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)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2023-10-26
• Primary completion: 2024-05-16
• Completion: 2024-05-16
• First posted: 2023-11-13
• Last updated: 2025-06-29

Locations

5 sites across 1 country: United Kingdom