Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

Study Identifier
P23-899
CT.gov Identifier
NCT05930275
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
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * A diagnosis of moderate-to-severe crohn's disease (CD). * 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. * Able to understand and communicate with the investigator and comply with the requirements of the study. * Willing to continue with study documentation after cessation of upadacitinib. * Willing and able to participate in the collection of PRO data via a cloud-based application on their personal or provided mobile phone or website app.
    Exclusion Criteria:
    * Any contraindication to upadacitinib. * Previously exposure to upadacitinib in a clinical trial. * Currently participating in interventional research (not including non-interventional study, post-marketing observational study (PMOS) , or registry participation). * Initiation of upadacitinib prior to enrollment.

    Protocol Summary

    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 moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed.

    Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world.

    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. Study visits may be conducted on-site or virtually as per standard of care.

    Study Locations

    Location
    Status
    Location
    Blacktown Hospital /ID# 258574
    Blacktown, New South Wales, Australia, 2148
    Status
    Not applicable
    Location
    Macquarie University Hospital /ID# 268722
    Macquarie University, New South Wales, Australia, 2109
    Status
    Not applicable
    Location
    Mater Misericordiae Limited /ID# 258535
    South Brisbane, Queensland, Australia, 4101
    Status
    Not applicable
    Location
    Ibd Sa /Id# 268335
    Kurralta Park, South Australia, Australia, 5037
    Status
    Not applicable
    Location
    The Queen Elizabeth Hospital /ID# 258536
    Woodville South, South Australia, Australia, 5011
    Status
    Not applicable
    Location
    Monash Health - Monash Medical Centre /ID# 258538
    Clayton, Victoria, Australia, 3168
    Status
    Not applicable
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