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
AbbVie·ClinicalTrials.govRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Crohn's Disease
Study type
Observational
Sponsor & location
Primary sponsor
AbbVie
Location
London, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Oct 26, 2023
End date
Mar 27, 2024
Enrollment
80 participants
Primary outcome

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)

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.

ICD-10 classifications
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06126146
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06126146 through Pure Global AI's free database. This phase not specified trial is sponsored by AbbVie and is currently Recruiting. The study focuses on Crohn's Disease. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.