None listed
Conditions
Interventions
None listed
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: 1. Male or female patients aged 6 to 18 years with moderate-to-severe Crohn's disease requiring infliximab treatment. o Moderate-to-severe Crohn's disease is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) =30, according to the ECCO and ESPGHAN guidelines. 2. Biologic-naïve patients with no previous exposure to biologic agents. 3. Patients who have had an inadequate response to, are intolerant of, or have a contraindication to conventional therapies, including corticosteroids, immunomodulators, or exclusive enteral nutrition. 4. Written informed consent obtained from the parent(s) or legal guardian(s), and assent from the patient when applicable, prior to study participation.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: 1. Patients who do not require infliximab therapy. 2. Patients younger than 6 years or older than 18 years of age. 3. History of hypersensitivity to infliximab or other humanized protein products. 4. Current systemic corticosteroid therapy, except for patients receiving corticosteroid tapering with the intention of discontinuation. 5. History of tuberculosis (TB). o Patients with a previous history of TB may be enrolled if they have completed the minimum recommended anti-tuberculosis treatment according to current treatment guidelines and are considered by the investigator to have adequately completed therapy. o TB screening may be performed using medical history together with either a tuberculin skin test (PPD) or an interferon-gamma release assay (IGRA). 6. Current or previous chronic hepatitis B or hepatitis C infection. o Patients with screening results of HBsAg negative, HBsAb positive or negative, and HBcAb positive may be enrolled at the investigator's discretion. 7. Known HIV infection or positive HIV test. 8. New York Heart Association (NYHA) Class III or IV heart failure. 9. Active infection, current malignancy (except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix), or a history of colorectal or small intestinal dysplasia within the previous 5 years. 10. Any medical or other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cfDNA fragmentomics-based quantitative tissue injury markers and PD score before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in biochemical scores (CRP and fecal calprotectin);Endoscopic Score;Magnetic Resonance Enteroclysis score;Infliximab Trough level | — |
Countries
Korea, Republic of
Contacts
Public ContactJinhee Seo
Samsung Medical Center
Outcome results
None listed