Pediatric Inflammatory Bowel Disease MedDRA version: 20.0 Level: LLT Classification code 10021184 Term: IBD System Organ Class: 100000004856
Conditions
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:
Sponsors
IRCCS MATERNO INFANTILE BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact of a proactive therapeutic drug monitoring strategy introduced as early as the induction phase (E-pTDM) compared to the standard infliximab dosing schedule on infliximab durability and efficacy during the first year of treatment.;Secondary Objective: 1- To evaluate the efficacy of E-pTDM in reducing the frequency of subtherapeutic IFX concentrations, 2- To evaluate the efficacy of E-pTDM on endoscopic healing at 54 week 3- To evaluate the efficacy of E-pTDM on clinical remission at week 14, 4- To evaluate the efficacy of E-pTDM on clinical and biochemical remission at week 14 5- To evaluate the efficacy of E-pTDM in reducing the frequency of ATI, 6- To evaluate the efficacy of E-pTDM in reducing the frequency of infusion reactions, Additional objective -To improve the current knowledge on biomarkers predictive of anti-TNF response and failure.;Primary end point(s): The primary composite endpoint is the frequency of IFX discontinuation or need for treatment intensification due to non-response or loss of response during the first year of treatment.;Timepoint(s) of evaluation of this end point: 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The cumulative probability of IFX discontinuation 2. The cumulative probability of LOR 3. Subtherapeutic IFX concentrations, 4. Occurrence of ATI 5. Occurrence of infusion reactions 6. Endoscopic remission at 54 weeks 7. Treatment response at the end of induction between 12-14 weeks 8. Clinical remission at week 14 9. Clinical and biochemical remission at week 14 Exploratory endpoints Single Nucleotide Polimorfism (SNPs) from peripheral blood, DNA methylation and transcription profiling from IECs, will be analyzed to identify genetic and epigenetic patterns that predict response or failure to IFX.;Timepoint(s) of evaluation of this end point: 54 weeks | — |
Countries
Italy
Contacts
Public ContactSCR Epidemiologia e Biostatistica
IRCCS Burlo Garofolo
Outcome results
None listed