SIIT Based on UST CDST in Patients With CD

Crohn Disease Clinical Trial

Official title:

Efficacy and Safety of Selective Intensive Induction Therapy Based on Ustekinumab Clinical Decision-making Tools in Patients With Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study（SIIT-CD Study）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861167
• Other study ID #: 2023ZSLYEC-353
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Biological:
• selective intensive induction therapy based on ustekinumab clinical decision-making tools
At week 0 and week 8, UST was induced intravenously twice (stratified according to body weight, see instructions for dosage), and at the third time, intravenous or standard subcutaneous injection regimen was used according to CRP standard

Locations

Country	Name	City	State
China	SixthSunYetSen	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen	Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen	week 24