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NCT06459297Completed

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

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

Source: ClinicalTrials.gov · Last updated 8 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
105 (actual)
First submitted
11 Jun 2024
Start date
24 Jun 2024
Primary completion date
9 Dec 2025
Lead sponsor
AbbVie
NCT number
NCT06459297

What you commit to

  • Study type: Observational
  • Participants enrolled: 105
  • From 24 Jun 2024 to the primary completion date, 9 Dec 2025
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SoonChunHyang University Hospital Cheonan /ID# 270015
Coordinator of this site? Confirm its status
Cheonan-siSouth KoreaUnknown status
Yeungnam University Medical Center /ID# 269992
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DaeguSouth KoreaUnknown status
Keimyung University Dongsan Hospital /ID# 269775
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DaeguSouth KoreaUnknown status
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843
Coordinator of this site? Confirm its status
DaejeonSouth KoreaUnknown status
Kyung Hee University Hospital /ID# 270003
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Dongdaemun-guSouth KoreaUnknown status
Inje University - Ilsan Paik Hospital /ID# 269995
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaUnknown status
Chosun University Hospital /ID# 269990
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GwangjuSouth KoreaUnknown status
Seoul Songdo Hospital /ID# 270009
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JungguSouth KoreaUnknown status
Hallym University Kangnam Sacred Heart Hospital /ID# 270013
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SeoulSouth KoreaUnknown status
Yonsei University Health System Severance Hospital /ID# 268865
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SeoulSouth KoreaUnknown status
Gangnam Severance Hospital /ID# 270020
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014
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SeoulSouth KoreaUnknown status
Ewha Womans University Medical Centre /ID# 269776
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SeoulSouth KoreaUnknown status
Ulsan University Hospital /ID# 270006
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UlsanSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.