Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459297
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-11
Brief Title:
Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohns Disease
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib RINVOQ in Korean Adult Patients With Ulcerative Colitis or Crohns Disease
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:
None
Brief Summary:
Ulcerative colitis UC is an idiopathic chronic inflammatory disease affecting the colon Crohns disease CD is an incurable chronic inflammatory disorder of the gastrointestinal tract This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohns disease Adverse events and change in disease activity will be assessed
Upadacitinib is an approved drug for treating Atopic dermatitis AD psoriatic arthritis PsA ankylosing spondylitis AS non-radiographic axial spondyloarthritis nr-axSpA ulcerative colitis UC and Crohns disease CD Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea
Upadacitinib will be administered in accordance with the terms of the local marketing authorization and treatment of participants will be determined solely by the investigator Participants in the study will be followed for up to 52 weeks
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 Atopic dermatitis AD psoriatic arthritis PsA ankylosing spondylitis AS non-radiographic axial spondyloarthritis nr-axSpA ulcerative colitis UC and Crohns disease CD Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea
Upadacitinib will be administered in accordance with the terms of the local marketing authorization and treatment of participants will be determined solely by the investigator Participants in the study will be followed for up to 52 weeks
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