The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease

NCT06785493 | Completed

• 1 other identifier: SAHoWMU-CR2025-01-201
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD).

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

Ustekinumab; Individualized treatment; Clinical efficacy; Crohn's disease

Outcome Measures

Primary Outcomes (2)

• The endoscopic efficacy of ustekinumab treatment at week 36

  Simplified Crohn's Disease Endoscopic Score (SES-CD) was employed to evaluate the degree of intestinal inflammation of CD patients.Intestinal inflammation was assessed as mild (3-6 points) , moderate (7-15 points) , and severe (≥16 points) .

  at week 36

• The clinical efficacy of ustekinumab treatment at week 36

  Harvey-Bradshaw Index (HBI) was applied to assess the clinical activity of CD patients.HBI is divided into mild (5-7 points), moderate (8-16 points), and severe (≥ 17 points).

  at week 36

Secondary Outcomes (2)

• influencing factors

  at week 36

• influencing factors

  at week 36

Interventions

Optimized Treatment (OPT) DRUG

After the first sufficient intravenous infusion of UST (6 mg/kg), the patient's response was assessed based on PRO2 at week 8, and an individualized treatment plan was developed. At week 8, the patients with incomplete response of PRO2 (a decline of PRO2 was less than 50% from baseline or still in moderate to severe active phase of PRO2) were given one or more UST intravenous re-induction (6 mg/kg) every 4 or 6 weeks.

Eligibility Criteria

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

Study Population

Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).

You may qualify if:

• Diagnosed with moderate to severe Crohn's disease
• Receiving treatment with ustekinumab

You may not qualify if:

• Combined with other autoimmune diseases (such as systemic lupus erythematosus, Sjogren's syndrome, etc.), malignant tumors, or severe cardiovascular and cerebrovascular diseases
• Merge active tuberculosis or severe infection
• Liver and kidney dysfunction
• Pregnancy or lactation period
• Combination therapy with hormones, immunosuppressants, small molecule drugs, or other biological agents
• Clinical data missing ≥ 30% or lost to follow-up during the follow-up period.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 21, 2025
• Study Start: July 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)