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

AbbVie

Status: Completed

Conditions: Ulcerative Colitis; Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT06459297

P24-081

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosis with ulcerative colitis or Crohn's Disease suitable for the treatment with Upadacitinib.
• Participants prescribed upadacitinib in accordance with the approved local label.

Exclusion criteria

• Participants with any contraindication to Upadacitinib.
• Participants currently participating in another clinical research not including observational study.

Trial design

105 participants in 1 patient group

Upadacitinib

Description:

Participants will receive upadacitinib as prescribed by their physician according to local label.