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)

Crohn's Disease Clinical Trial

— COMMODUS  

Official title:

Patient-reported Real-world Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in the UK: a Before-and-after Survey of Participants Among Patients That Transition From Maintenance Treatment (360 mg Applied by 4x90 mg PFS) Within the Early Access to Medicine Scheme / Pre-Approval Access Schemes to OBI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126146
• Other study ID #: P24-171
• Status: Recruiting
• Start date: October 26, 2023
• Est. completion date: May 24, 2024

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: UK Medical Operations
• Phone: +447816 180 544
• Email: uk-medops-projects[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 24, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
United Kingdom	NHS Lothian /ID# 260901	Edinburgh
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 258986	London	London, City Of
United Kingdom	The Royal London Hospital /ID# 259047	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902	Newcastle upon Tyne
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 258989	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	Baseline up to approximately 6 months

External Links

•   Related Info