Clinical trial NCT05959083: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis (AD)
Keywords: Atopic Dermatitis (AD)
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent and adult Chinese participants with atopic dermatitis (AD) who are prescribed Upadacitinib by their physician according to their local label.

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
* Currently participating in any interventional research studies.

Primary outcomes:
measure: Percentage of Participants With Incidence of Serious Infections
timeFrame: Up to approximately 25 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 257722
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University /ID# 257725
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University /ID# 261862
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737
state: Guangdong
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province /ID# 257736
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 257641
state: Liaoning
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xian Jiaotong University /ID# 257733
state: Shaanxi
city: Jinan
country: China
facility: Shandong Dermatological Hospital /ID# 257727
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 256456
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 257726
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital /ID# 257719
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Second Municipal People's Hospital /ID# 257732
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 257720
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital /ID# 261867
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 257723
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: