Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| normal controls | no biological agents treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the genotypes of TNFSF4 | multiplex polymerase chain reaction-ligase detection reaction technique | Baseline |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Extract whole genome DNA from peripheral blood
| week 34 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |