Observing the use of Upadacitinib for treating atopic dermatitis in adolescents and adults in China

REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China

This study looks at how well Upadacitinib works for treating moderate to severe atopic dermatitis in teenagers and adults in China by following around 1000 people over a year as they use the medication in their everyday lives.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: Upadacitinib
• Locations: 38 sites (Beijing, Beijing Municipality and 37 other locations)
• Trial ID: NCT06421740 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the real-world use of Upadacitinib tablets in adolescents and adults diagnosed with moderate to severe atopic dermatitis in China. Approximately 1000 participants will be enrolled across up to 40 sites, receiving Upadacitinib as prescribed by their physicians according to routine clinical practice. Participants will be monitored for about 12 months, attending regular visits without any additional burden. The study focuses on collecting patient-reported data to evaluate treatment outcomes in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates include adolescents aged 12-17 and adults with a clinical diagnosis of moderate to severe atopic dermatitis who are newly prescribed Upadacitinib.

Not a fit: Patients currently participating in interventional research or those who have previously been treated with Upadacitinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Upadacitinib for patients with atopic dermatitis.

How similar studies have performed: Other studies have shown success with similar observational approaches in assessing real-world treatment outcomes, indicating potential for valuable findings in this context.

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.

Where this trial is running

Beijing, Beijing Municipality and 37 other locations

• Beijing Anzhen Hospital /ID# 273443 — Beijing, Beijing Municipality, China (Active_not_recruiting)
• China-Japan Friendship Hospital /ID# 274778 — Beijing, Beijing Municipality, China (Active_not_recruiting)
• Peking University First Hospital /ID# 274865 — Beijing, Beijing Municipality, China (Active_not_recruiting)
• Peking Unversity Third hospital /ID# 274864 — Beijing, Beijing Municipality, China (Active_not_recruiting)
• Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193 — Beijing, Beijing Municipality, China (Active_not_recruiting)
• The First Affiliated Hospital Of Fujian Medical University /ID# 268210 — Fuzhou, Fujian, China (Active_not_recruiting)
• Changgeng Hospital /ID# 268209 — Xiamen, Fujian, China (Active_not_recruiting)
• Guangzhou Dermatology Hospital /ID# 271684 — Guangzhou, Guangdong, China (Active_not_recruiting)
• The Fifth Affiliated Hospital Of Sun Yat-Sen University /ID# 268618 — Zhuhai, Guangdong, China (Active_not_recruiting)
• Hainan Fifth People's Hospital /ID# 269747 — Hainan, Hainan, China (Active_not_recruiting)
• Hebei Engineering University Affiliated Hospital /ID# 268660 — Handan, Hebei, China (Active_not_recruiting)
• The Second Affiliated Hospital Of Harbin Medical University /ID# 270872 — Harbin, Heilongjiang, China (Active_not_recruiting)
• People's Hospital of Henan Province /ID# 269744 — Zhengzhou, Henan, China (Active_not_recruiting)
• Wuhan Integrated TCM & Western Medicine Hospital（Wuhan No.1 Hospital) /ID# 272374 — Wuhan, Hubei, China (Active_not_recruiting)
• Tongji Hospital /ID# 269745 — Wuhan, Hubei, China (Active_not_recruiting)
• Xiangya Hospital Central South University /ID# 272373 — Changsha, Hunan, China (Active_not_recruiting)
• Nanjing Drum Tower Hospital /ID# 268616 — Nanjing, Jiangsu, China (Active_not_recruiting)
• Affiliated Hospital Of Nantong University /ID# 269743 — Nantong, Jiangsu, China (Active_not_recruiting)
• The First Affiliated Hospital of Soochow University /ID# 269742 — Suzhou, Jiangsu, China (Active_not_recruiting)
• The Affiliated Hospital of Xuzhou Medical College /ID# 268208 — Xuzhou, Jiangsu, China (Active_not_recruiting)
• Dalian Dermatosis Hospital /ID# 272495 — Dalian, Liaoning, China (Active_not_recruiting)
• The People's Hospital of Liaoning Province /ID# 268206 — Shenyang, Liaoning, China (Completed)
• Shandong Provincial Hospital /ID# 268661 — Jinan, Shandong, China (Active_not_recruiting)
• Jining Medical University - Affiliated Hospital /ID# 270873 — Jining, Shandong, China (Active_not_recruiting)
• Weifang People'S Hospital /ID# 268659 — Weifang, Shandong, China (Active_not_recruiting)
• Ruijin Hospital /ID# 268658 — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Huashan Hospital Of Fudan University /ID# 270277 — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Shanghai Sixth People'S Hospital /ID# 268617 — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Shanghai Skin Disease Hospital /ID# 268657 — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• West China Hospital of Sichuan University /ID# 268313 — Chengdu, Sichuan, China (Active_not_recruiting)
• Sichuan Provincial People's Hospital /ID# 268314 — Chengdu, Sichuan, China (Recruiting)
• The Affiliated Hospital Of Southwest Medical University /ID# 268207 — Luzhou, Sichuan, China (Active_not_recruiting)
• People's Hospital of Xinjiang Uygur Autonomous Region /ID# 269746 — Ürümqi, Xinjiang, China (Active_not_recruiting)
• The First Affiliated Hospital of Kunming Medical College /ID# 273451 — Kunming, Yunnan, China (Active_not_recruiting)
• Zhejiang Provincial Hospital of Chinese Medicine /ID# 268613 — Hangzhou, Zhejiang, China (Active_not_recruiting)
• Ningbo No.6 hospital /ID# 268315 — Ningbo, Zhejiang, China (Active_not_recruiting)
• Taizhou Central Hospital /ID# 268211 — Taizhou, Zhejiang, China (Active_not_recruiting)
• Zhuji People'S Hospital /ID# 268614 — Zhuji, Zhejiang, China (Active_not_recruiting)

Study contacts

• Study coordinator: Judy Yu

Conditions Atopic Dermatitis; Upadacitinib; Rinvoq