Actively Recruiting
Should Routine Prophylactic Dexamethasone Be Administered Before Intravenous Infliximab in Moderate-to-Severe Inflammatory Bowel Disease: A Prospective, Multicenter, Observational Cohort Study
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-02-03
300
Participants Needed
1
Research Sites
52 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 research aims to assess whether premedication with dexamethasone before infliximab infusions is necessary for patients with moderate-to-severe inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. The study compares routine prophylactic dexamethasone use to non-routine administration to determine which approach better prevents allergic reactions. It also seeks to develop a risk score using biomarkers to identify patients who truly need prophylaxis, aiming to reduce unnecessary medication use and improve individualized treatment plans. Participants will receive infliximab infusions with two different approaches: one group receives 5 mg of dexamethasone intravenously before each infusion, while the other group does not receive anti-allergic medication if they had no prior infusion reactions. The study observes these methods during the first several infliximab infusions to compare outcomes. This observational design allows researchers to gather data on patient responses without altering standard treatment. Participants will be monitored for allergic infusion reactions up to the fourth infliximab administration, with additional assessments of drug and antibody levels at the fourth and sixth infusions. Researchers will also track severe infusion reactions and hormone-related side effects throughout the study. The total participation time varies, with follow-up continuing through treatment completion. These evaluations aim to support safer and more precise care for patients receiving infliximab therapy.
CONDITIONS
Brief 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 Crohn's disease or ulcerative colitis based on clinical, lab, imaging, endoscopic, and histopathological exams.
- Moderate to severe disease activity defined by CDAI, HBI, PCDAI, Mayo score, or PUCAI depending on age and condition.
- Not currently receiving immunosuppressant therapy and no planned use within the next two months.
- Glucocorticoid dosage at or below 10 tablets with a plan to taper off within two months.
- Planned to receive the first dose of infliximab within the next two weeks.
You will not qualify if you...
- Severe disease requiring biological agent intensification, switch therapy, or surgery within two months.
- History of infusion reactions to biological agents or allergies to drugs like penicillins, cephalosporins, NSAIDs, or contrast media.
- History of food allergy, asthma, or urticaria.
- Chronic daily use of antihistamine antiallergic drugs.
- Relative contraindications to biological agents such as active tuberculosis, recent myocardial infarction, heart failure, or demyelinating diseases.
- Relative contraindications to glucocorticoids including active tuberculosis, severe infections, or gastrointestinal ulcers.
- Current or past cancer including lymphoma or melanoma, or ongoing chemotherapy or radiotherapy.
- Severe complications like massive gastrointestinal bleeding, severe liver or kidney dysfunction, active infections, shock, or severe malabsorption.
- Psychiatric disorders or insufficient education to understand the study.
- Pregnancy or lactation.
- Severe hemodynamic instability or rapidly progressive or end-stage diseases.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the fourth administration of infliximab
Participants receive intravenous infliximab infusions. Before each infusion, they may receive 5mg of dexamethasone intravenously or no premedication depending on previous infusion reactions.
Up to 4 infusion visits
Duration - Until study completion
Participants are monitored for severe infusion reactions and hormone-related side effects through the study completion.
Visits may occur as needed for monitoring
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
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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