# 257727
Jinan, Shandong, 250022, China
Huashan Hospital, Fudan University /ID# 256456
Shanghai, Shanghai Municipality, 200040, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 257726
Shanghai, Shanghai Municipality, 200065, China
Shanghai Skin Disease Hospital /ID# 257719
Shanghai, Shanghai Municipality, 200443, China
Chengdu Second Municipal People's Hospital /ID# 257732
Chengdu, Sichuan, 610017, China
West China Hospital, Sichuan University /ID# 257720
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital /ID# 263898
Chengdu, Sichuan, 610072, China
Hangzhou First People's Hospital /ID# 261867
Hangzhou, Zhejiang, 310003, China
The second affiliated hospital of Zhejiang University school of medicine /ID# 257723
Hangzhou, Zhejiang, 310009, China
Ningbo First Hospital /ID# 263884
Ningbo, Zhejiang, 315010, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2023
First Posted
July 25, 2023
Study Start
August 18, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 16, 2025
Record last verified: 2025-07