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)

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT06126146
• Lead Sponsor: AbbVie

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-26
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Status Verified: 2024-05
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-16
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Individual Item Score in Response to Q18 "Overall, how satisfied are you with your current way of taking your medication (self injection)?" in Post-Injection Self-Injection Assessment Questionnaire (SIAQ)	Baseline up to approximately 6 months	SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed following injections.; Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.

Trial Locations

Locations (5)

Guys and St Thomas NHS Foundation Trust /ID# 258986; 🇬🇧 London, London, City Of, United Kingdom

NHS Lothian /ID# 260901; 🇬🇧 Edinburgh, United Kingdom

The Royal London Hospital /ID# 259047; 🇬🇧 London, United Kingdom

University Hospital Southampton NHS Foundation Trust /ID# 258989; 🇬🇧 Southampton, Hampshire, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902; 🇬🇧 Newcastle upon Tyne, United Kingdom