NCT06503536

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

August 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

July 10, 2024

Last Update Submit

November 15, 2024

Conditions

Keywords

Atopic Dermatitis (AD)Upadacitinib

Outcome Measures

Primary Outcomes (2)

  • Number of participants who achieve a composite endpoint post-index score of Eczema Area and Severity Index (EASI) < =7

    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

    Investigator's Global Assessment (IGA) × Body Surface Area (BSA): Mild=0-30, Moderate=30.1-130, Severe=130.1-400

    Up to 3 months

Study Arms (1)

Participants Receiving Upadacitinib

Participants with Atopic Dermatitis (AD) undergo chart review up to180 days after initiating upadacitinib.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital affiliated to Fudan University /ID# 268259

Shanghai, Shanghai Municipality, 200040, China

Location

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

August 6, 2024

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations