Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117423
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-10-23
Brief Title:
Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Investigating the Safety Feasibility and Optimal Dose of Fluorescently Labeled Adalimumab-680LT for Visualizing Drug Targeting in Inflammatory Bowel Diseases
Status:
RECRUITING
Status Verified Date:
2024-03
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:
GUIDE
Brief Summary:
Crohns Disease CD and Ulcerative Colitis UC are chronic inflammatory bowel diseases IBD Adalimumab is a human monoclonal antibody against TNF-alpha a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors Primary non-response to adalimumab is high in both CD and UC Currently there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated To gain better understanding of the drug targeting of adalimumab in IBD the University Medical Center Groningen UMCG developed fluorescently labeled adalimumab adalimumab-680LT This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging FMI
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508391-11-00 | OTHER | CTIS | None |