SIIT Based on UST CDST in Patients With CD

Study Overview
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Brief Summary
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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.

Official Title
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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）

Conditions
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Crohn Disease

Intervention / Treatment
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* Biological: selective intensive induction therapy based on ustekinumab clinical decision-making tools


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIIT group<br> | Biological: selective intensive induction therapy based on ustekinumab clinical decision-making tools<br>* 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<br>|
| No Intervention: Non-intensive induction therapy group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |