Clinical trial NCT06126146: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Risankizumab
Skyrizi
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who received risankizumab for maintenance treatment of CD through United Kingdom (UK) Early Access to Medicines Scheme (EAMS)/Pre-Approval Access (PAA) schemes who are due to switch from risankizumab pre-filled syringe (PFS) to use of on-body injector (OBI).

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Baseline up to approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 258989
state: Hampshire
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 258986
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 260901
city: London
country: United Kingdom
facility: The Royal London Hospital /ID# 259047
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: