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)

NCT06126146 | Completed

• 1 other identifier: P24-171
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 5

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Risankizumab; Skyrizi

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Risankizumab

Participants will receive risankizumab on-body injector (OBI) as prescribed by their physician according to local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• AbbVie: lead

Study Sites (5)

University Hospital Southampton NHS Foundation Trust /ID# 258989

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust /ID# 258986

London, London, City of, SE1 9RT, United Kingdom

Location

NHS Lothian /ID# 260901

Edinburgh, EH3 9HE, United Kingdom

Location

The Royal London Hospital /ID# 259047

London, E1 1BB, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902

Newcastle upon Tyne, NE3 3HD, United Kingdom

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: October 26, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: June 29, 2025

Record last verified: 2024-05

Locations

GB (5)