Effectiveness of theraPeutic drug mOnitoring (TDM) on mucosal and transmural healing in pediatric patients with moderate to severe luminal CroHn’s disease newly receiving Remsima(infliximab): EPOCH study

Samsung Medical Center0 个研究点目标入组 116 人开始时间: 待定最近更新: 2020年7月13日

适应症

试验速览

暂无简介。

•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.

•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

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