Trial Details

Not Recruiting
Basic Information
Clinical ID c2352
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 therapy
Trial URL Visit Original Page
Study Information
Study Results

No results available
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: infliximab Product Code: [N.A.] Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB Current Sponsor code: infliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Product Name: infliximab Product Code: [N.A.] Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB Current Sponsor code: Infliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Participant Information
Sponsor IRCCS MATERNO INFANTILE BURLO GAROFOLO
City -
Country/Region Italy
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -