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

Last updated: December 11, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Colic

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT06459297
P24-081
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosis with ulcerative colitis or Crohn's Disease suitable for thetreatment with Upadacitinib.

  • Participants prescribed upadacitinib in accordance with the approved local label.

Exclusion

Exclusion Criteria:

  • Participants with any contraindication to Upadacitinib.

  • Participants currently participating in another clinical research not includingobservational study.

Study Design

Total Participants: 600
Study Start date:
June 24, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • SoonChunHyang University Hospital Cheonan /ID# 270015

    Cheonan-si, Chungcheongnamdo 31151
    Korea, Republic of

    Active - Recruiting

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

    Daejeon, Daejeon Gwang Yeogsi 34943
    Korea, Republic of

    Active - Recruiting

  • Inje University - Ilsan Paik Hospital /ID# 269995

    고양시, Gyeonggido 10380
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Hospital /ID# 269775

    Daegu, Gyeongsangbugdo 42601
    Korea, Republic of

    Active - Recruiting

  • Chosun University Hospital /ID# 269990

    Gwangju, Jeonranamdo 61453
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital /ID# 270003

    Dongdaemun-gu, Seoul Teugbyeolsi 02447
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Medical Centre /ID# 269776

    Seoul, Seoul Teugbyeolsi 07985
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital /ID# 270020

    Seoul, Seoul Teugbyeolsi 06273
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital /ID# 270013

    Seoul, Seoul Teugbyeolsi 07441
    Korea, Republic of

    Active - Recruiting

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

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Health System Severance Hospital /ID# 268865

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital /ID# 270006

    Ulsan, Ulsan Gwang Yeogsi 44033
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center /ID# 269992

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Seoul Songdo Hospital /ID# 270009

    중구, 04597
    Korea, Republic of

    Active - Recruiting

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