Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT03942120
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2019-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
Sponsor:
Janssen Korea, Ltd., Korea
Organization:
Study Overview
Official Title:
Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA
Status:
COMPLETED
Status Verified Date:
2025-04
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:
STELARA CD PMS
Brief Summary:
The purpose of post-marketing surveillance (PMS) is to assess the safety and effectiveness of ustekinumab (Stelara) for Crohn's disease participants under real world clinical practice.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CNTO1275CRD4029 | OTHER | Janssen Korea, Ltd., Korea | View |