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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) - Trial NCT06126146

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.

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NCT06126146
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Trial Details
ClinicalTrials.gov โ€ข NCT06126146
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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

Study Focus

Crohn's Disease

Observational

Sponsor & Location

AbbVie

London, United Kingdom

Timeline & Enrollment

N/A

Oct 26, 2023

Mar 27, 2024

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, unspecified
Other Crohn disease
Crohn disease of large intestine
Crohn disease [regional enteritis]
Crohn disease of small intestine

Data Source

ClinicalTrials.gov

NCT06126146

Non-Device Trial