None listed
Conditions
Interventions
Drug : Of the subjects who provided voluntary consent to participate in the clinical trial and signed the consent form, those who satisfy the inclusion and exclusion criteria will be randomly assigned
12 weeks and =12 weeks following CD diagnosis
? Stratify to 6–17 years and 18–20 years
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactBen Kang
Kyungpook National University Medical Center
Outcome results
None listed