NCT07385131

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

Should Routine Prophylactic Dexamethasone Be Administered Before Intravenous Infliximab in Moderate-to-Severe Inflammatory Bowel Disease: A Prospective, Multicenter, Observational Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel disease (IBD). This study is designed to optimize the prophylactic strategy prior to Infliximab treatment and advocate for risk stratification-based individualized prophylaxis regimens to avoid hormonal abuse. Additionally, it will construct a risk score using biomarkers to accurately identify high-risk populations in need of prophylaxis and establish a corresponding predictive model. The study is also intended to reduce the use of unnecessary medications, shorten infusion duration and alleviate the medical burden. It is expected to provide targeted clinical support during the early stage of the disease or the course of treatment, improve the efficacy and precision of individualized treatment for patients, and reduce the physical, psychological and economic burdens caused by ineffective treatment.

Conditions

• Inflammatory Bowel Disease (IBD)
• CD - Crohn's Disease
• UC - Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Dexamethasone (IV)	Before each infusion of infliximab, 5mg of dexamethasone was administered intravenously or an equal volume of normal saline was injected.

Timeline

• Start date: 2025-10-08
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: China