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
- Conditions
- Atopic Dermatitis (AD)
- Registration Number
- NCT05959083
- 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. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
- Currently participating in any interventional research studies.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Incidence of Serious Infections Up to approximately 25 months Incidence rate of serious infections in AD participants treated with Upadacitinib will be assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Huashan Hospital, Fudan University /ID# 256456
🇨🇳Shanghai, Shanghai, China
The second affiliated hospital of Zhejiang University school of medicine /ID# 257723
🇨🇳Hangzhou, Zhejiang, China
Shanghai Skin Disease Hospital /ID# 257719
🇨🇳Shanghai, Shanghai, China
Chengdu Second Municipal People's Hospital /ID# 257732
🇨🇳Chengdu, Sichuan, China
The First Hospital of China Medical University /ID# 257641
🇨🇳Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 257726
🇨🇳Shanghai, Shanghai, China
Peking University Third Hospital /ID# 257722
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Of Fujian Medical University /ID# 257725
🇨🇳Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University /ID# 261862
🇨🇳Guangzhou, Guangdong, China
The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737
🇨🇳Shenzhen, Guangdong, China
People's Hospital of Henan Province /ID# 257736
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724
🇨🇳Wuhan, Hubei, China
Shandong Dermatological Hospital /ID# 257727
🇨🇳Jinan, Shandong, China
West China Hospital, Sichuan University /ID# 257720
🇨🇳Chengdu, Sichuan, China
Second Affiliated Hospital of Xian Jiaotong University /ID# 257733
🇨🇳Xi'an, Shaanxi, China
Hangzhou First People's Hospital /ID# 261867
🇨🇳Hangzhou, Zhejiang, China