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

NCT06459297 | Completed

• 1 other identifier: P24-081
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Inflammatory Bowel Diseases; Upadacitinib; RINVOQ; Ulcerative colitis; Crohn's Disease

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with ulcerative colitis or Crohn's Disease

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (14)

SoonChunHyang University Hospital Cheonan /ID# 270015

Cheonan-si, Chungcheongnam-do, 31151, South Korea

Location

The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843

Daejeon, Daejeon Gwang Yeogsi, 34943, South Korea

Location

Inje University - Ilsan Paik Hospital /ID# 269995

Goyang-si, Gyeonggido, 10380, South Korea

Location

Keimyung University Dongsan Hospital /ID# 269775

Daegu, Gyeongsangbuk-do, 42601, South Korea

Location

Chosun University Hospital /ID# 269990

Gwangju, Jeonranamdo, 61453, South Korea

Location

Kyung Hee University Hospital /ID# 270003

Dongdaemun-gu, Seoul Teugbyeolsi, 02447, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 268865

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Gangnam Severance Hospital /ID# 270020

Seoul, Seoul Teugbyeolsi, 06273, South Korea

Location

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 270013

Seoul, Seoul Teugbyeolsi, 07441, South Korea

Location

Ewha Womans University Medical Centre /ID# 269776

Seoul, Seoul Teugbyeolsi, 07985, South Korea

Location

Ulsan University Hospital /ID# 270006

Ulsan, Ulsan Gwang Yeogsi, 44033, South Korea

Location

Yeungnam University Medical Center /ID# 269992

Daegu, 42415, South Korea

Location

Seoul Songdo Hospital /ID# 270009

Junggu, 04597, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 24, 2024
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

KR (14)