The Association Between TNFSF4 Polymorphism and CD

Second Affiliated Hospital of Wenzhou Medical University

Status: Completed

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

Treatments: Biological: Ustekinumab - Standard Dosage

Study type: Observational

Funder types: Other

Identifiers

NCT07263464

SAHoWMU-CR2025-01-227

Details and patient eligibility

About

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

Full 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.

Enrollment: 818 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

818 participants in 2 patient groups

CD patients

Description:

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.

Treatment:

Biological: Ustekinumab - Standard Dosage

normal controls

Description:

no biological agents treatment