An Observational Study to Evaluate Effectiveness and Safety of Upadacitinib in Chinese Adult Participants With Moderate to Severely Active Ulcerative Colitis (UC)

Study Identifier
P25-085
CT.gov Identifier
NCT06838845
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Chinese participants meet the diagnosis of moderately to severely active Ulcerative colitis (UC) * Participants prescribed upadacitinib at discretion of their treating physicians based on sufficient consideration of benefits/risks for patients per local label * Participant must be an adult (≥ 18 years) * Participant must provide written authorization to use personal and/or health data prior to the entry into the study
    Exclusion Criteria:
    * Participant participating in any interventional trials * Participant with any contraindication to upadacitinib as listed on the local China label * Participant unwilling or unable to comply with the study requirements, including completion of patient reported outcome questionnaires

    Protocol Summary

    Ulcerative colitis (UC) is a chronic, relapsing, and incurable inflammatory disease of the large intestine. The hallmark clinical symptoms include bloody diarrhea associated with rectal urgency and tenesmus.. This study will assess how effective upadacitinib is in treating UC within a Chinese population.

    Upadacitinib is an approved drug for treating UC. Approximately 80 adult participants, who have been prescribed upadacitinib for UC by their physician in accordance with local label, will be enrolled in China.

    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 1 year.

    There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.

    Study Locations

    Location
    Status
    Location
    The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997
    Guangzhou, Guangdong, China, 510080
    Status
    Recruiting
    Location
    The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753
    Guangzhou, Guangdong, China, 510655
    Status
    Recruiting
    Location
    The Second Affiliated Hospital Of Zhengzhou University /ID# 274754
    Zhengzhou, Henan, China, 450014
    Status
    Recruiting