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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-24

Study Completion Date

2025-12-09

Brief Summary

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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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Detailed Description

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Conditions

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Ulcerative Colitis Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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SoonChunHyang University Hospital Cheonan /ID# 270015

Cheonan-si, Chungcheongnam-do, South Korea

Site Status

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

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status

Inje University - Ilsan Paik Hospital /ID# 269995

Goyang-si, Gyeonggido, South Korea

Site Status

Keimyung University Dongsan Hospital /ID# 269775

Daegu, Gyeongsangbuk-do, South Korea

Site Status

Chosun University Hospital /ID# 269990

Gwangju, Jeonranamdo, South Korea

Site Status