Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408935
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-07
Brief Title:
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohns Disease Patients
Sponsor:
Janssen-Cilag Ltd
Organization:
Janssen-Cilag Ltd
Study Overview
Official Title:
A Phase 3b Open-label Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohns Disease Patients
Status:
RECRUITING
Status Verified Date:
2024-10
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:
REASON
Brief Summary:
The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract transmural healing with the help of a score called Magnetic Resonance Index of Activity MaRIA based on a scan at Week 48
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2023-504040-34-00 | REGISTRY | None | None |
| CNTO1959CRD3008 | OTHER | None | None |
| 2023-504040-34 | EUDRACT_NUMBER | Janssen Cilag Ltd | None |