An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in Adult Participants in the United Kingdom (UK)

Study Identifier
P24-171
CT.gov Identifier
NCT06126146
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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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:
    * Aged 18 years or older * Eligible for and received risankizumab for maintenance treatment of Crohn's Disease (CD) through United Kingdom (UK) Early Access to Medicines Scheme (EAMS)/Pre-Approval Access (PAA) schemes * The decision to treat with risankizumab was made independently, in line with usual clinical practice, marketing authorisation and prior to enrolment in the study * Exits UK EAMS/PAA and switches from risankizumab pre-filled syringe (PFS) to on-body injector (OBI) * Can physically self-administer risankizumab OBI without carer assistance * Can read and understand English * Willing and able to provide voluntary informed consent * Able and willing to participate in this study.
    Exclusion Criteria:
    N/A

    Protocol Summary

    Crohn's Disease (CD) is a chronic condition that causes inflammation of the gastrointestinal tract or gut. This study will assess real-world, adult participant experience of self-injection with the risankizumab OBI.

    Risankizumab is an approved drug for the treatment of CD in adults. Approximately 80 participants who are prescribed risankizumab by their doctors and are transitioning from the pre-filled syringe (PFS) to the use of OBI will be enrolled in this study in the United Kingdom (UK).

    Participants will receive risankizumab OBI as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 6 months.

    There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site, at home, or virtually as per standard of care.

    Study Locations

    Location
    Status
    Location
    University Hospital Southampton NHS Foundation Trust /ID# 258989
    Southampton, Hampshire, United Kingdom, SO16 6YD
    Status
    Not applicable
    Location
    Guys and St Thomas NHS Foundation Trust /ID# 258986
    London, London, City Of, United Kingdom, SE1 9RT
    Status
    Not applicable
    Location
    NHS Lothian /ID# 260901
    Edinburgh, United Kingdom, EH3 9HE
    Status
    Not applicable
    Location
    The Royal London Hospital /ID# 259047
    London, United Kingdom, E1 1BB
    Status
    Not applicable
    Location
    The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902
    Newcastle upon Tyne, United Kingdom, NE3 3HD
    Status
    Not applicable