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
- Diseases
- Crohn's disease, Ulcerative colitis
- 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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SoonChunHyang University Hospital Cheonan /ID# 270015 Coordinator of this site? Confirm its status | Cheonan-si | South Korea | Unknown status |
| Yeungnam University Medical Center /ID# 269992 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Keimyung University Dongsan Hospital /ID# 269775 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843 Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Kyung Hee University Hospital /ID# 270003 Coordinator of this site? Confirm its status | Dongdaemun-gu | South Korea | Unknown status |
| Inje University - Ilsan Paik Hospital /ID# 269995 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chosun University Hospital /ID# 269990 Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Seoul Songdo Hospital /ID# 270009 Coordinator of this site? Confirm its status | Junggu | South Korea | Unknown status |
| Hallym University Kangnam Sacred Heart Hospital /ID# 270013 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University Health System Severance Hospital /ID# 268865 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital /ID# 270020 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ewha Womans University Medical Centre /ID# 269776 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital /ID# 270006 Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.