An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

Study Identifier
P22-921
CT.gov Identifier
NCT05494606
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with a diagnosis of moderate to severe Ulcerative colitis (UC). * Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study. * Participants prescribed upadacitinib in accordance with the approved local label. * Participants able to understand and communicate with the investigator and comply with the requirements of the study. * Participants willing to continue with study documentation after cessation of upadacitinib. * Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).
    Exclusion Criteria:
    * Participants with any contraindication to upadacitinib. * Participants previously exposed to upadacitinib in a clinical trial. * Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).

    Protocol Summary

    Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.

    Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.

    Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

    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
    Gedyt /ID# 249611
    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1115
    Status
    Not applicable
    Location
    Hospital Britanico de Buenos Aires /ID# 249605
    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1280
    Status
    Not applicable
    Location
    Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
    Córdoba, Argentina, 5016
    Status
    Not applicable
    Location
    Blacktown Hospital /ID# 248354
    Blacktown, New South Wales, Australia, 2148
    Status
    Not applicable
    Location
    Nepean Hospital /ID# 248351
    Kingswood, New South Wales, Australia, 2747
    Status
    Not applicable
    Location
    Coral Sea Clinical Research institute /ID# 248352
    North Mackay, Queensland, Australia, 4740
    Status
    Not applicable
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