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

Study Identifier
P24-081
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Ulcerative Colitis (UC)
  • Crohn's Disease (CD)
  • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    19+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    SoonChunHyang University Hospital Cheonan /ID# 270015
    Cheonan-si, Chungcheongnam-do, Republic of Korea, 31151
    Status
    Not applicable
    Location
    The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843
    Daejeon, Daejeon Gwang Yeogsi, Republic of Korea, 34943
    Status
    Not applicable
    Location
    Inje University - Ilsan Paik Hospital /ID# 269995
    Goyang-si, Gyeonggido, Republic of Korea, 10380
    Status
    Not applicable
    Location
    Keimyung University Dongsan Hospital /ID# 269775
    Daegu, Gyeongsangbuk-do, Republic of Korea, 42601
    Status
    Not applicable
    Location
    Chosun University Hospital /ID# 269990
    Gwangju, Jeonranamdo, Republic of Korea, 61453
    Status
    Not applicable
    Location
    Kyung Hee University Hospital /ID# 270003
    Dongdaemun-gu, Seoul Teugbyeolsi, Republic of Korea, 02447
    Status
    Not applicable
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