Clinical trial NCT06421740: An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China
Official title: REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: Upadacitinib
Rinvoq
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: 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.

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.


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.

Primary outcomes:
measure: Number of participants with a dose change
timeFrame: 12 Months
measure: Number of participants with interruption or permanent discontinuation
timeFrame: 12 Months
measure: Number of participants with Upadacitinib drug compliance
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital /ID# 273443
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital /ID# 274778
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital /ID# 274865
state: Beijing
city: Beijing
country: China
facility: Peking Unversity Third hospital /ID# 274864
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University /ID# 268210
state: Fujian
city: Xiamen
country: China
facility: Changgeng Hospital /ID# 268209
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Dermatology Hospital /ID# 271684
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Of Sun Yat-Sen University /ID# 268618
state: Guangdong
city: Hainan
country: China
facility: Hainan Fifth People's Hospital /ID# 269747
state: Hainan
city: Handan
country: China
facility: Hebei Engineering University Affiliated Hospital /ID# 268660
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital Of Harbin Medical University /ID# 270872
state: Heilongjiang
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province /ID# 269744
state: Henan
city: Wuhan
country: China
facility: Wuhan Integrated TCM & Western Medicine Hospital（Wuhan No.1 Hospital) /ID# 272374
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital /ID# 269745
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University /ID# 272373
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 268616
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital Of Nantong University /ID# 269743
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 269742
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College /ID# 268208
state: Jiangsu
city: Dalian
country: China
facility: Dalian Dermatosis Hospital /ID# 272495
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province /ID# 268206
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital /ID# 268661
state: Shandong
city: Jining
country: China
facility: Jining Medical University - Affiliated Hospital /ID# 270873
state: Shandong
city: Weifang
country: China
facility: Weifang People'S Hospital /ID# 268659
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital /ID# 268658
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Of Fudan University /ID# 270277
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People'S Hospital /ID# 268617
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital /ID# 268657
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University /ID# 268313
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital /ID# 268314
state: Sichuan
city: Sichuan
country: China
facility: The Affiliated Hospital Of Southwest Medical University /ID# 268207
state: Sichuan
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region /ID# 269746
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical College /ID# 273451
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of Chinese Medicine /ID# 268613
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No.6 hospital /ID# 268315
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital /ID# 268211
state: Zhejiang
city: Zhuji
country: China
facility: Zhuji People'S Hospital /ID# 268614
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: