Dexamethasone before infliximab for moderate-to-severe Crohn's disease and ulcerative colitis
Should Routine Prophylactic Dexamethasone Be Administered Before Intravenous Infliximab in Moderate-to-Severe Inflammatory Bowel Disease: A Prospective, Multicenter, Observational Cohort Study
This project will test whether giving an IV dose of dexamethasone before infliximab infusions prevents allergic reactions in people aged 14–80 with moderate-to-severe Crohn's disease or ulcerative colitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | infliximab, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07385131 on ClinicalTrials.gov |
What this trial studies
This comparative observational cohort study enrolls patients with moderate-to-severe IBD receiving intravenous infliximab and compares routine prophylactic dexamethasone use to non-routine, risk-stratified administration. Clinical outcomes, infusion reaction events, infusion duration, steroid exposure, and biomarker data will be collected to build a risk score and predictive model for targeted prophylaxis. Investigators will compare rates of infusion reactions, overall steroid use, and healthcare utilization between the groups. The multicenter effort is led by the Second Affiliated Hospital, School of Medicine, Zhejiang University, with collaborators aiming to shorten infusion visits and reduce unnecessary steroid use through individualized prophylaxis.
Who should consider this trial
Good fit: People aged 14–80 with a confirmed diagnosis of moderate-to-severe Crohn's disease or ulcerative colitis who are scheduled to receive intravenous infliximab are the intended candidates.
Not a fit: Patients with low predicted risk of infusion reactions or with contraindications to corticosteroids are less likely to receive benefit from this prophylaxis strategy.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary steroid exposure, lower infusion-reaction rates among high-risk patients, and shorten infusion visits.
How similar studies have performed: Premedication with corticosteroids or antihistamines has been used in practice and reported in observational studies with mixed results, so routine steroid prophylaxis is not definitively established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 14 to 80 years. * Confirmed cases of inflammatory bowel disease (IBD) with a definitive diagnosis of Crohn's disease (CD) or ulcerative colitis (UC), based on the diagnostic criteria specified in the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) and the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (Xi'an, 2023). The diagnosis shall be made by comprehensive analysis of clinical manifestations, laboratory tests, imaging examinations, endoscopic examinations and histopathological findings, with infectious colitis and other non-infectious colitis ruled out. * Moderate to severe CD: for adults aged 18 years and above, baseline Crohn's Disease Activity Index (CDAI) score \>220 or Harvey-Bradshaw Index (HBI) score ≥5; for adolescents aged 14 to 17 years, baseline Pediatric Crohn's Disease Activity Index (PCDAI) score ≥31. Or moderate to severe UC: for adults aged 18 years and above, baseline Mayo score ≥6; for adolescents aged 14 to 17 years, baseline Pediatric Ulcerative Colitis Activity Index (PUCAI) score ≥36. * Not receiving immunosuppressant therapy (e.g., azathioprine) at present, with no plan to add such medications within the next two months. * Current glucocorticoid dosage ≤ 10 tablets, and a definite plan has been made for tapering down the dosage to complete discontinuation within the next two months. * Planned to receive the first dose of infliximab within the next two weeks. Exclusion Criteria: * Patients with severe disease who, as judged by the attending clinician, require biological agent intensification therapy, switch therapy or elective surgery within 2 months, such as those with obvious stenosis, perforation, fistula and other conditions leading to obstruction, hemorrhage, infection, etc. * Patients at high risk of infusion reactions, including those with a history of any biological agent-related infusion reactions, or a history of allergy to any drugs such as penicillins, cephalosporins, sulfonamides, non-steroidal anti-inflammatory drugs (NSAIDs), contrast media, etc. * Patients with a definite history of food allergy, as well as a past history of asthma or urticaria. * Patients on chronic daily use of antihistamine antiallergic drugs such as loratadine, cetirizine, diphenhydramine, chlorpheniramine maleate tablets, terfenadine, etc. * Patients with relative contraindications to biological agents, such as active tuberculosis with positive chest X-ray, strongly positive purified protein derivative (PPD) skin test or positive T-SPOT test; a history of myocardial infarction, heart failure or demyelinating neurological diseases in the past 5 years, etc. * Patients with relative contraindications to glucocorticoids, such as active tuberculosis, severe infection, gastrointestinal ulcer, etc. * Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy. * Patients complicated with massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, intractable vomiting, severe malabsorption syndrome, etc. * Patients with psychiatric disorders or insufficient educational level to fully understand the study content. * Pregnant or lactating patients. * Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yan Chen
- Email: chenyan72_72@zju.edu.cn
- Phone: 86+13757118653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.