NCT06126146Completed
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
Source: ClinicalTrials.gov · Last updated 29 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 53 (actual)
- First submitted
- 7 Nov 2023
- Start date
- 26 Oct 2023
- Primary completion date
- 16 May 2024
- Lead sponsor
- AbbVie
- Diseases
- Crohn's disease
- NCT number
- NCT06126146
What you commit to
- Study type: Observational
- Participants enrolled: 53
- From 26 Oct 2023 to the primary completion date, 16 May 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- N/A
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Lothian /ID# 260901 Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| The Royal London Hospital /ID# 259047 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guys and St Thomas NHS Foundation Trust /ID# 258986 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902 Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust /ID# 258989 Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.