The Association Between TNFSF4 Polymorphism and CD

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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

Key Dates

Start date

Jan 1, 2018

Status verified

Oct 2025

Primary completion

May 31, 2025

Completion

May 31, 2025

Study Design

Enrollment

818 participants (actual)

Arms

• Arm: 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.
• Arm: normal controls
  no biological agents treatment

Primary Outcome Measure

the genotypes of TNFSF4 [ Time Frame: Baseline ]