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Completed

NCT Number: NCT07263464

The Association Between TNFSF4 Polymorphism and CD

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

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Key information

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Polymorphism, Single Nucleotide Ustekinumab

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. the genotypes of TNFSF4

    Time frame: Baseline

    multiplex polymerase chain reaction-ligase detection reaction technique

Secondary outcomes

  1. clinical response of ustekinumab treatment

    Time frame: week 8

    the changes of the Crohn's disease activity index (CDAI)

  2. clinical response of ustekinumab treatment

    Time frame: week 34

    the changes of the Crohn's disease activity index (CDAI)

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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