Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05139836
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2021-11-29
Brief Title:
A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
Non-Interventional Prospective Observational Cohort Study to Investigate the Effectiveness and Sustained Disease Control of an Upadacitinib Therapy in Moderate to Severe Atopic Dermatitis Patients Over Two Years
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UP-TAINED
Brief Summary:
Atopic dermatitis AD is a skin condition that may cause a rash and itching due to inflammation of the skin Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD This study also aims to understand upadacitinib utilization patterns in real-world clinical practice
Upadacitinib RINVOQ is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany
Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose population and indication The overall duration of the study is approximately 2 years
Participants will attend regular visits per routine clinical practice The effect of the treatment will be checked by medical assessments checking for side effects and questionnaires
Upadacitinib RINVOQ is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany
Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose population and indication The overall duration of the study is approximately 2 years
Participants will attend regular visits per routine clinical practice The effect of the treatment will be checked by medical assessments checking for side effects and questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None