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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Participants will receive risankizumab on-body injector (OBI) as prescribed by their physician according to local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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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).
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust /ID# 258989 | Southampton | Hampshire | SO16 6YD | United Kingdom | ||
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| Guys and St Thomas NHS Foundation Trust /ID# 258986 |
| London |
| London, City of |
| SE1 9RT |
| United Kingdom |
| NHS Lothian /ID# 260901 | Edinburgh | EH3 9HE | United Kingdom |
| The Royal London Hospital /ID# 259047 | London | E1 1BB | United Kingdom |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902 | Newcastle upon Tyne | NE3 3HD | United Kingdom |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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