Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Polymorphism, Single Nucleotide, Ustekinumab
Conditions
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
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.
Interventions
BIOLOGICALUstekinumab - 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.
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the genotypes of TNFSF4 | Baseline | multiplex polymerase chain reaction-ligase detection reaction technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical response of ustekinumab treatment | week 8 | the changes of the Crohn's disease activity index (CDAI) |
Countries
China
Outcome results
None listed