Trial Details

Not Recruiting
Basic Information
Clinical ID c5059
Identifier EUCTR2021-003220-32-IT
Trial Title 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 th
Trial URL Visit Original Page
Study Information
Study Results

NULL
Conditions Pediatric Inflammatory Bowel Disease MedDRA version: 20.0.Level: LLT.Classification code 10021184.Term: IBD.System Organ Class: 100000004856.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Product Name: infliximabProduct Code: [N.A.]Pharmaceutical Form: Powder for concentrate for solution for infusionINN or Proposed INN: INFLIXIMABCurrent Sponsor code: infliximabConcentration unit: mg milligram(s)Concentration ty
Participant Information
Sponsor IRCCS MATERNO INFANTILE BURLO GAROFOLO
City NULL
Country/Region Italy
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement NULL
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE4
Time Information
Start Date NULL
Primary Completion Date NULL
Completion Date NULL