An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

Study Identifier
P22-920
CT.gov Identifier
NCT05841537
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
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with a diagnosis of Crohn's disease (CD) confirmed by clinical, endoscopic and/or histological indices. * Participants initiating risankizumab at the clinician's discretion as part of their routine clinical care. * Participants prescribed risankizumab 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 and able to provide authorization to use and disclose personal health information. * Participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone).
    Exclusion Criteria:
    * Females who are pregnant or breast feeding at baseline. * Participants with any contraindication to risankizumab. * Participants previously exposed to risankizumab. * Participants currently participating in an interventional clinical trial.

    Protocol Summary

    Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.

    Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide.

    Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months.

    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
    Universitaetsklinikum St. Poelten /ID# 258828
    Sankt Pölten, Lower Austria, Austria, 3100
    Status
    Not applicable
    Location
    Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824
    Vienna, State of Vienna, Austria, 1060
    Status
    Not applicable
    Location
    Medizinische Universitaet Wien /ID# 261472
    Vienna, State of Vienna, Austria, 1090
    Status
    Not applicable
    Location
    Medizinische Universitaet Graz /ID# 253559
    Graz, Styria, Austria, 8010
    Status
    Not applicable
    Location
    Medizinische Universitaet Innsbruck /ID# 253563
    Innsbruck, Tyrol, Austria, 6020
    Status
    Not applicable
    Location
    Klinikum Wels-Grieskirchen GmbH /ID# 253558
    Wels, Upper Austria, Austria, 4600
    Status
    Not applicable
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