An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China

Launched by ABBVIE · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the real-world use of a medication called Upadacitinib in people with moderate to severe atopic dermatitis, a skin condition that causes rashes and itching. The trial involves about 1,000 adolescents and adults in China who are already prescribed Upadacitinib by their doctors. Participants will take the medication as directed and will be monitored for about 12 months to understand how well it works and how it fits into their regular treatment.

To join the trial, participants need to be at least 12 years old, weigh at least 40 kg, and have a diagnosis of moderate to severe atopic dermatitis. Importantly, they shouldn’t have taken Upadacitinib before and should be willing to share information about their experiences through surveys. During the study, there won’t be any extra demands on their time; they will simply continue their regular visits to their healthcare provider. This study is a chance for people to contribute to understanding how Upadacitinib works in everyday life for those battling this challenging skin condition.

Gender

ALL

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.

Trial Officials