Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

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.

NCT Number	NCT07385131
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, First Affiliated Hospital of Wenzhou Medical University, West China Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Huzhou Central Hospital, Taizhou Enze Medical Center Group, Lishui Country People's Hospital, Jinhua People's Hospital, Ningbo Medical Center Lihuili Hospital, Affiliated Wenling Hospital of Wenzhou Medical University, People's Hospital of Quzhou, Taizhou Municipal Center for Disease Control and Prevention, Second Affiliated Hospital of Wenzhou Medical University
Conditions	Inflammatory Bowel Disease (IBD), CD - Crohn's Disease, UC - Ulcerative Colitis
Enrollment	300 participants
Start Date	2025-10-08
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-03