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OpenTrials
Completed

NCT Number: NCT06459297

Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants 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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SoonChunHyang University Hospital Cheonan /ID# 270015, Cheonan-si, Chungcheongnam-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of participants who reported Serious Adverse Event

    Time frame: Up to 52 weeks

    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.

  2. Percentage of participants who reported Serious Adverse Drug Reaction

    Time frame: Up to 52 weeks

    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.

  3. Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction

    Time frame: Up to 52 weeks

    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.

  4. Percentage of participants who reported known (labeled) Adverse Drug Reaction

    Time frame: Up to 52 weeks

    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.

  5. Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction

    Time frame: Up to 52 weeks

    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.

  6. Percentage of participants who reported the events related to important identified risks/important potential risks/missing information

    Time frame: Up to 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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