Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT06785493
Status:
COMPLETED
Last Update Posted:
2025-01-21
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease
Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Organization:
Study Overview
Official Title:
A Retrospective Analysis on the Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Patients With Crohn's Disease
Status:
COMPLETED
Status Verified Date:
2025-01
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:
None
Brief Summary:
The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD).
Detailed Description:
Interleukin (IL-12) and interleukin (IL-23) co-contain the P40 subunit, and ustekinumab (UST) is a fully humanized IgG1 monoclonal antibody that targets the P40 subunit. The conventional regimen of UST in the treatment of Crohn's disease is that after the first sufficient dose (6 mg/kg) of intravenous infusion, 90 mg UST is injected subcutaneously at the 8th week according to the patient's response, and maintenance therapy is given every 8 or 12 weeks. However, data from real-world studies suggest that the clinical efficacy of treating CD with the conventional UST regimen is less than ideal.Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab in patients with Crohn's disease .
Study Oversight
Has Oversight DMC:
False
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?: