Dexamethasone before infliximab for moderate-to-severe Crohn's disease and ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DISC-0974-201 for adults with IBD-related anemia

  This Phase 2 trial will test whether DISC-0974-201 helps adults with inflammatory bowel disease who have anemia driven by inflammation.

  Recruiting at 15 sites Phase 2 Disc Medicine, Inc · Birmingham, Alabama and 14 other locations · NCT07368972

• Zymfentra (infliximab-dyyb) real-world cohort

  This project will see if Zymfentra (infliximab-dyyb) reduces symptoms over one year in adults with Crohn's disease, ulcerative colitis, or indeterminate colitis who are starting or switching to the drug as part of routine care.

  Recruiting at 11 sites University of North Carolina, Chapel Hill · New Haven, Connecticut and 10 other locations · NCT07237516

• Optimizing Infliximab Treatment for Inflammatory Bowel Disease

  This study is testing a new way to give infliximab to adults with moderate-to-severe inflammatory bowel disease who haven't improved with steroids, to see if personalized dosing can help them feel better.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago · NCT06758024

• Single-dose MT-201 with Infliximab in healthy adults

  This early phase study tests a single dose of MT-201 given with infliximab in healthy adults to see if it is safe and how the body handles it.

  Recruiting Phase 1 Mirador Therapeutics, Inc. · San Diego, California · NCT07776782

• Moderate breathing and movement: Can regular exercise help people with quiescent inflammatory bowel disease feel better?

  This trial tests whether a moderate-intensity exercise program improves quality of life for adults with Crohn's disease or ulcerative colitis who are currently in clinical remission.

  Recruiting Mahidol University · Bangkok Noi, Bangkok · NCT07775794

• ND-12 and H-6 combo for adults with chronic inflammatory diarrhea and ulcerative colitis

  A small randomized study tests whether ND-12 alone or with H-6 helps adults with chronic inflammatory diarrhea related to ulcerative colitis.

  Recruiting Early Phase 1 The Second Hospital of Nanjing Medical University · Nanjing, Jiangsu · NCT07767370

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.