Atopic Dermatitis (AD)NCT06503536
A Study to Assess Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Participants Receiving Upadacitinib for Atopic Dermatitis (AD) Through Chart Review
An observational study of Atopic Dermatitis (AD), run by AbbVie at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with Atopic Dermatitis (AD) receiving Upadacitinib undergoing chart review in China
Who may be able to join
- 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
Who cannot join
- Participants who did not fulfill the inclusion criteria will be excluded
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital affiliated to Fudan University /ID# 268259
Shanghai, Shanghai Municipality, 200040
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis (AD), Upadacitinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Upadacitinib | Participants with Atopic Dermatitis (AD) undergo chart review up to180 days after initiating upadacitinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start6 Aug 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503536
- Sponsor's protocol ID
- H24-962
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06503536
- Acronym / sponsor ID
- H24-962
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis (AD), Upadacitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Upadacitinib | – | –Participants with Atopic Dermatitis (AD) undergo chart review up to180 days after initiating upadacitinib. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with Atopic Dermatitis (AD) receiving Upadacitinib undergoing chart review in China
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who did not fulfill the inclusion criteria will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (AD), run by AbbVie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.