The Associations of Plasminogen Activator Inhibitor-1 Gene Polymorphisms With Crohn's Disease in Chinese Patients

Completed

• Conditions: Crohn Disease
• Interventions: Biological: Ustekinumab - Standard Dosage

• Registration Number: NCT06935942
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

From January 2020 to January 2025, Crohn's disease (CD) patients and gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. The aim of this research is to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of CD, and to analyze the effects of PAI-1 gene variantions on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.

Detailed Description

From January 2020 to January 2025, a total of 311 CD patients and 495 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of PAI-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of PAI-1 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Multi-model logistic regression was used to explore the effect of PAI-1 gene variation on the clinical response of CD patients in the treatment of UST at week 8.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-13
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 906

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CD patients	Ustekinumab - Standard Dosage	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.

Primary Outcome Measures

Name	Time	Method
the genotypes of PAI-1	Baseline	multiplex polymerase chain reaction-ligase detection reaction technique

Secondary Outcome Measures

Name	Time	Method
clinical response of ustekinumab (UST) treatment	week 8	the changes of Crohn's disease activity index (CDAI)

Trial Locations

Locations (1)

the Second Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China