A Study to Assess Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Participants Receiving Upadacitinib for Atopic Dermatitis (AD) Through Chart Review

November 15, 2024 updated by: AbbVie

REAL-world Patient characterISTICs, Treatment Pattern, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Patients Receiving Upadacitinib for Atopic Dermatitis: A Retrospective Chart Review Study

Atopic Dermatitis (AD) is a common, chronic, and flaring systemic inflammatory skin disorder characterized by intensely pruritic and distressing skin eruptions. This study will assess treatment patterns, treatment outcomes, healthcare resource utilization in Chinese participants receiving Upadacitinib for Atopic Dermatitis (AD) undergoing chart review.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital affiliated to Fudan University /ID# 268259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with Atopic Dermatitis (AD) receiving Upadacitinib undergoing chart review in China

Description

Inclusion Criteria:

  • Participants with at least one primary diagnosis of atopic dermatitis with ICD-10 code of L20.900 [atopic dermatitis, unspecified] or physician-confirmed atopic dermatitis documentation within the study period
  • Participants with at least one documented health record of upadacitinib prescription that has a primary diagnosis of atopic dermatitis within the study period
  • Participants with at least one atopic dermatitis severity measures (i.e., EASI) in the follow-up period including up to 6 months after the index date

Exclusion Criteria:

• Participants who did not fulfill the inclusion criteria will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants Receiving Upadacitinib
Participants with Atopic Dermatitis (AD) undergo chart review up to180 days after initiating upadacitinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who achieve a composite endpoint post-index score of Eczema Area and Severity Index (EASI) < =7
Time Frame: Up to 3 months
Eczema Area and Severity Index (EASI): Clear=0, Almost clear=0.1-1.0, Mild=1.1-7.0, Moderate=7.1-21.0, Severe=21.1-50.0, Very severe=50.1-72.0
Up to 3 months
Number of participants who achieve a composite endpoint post-index score of Investigator's Global Assessment (IGA) × Body Surface Area (BSA) < = 30
Time Frame: Up to 3 months
Investigator's Global Assessment (IGA) × Body Surface Area (BSA): Mild=0-30, Moderate=30.1-130, Severe=130.1-400
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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