Actively Recruiting
Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-02-03
300
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
T
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 14 to 80 years.
- Confirmed diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) based on clinical, laboratory, imaging, endoscopic, and histopathological tests.
- Moderate to severe Crohn's disease: adults with Crohn's Disease Activity Index >220 or Harvey-Bradshaw Index ≥5; adolescents aged 14-17 with Pediatric Crohn's Disease Activity Index ≥31.
- Moderate to severe ulcerative colitis: adults with Mayo score ≥6; adolescents aged 14-17 with Pediatric Ulcerative Colitis Activity Index ≥36.
- Not currently receiving immunosuppressant therapy and no plan to start within 2 months.
- Current glucocorticoid dose ≤10 tablets with a plan to taper off within 2 months.
- Planned to receive first infliximab dose within 2 weeks.
You will not qualify if you...
- Severe disease requiring biological agent intensification, switch therapy, or surgery within 2 months (e.g., stenosis, perforation, fistula causing obstruction, hemorrhage, infection).
- History of infusion reactions to biological agents or allergy to penicillins, cephalosporins, sulfonamides, NSAIDs, contrast media, etc.
- Definite history of food allergy, asthma, or urticaria.
- Chronic daily use of antihistamine antiallergic drugs.
- Relative contraindications to biological agents (active tuberculosis, positive PPD or T-SPOT, recent myocardial infarction, heart failure, demyelinating neurological diseases).
- Relative contraindications to glucocorticoids (active tuberculosis, severe infection, gastrointestinal ulcer).
- Current solid tumors, history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.
- Complications such as massive gastrointestinal hemorrhage, severe liver or kidney dysfunction, active infections, shock, intractable vomiting, severe malabsorption.
- Psychiatric disorders or insufficient education to understand the study.
- Pregnant or lactating patients.
- Severe hemodynamic instability or rapidly progressive/end-stage diseases.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yan Chen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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