The Association Between TNFSF4 Polymorphism and CD

NCT07263464 | Completed FDA Drug

• 1 other identifier: SAHoWMU-CR2025-01-227
• Study Type: observational
• Target: 818
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate the associations between tumor necrosis factor superfamily member 4 (TNFSF4) gene polymorphisms and the risk of Crohn's disease (CD), and to elucidate the impact of TNFSF4 gene variations on the CD clinical phenotype and the efficacy of ustekinumab (UST). The main question it aims to answer is: Does TNFSF4 polymorphism affect susceptibility to CD and the efficacy of UST in CD patients? Participants will have their blood drawn upon enrollment

Conditions

Ustekinumab; Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Polymorphism, Single Nucleotide

Outcome Measures

Primary Outcomes (1)

• the genotypes of TNFSF4

  multiplex polymerase chain reaction-ligase detection reaction technique

  Baseline

Secondary Outcomes (2)

• clinical response of ustekinumab treatment

  week 8

• clinical response of ustekinumab treatment

  week 34

Study Arms (2)

CD patients

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous (SC) dose of 90 mg UST at 8 weeks. Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

Biological: Ustekinumab - Standard Dosage

normal controls

no biological agents treatment

Interventions

Ustekinumab - Standard Dosage BIOLOGICAL

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous dose of 90 mg UST at week 8.Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

CD patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

There was no statistically significant difference in the gender ratio, average age, and proportion of smokers between CD group and normal control group. All study subjects are from the Zhejiang Han population who are not related by blood.

You may qualify if:

• diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

You may not qualify if:

• rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

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

Biospecimen

Retention: SAMPLES WITH DNA

Extract whole genome DNA from peripheral blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

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

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2018
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)