SIIT Based on UST CDST in Patients With CD

NCT ID: NCT05861167

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-06-01

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIIT group

Group Type: EXPERIMENTAL

selective intensive induction therapy based on ustekinumab clinical decision-making tools

Intervention Type: BIOLOGICAL

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

Non-intensive induction therapy group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiang Gao

Sixth Affiliated Hospital, Sun Yat-sen University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SixthSunYetSen

Guangzhou, 省/直辖市, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jun Hu

Role: primary

hujun33@mail.sysu.edu.cn

13535452363

Other Identifiers

2023ZSLYEC-353

Identifier Type: -

Identifier Source: org_study_id