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Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohn's Disease

Ulcerative Colitis Clinical Trial

Official title:
Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib (RINVOQ) in Korean Adult Patients With Ulcerative Colitis or Crohn's Disease

Clinical Trial Summary

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's 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 Crohn's 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 Crohn's 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06459297
Study type Observational
Source AbbVie
Contact KyungJoo Kim
Phone +82-10-3221-0662
Email kyungjoo.kim@abbvie.com
Status Not yet recruiting
Phase
Start date June 30, 2024
Completion date December 31, 2025
View Details
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