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

Status: Recruiting
Location: See all (14) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
SoonChunHyang University Hospital Cheonan /ID# 270015
RECRUITING
Cheonan-si
Keimyung University Dongsan Hospital /ID# 269775
RECRUITING
Daegu
Yeungnam University Medical Center /ID# 269992
RECRUITING
Daegu
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843
RECRUITING
Daejeon
Kyung Hee University Hospital /ID# 270003
RECRUITING
Dongdaemun-gu
Inje University - Ilsan Paik Hospital /ID# 269995
RECRUITING
Goyang-si
Chosun University Hospital /ID# 269990
RECRUITING
Gwangju
Seoul Songdo Hospital /ID# 270009
RECRUITING
Junggu
Ewha Womans University Medical Centre /ID# 269776
RECRUITING
Seoul
Gangnam Severance Hospital /ID# 270020
RECRUITING
Seoul
Hallym University Kangnam Sacred Heart Hospital /ID# 270013
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 268865
RECRUITING
Seoul
Ulsan University Hospital /ID# 270006
RECRUITING
Ulsan
Contact Information
Primary
KyungJoo Kim
kyungjoo.kim@abbvie.com
+82-10-3221-0662
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2025-12
Participants
Target number of participants: 600
Treatments
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov