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

Atopic Dermatitis Clinical Trial

— REACH-AD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421740
• Other study ID #: P24-965
• Status: Recruiting
• Start date: June 7, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: Judy Yu
• Email: wenjun.yu[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193	Beijing	Beijing
China	The People's Hospital of Liaoning Province /ID# 268206	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a dose change	Dose change includes: Changed dose, dose escalation or dose tapering.	12 Months
Primary	Number of participants with interruption or permanent discontinuation	Interruption: Upadacitinib is temporarily interrupted due to atopic dermatitis disease condition, economic, tolerance, AE, or personal reasons, and the investigator considers there is still possibility of Upadacitinib re-initiating within the patient's study follow-up period.; Discontinuation: Upadacitinib is permanently discontinued for safety or any other reasons, and the investigator considers Upadacitinib will not be used again, at least within the participant's study follow-up period.	12 Months
Primary	Number of participants with Upadacitinib drug compliance	The participants missed medication, regardless of reason, or incompliance with the prescription as per medical advice are to be recorded in the eDiary, choosing the reason: "Forgot, Self-reduction of medication, interruption because of AE, interruption not due to safety/tolerability, for other reasons".; If no eDiary entries are found within 30 days before the visit, the participant will need to complete the following question in ePRO: timely Upadacitinib intake per medical advice in past 30 days (yes/no); if "no", days-off-drug, intentionally or accidentally, and if "intentionally", reason for incompliance with medical prescription.	12 Months

External Links

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