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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• South Korea
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center /ID# 269992
  • Junggu, South Korea, 04597
    • Seoul Songdo Hospital /ID# 270009
  • Chungcheongnam-do
    • Cheonan-si, Chungcheongnam-do, South Korea, 31151
      • SoonChunHyang University Hospital Cheonan /ID# 270015
  • Daejeon Gwang Yeogsi
    • Daejeon, Daejeon Gwang Yeogsi, South Korea, 34943
      • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843
  • Gyeonggido
    • Goyang-si, Gyeonggido, South Korea, 10380
      • Inje University - Ilsan Paik Hospital /ID# 269995
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, South Korea, 42601
      • Keimyung University Dongsan Hospital /ID# 269775
  • Jeonranamdo
    • Gwangju, Jeonranamdo, South Korea, 61453
      • Chosun University Hospital /ID# 269990
  • Seoul Teugbyeolsi
    • Dongdaemun-gu, Seoul Teugbyeolsi, South Korea, 02447
      • Kyung Hee University Hospital /ID# 270003
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Yonsei University Health System Severance Hospital /ID# 268865
    • Seoul, Seoul Teugbyeolsi, South Korea, 06273
      • Gangnam Severance Hospital /ID# 270020
    • Seoul, Seoul Teugbyeolsi, South Korea, 06591
      • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014
    • Seoul, Seoul Teugbyeolsi, South Korea, 07441
      • Hallym University Kangnam Sacred Heart Hospital /ID# 270013
    • Seoul, Seoul Teugbyeolsi, South Korea, 07985
      • Ewha Womans University Medical Centre /ID# 269776
  • Ulsan Gwang Yeogsi
    • Ulsan, Ulsan Gwang Yeogsi, South Korea, 44033
      • Ulsan University Hospital /ID# 270006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with ulcerative colitis or Crohn's Disease

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Upadacitinib; Participants will receive upadacitinib as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who reported Serious Adverse Event	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to 52 weeks
Percentage of participants who reported Serious Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Percentage of participants who reported known (labeled) Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Percentage of participants who reported the events related to important identified risks/important potential risks/missing information	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Upadacitinib; Ulcerative colitis; Crohn's Disease; Inflammatory Bowel Diseases; RINVOQ
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: P24-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No