SIIT Based on UST CDST in Patients With CD

NCT05861167 | Unknown Phase 4 DMC

• 1 other identifier: 2023ZSLYEC-353
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SIIT group

EXPERIMENTAL

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

Non-intensive induction therapy group

NO INTERVENTION

Interventions

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

SIIT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

SixthSunYetSen

Guangzhou, 省/直辖市, 510655, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sixth Affiliated Hospital, Sun Yat-sen University

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

CN (1)