SIIT Based on UST CDST in Patients With CD

Phase 4

Recruiting

• Conditions: Crohn Disease
• Interventions: Biological: selective intensive induction therapy based on ustekinumab clinical decision-making tools

• Registration Number: NCT05861167
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

ustekinumab (UST) can effectively induce and maintain clinical remission and mucosal healing of Crohn's disease (CD), but some patients still have poor response. Dose optimization is an effective way to improve the response rate of UST, and re-intravenous induction is a common way of optimization. For patients with secondary loss of response, about half of the patients can re-respond after dose optimization. We plan to use CDST-UST to stratify the response level of patients before treatment, select patients with poor response, and initially give multiple intravenous therapy as an intensive induction therapy strategy, so as to improve the response rate of these patients and achieve individualized treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-06
• Study First Posted: 2023-05-16
• Study Start: 2023-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Diagnosed with CD;
• Active period; Age 18-75 years old;
• UST-CDST scores were used to treat patients with moderate and low responsive activity

Exclusion Criteria

• Subjects had undergone extensive colectomy, subtotal colectomy, or total colectomy; The subject currently has ileostomy and colostomy; Patients with significant liver, kidney, endocrine, respiratory, neurological or cardiovascular diseases; Patients with fibrous stenosis and prestenosis dilatation; Contraindications of UST as documented in other specifications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIIT group	selective intensive induction therapy based on ustekinumab clinical decision-making tools	-

Primary Outcome Measures

Name	Time	Method
Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen	week 24	Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen

Trial Locations

Locations (1)

SixthSunYetSen; 🇨🇳 Guangzhou, China