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 sites86 target enrollmentOctober 22, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 22, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IRCCS MATERNO INFANTILE BURLO GAROFOLO

•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