Impact of early proactive therapeutic drug monitoring on the durability and efficacy of infliximab therapy in pediatric inflammatory bowel disease: a multicenter open-label randomized-control trial. - Proactive therapeutic drug monitoring of infliximab therapy

IRCCS MATERNO INFANTILE BURLO GAROFOLO0 个研究点目标入组 86 人开始时间: 2021年10月22日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•Inclusion criteria are:
•1.Anti-TNF naïve children and adolescents, 6-17 years, with a diagnosis of IBD confirmed by a prior endoscopic biopsy that is consistent with the diagnosis
•2.Indication to start anti-TNF therapy in accordance with current guidelines for the treatment of pediatric IBD,
•3.Active inflammation supported by CRP > 5mg/L and /or FC > 150 µg/g before the 1st IFX dose
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Consent withdrawal,
•2.Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture,
•3.Abdominal surgery within the previous 6 months,
•4.Acute severe UC attack defined by a PUCAI score > 65,
•5.Infective contraindication to IFX treatment including positive tuberculin skin test or Quantiferon-TB test, recent opportunistic infection, infection with hepatitis B (HBV), C (HCV), human immunodeficiency virus (HIV),
•6.Previous exposure to anti-TNF;
•7.Exposure to concomitant prohibited medications including other biologics (including but not limited to ustekinumab, vedolizumab, abatacept, anakinra..), thalidomide, investigational drugs
•8.Pregnancy or lactation

发起方

IRCCS MATERNO INFANTILE BURLO GAROFOLO