Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05959083
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-07-17
Brief Title:
Real World Study of Oral Upadacitinib Tablets to Assess Adverse Events and Change in Disease Activity in Adolescent and Adult Chinese Participants With Atopic Dermatitis
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Prospective Multi-center Post-marketing Observational Study to Evaluate the Safety and Effectiveness of Upadacitinib in Chinese Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis AD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Atopic dermatitis AD is a skin condition that may cause a rash and itching due to inflammation of the skin This study will assess how safe and effective upadacitinib is in treating AD in adolescent and adult Chinese participants
Upadacitinib is an approved drug for treating AD Approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in China
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection
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
Upadacitinib is an approved drug for treating AD Approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in China
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection
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
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