SIIT Based on UST CDST in Patients With CD

Sun Yat-sen University

Status and phase

Enrolling

Phase 4

Conditions

Crohn Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05861167

2023ZSLYEC-353

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.