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Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib (RINVOQ) in Korean Adult Patients With Ulcerative Colitis or Crohn's Disease
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.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
SoonChunHyang University Hospital Cheonan /ID# 270015
Cheonan-si, Chungcheongnam-do, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843
Daejeon, Daejeon Gwang Yeogsi, South Korea
Inje University - Ilsan Paik Hospital /ID# 269995
Goyang-si, Gyeonggido, South Korea
Keimyung University Dongsan Hospital /ID# 269775
Daegu, Gyeongsangbuk-do, South Korea
Chosun University Hospital /ID# 269990
Gwangju, Jeonranamdo, South Korea
Kyung Hee University Hospital /ID# 270003
Dongdaemun-gu, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 268865
Seoul, Seoul Teugbyeolsi, South Korea
Gangnam Severance Hospital /ID# 270020
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014
Seoul, Seoul Teugbyeolsi, South Korea
Hallym University Kangnam Sacred Heart Hospital /ID# 270013
Seoul, Seoul Teugbyeolsi, South Korea
Start Date
June 24, 2024
Primary Completion Date
December 9, 2025
Completion Date
December 9, 2025
Last Updated
January 8, 2026
105
ACTUAL participants
Lead Sponsor
AbbVie
NCT06226883
NCT07271069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06975722