The Association Between TNFSF4 Polymorphism and CD

The Association Between Tumor Necrosis Factor Superfamily Member 4 Polymorphism and Crohn's Disease

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

Study Overview

• Status: Completed
• Conditions: Polymorphism, Single Nucleotide; Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Ustekinumab
• Intervention / Treatment: Biological: Ustekinumab - Standard Dosage

Detailed Description

From January 2018 to May 2025, a total of 296 CD patients and 532 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of TNFSF4 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of TNFSF4 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Unconditional logistic regression model was used to explore the effect of TNFSF4 gene variation on the clinical response of CD patients in the treatment of UST at week 8 and mucosal healing at week 34, respectively.

• Study Type: Observational
• Enrollment (Actual): 818

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
normal controls; no biological agents treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the genotypes of TNFSF4	multiplex polymerase chain reaction-ligase detection reaction technique	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical response of ustekinumab treatment	the changes of the Crohn's disease activity index (CDAI)	week 8
clinical response of ustekinumab treatment	the changes of the Crohn's disease activity index (CDAI)	week 34

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: SAHoWMU-CR2025-01-227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No