Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126146
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2023-11-07
Brief Title:
An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector OBI for the Treatment of Crohns Disease in Adult Participants in the United Kingdom UK
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
Patient-reported Real-world Experience of Risankizumab On-body Injector OBI for the Treatment of Crohns 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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMMODUS
Brief Summary:
Crohns 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None