Status:
COMPLETED
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)
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Brief 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 ri...
Eligibility Criteria
Inclusion
- 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
- N/A
Key Trial Info
Start Date :
October 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06126146
Start Date
October 26 2023
End Date
May 16 2024
Last Update
June 29 2025
Active Locations (5)
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1
University Hospital Southampton NHS Foundation Trust /ID# 258989
Southampton, Hampshire, United Kingdom, SO16 6YD
2
Guys and St Thomas NHS Foundation Trust /ID# 258986
London, London, City of, United Kingdom, SE1 9RT
3
NHS Lothian /ID# 260901
Edinburgh, United Kingdom, EH3 9HE
4
The Royal London Hospital /ID# 259047
London, United Kingdom, E1 1BB