AI-Powered Research

1) Pediatric patients aged 6–20 years with moderate to severe CD who requires infliximab.
[Patients with Pediatric Crohn’s Disease Activity Index (PCDAI) =30 in the European Crohn’s and Colitis Organisation and European Society of Pediatric Gastroenterology, Hepatology, and Nutrition guidelines.]
2) Pediatric patients without biologic agent administration in previous treatments.
3) Pediatric patients who do not show treatment response or tolerance to corticosteroids, immunomodulators, and primary nutritional therapy, or those for whom these treatments are contraindicated.
4) Pediatric patients whose legal guardians and who themselves provided consent to participation in this study.

Exclusion Criteria

1) Patients with mild CD
2) Patients aged less than 6 years, or 21 years or older
3) Patients with ulcerative colitis
4) Patients with a history of hypersensitivity to humanized protein
5) Patients who require infliximab treatment for anal fissure
6) Patients who are taking corticosteroids (Patients may be included if the steroid dosage is being tapered to halt steroid use.)
7) Patients with a previous history of tuberculosis
8) Patients who have had tuberculosis but have been confirmed to have undergone anti-tuberculosis therapy for the minimum period required by a tuberculosis therapy guideline, and are willing to complete the therapy may be included.
9) Patients who visit a doctor for a medical check-up, and have purified protein derivative (PPD) skin test or interferon-? release assay (IGRA) results within the last 6 months may be included.
10) Patients with chronic type B hepatitis not receiving any treatment
11) Patients who have had human immunodeficiency virus (HIV) infection, or are HIV positive
12) Patients with cardiac diseases of New York Heart Association class III/IV
13) Patients with a history of infection and malignant tumor (excluding basal cell carcinoma or cervical cancer), or with history of small or large intestinal dysplasia in the last 5 years
14) Patients deemed unsuited for participation by the investigator

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The partial mucosal healing rate at 54 weeks of infliximab administration is compared between the TDM-based dosing therapy and the clinical-based dosing therapy groups.

Secondary Outcome Measures

Name	Time	Method
Complete mucosal healing rate and transmural healing rate;Clinical remission rate and sustained clinical remission rate;Biochemical remission: measure CRP and fecal calprotectin levels;Measure the ADA rate;The relationships with mucosal healing, changes in blood levels of biologic agent, and antibody formation;The relationships with concomitant medications, changes in blood levels of biologic agent, and antibody formation