Clinical trial • Phase IV • Gastroenterology|Immunology

Infliximab for Inflammatory bowel disease

Phase IV trial of Infliximab for Inflammatory bowel disease.

Overview

Trial Therapeutic Area
Gastroenterology|Immunology
Trial Disease
Inflammatory bowel disease
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
18-09-2024
First CTIS Authorization Date
14-10-2024

Trial design

Randomised, open-label, test arm: infliximab (investigational product) — concentrate for solution for infusion; product record sub02681mig; max total dose listed as 15 mg/kg; product change note: 'administration interval were modified'. comparator arm: infliximab (comparator) — concentrate for solution for infusion; product record sub02681mig; max total dose listed as 10 mg/kg.-controlled Phase IV trial across 10 sites in Italy.

Randomised
Yes
Open Label
Yes
Comparator
Test arm: INFLIXIMAB (investigational product) — concentrate for solution for infusion; product record SUB02681MIG; max total dose listed as 15 mg/kg; product change note: 'Administration interval were modified'. Comparator arm: INFLIXIMAB (comparator) — concentrate for solution for infusion; product record SUB02681MIG; max total dose listed as 10 mg/kg.
Target Sample Size
86
Trial Duration For Participant
365

Eligibility

Recruits 86 paediatric patients.

Pregnancy Exclusion
Pregnancy or lactation (se paragraph 4.4 Pregnancy testing and contraception)
Vulnerable Population
Children and adolescents aged 6-17 years are included; the trial is marked as involving a vulnerable population. Informed consent is required from parent(s)/legal guardian(s). Age-specific subject information sheets and informed consent/assent forms are provided (documents listed: L1_EPIC Study_SIS and ICF 6-11 yr_public; L1_EPIC Study_SIS and ICF 12-17 yr_public; L1_EPIC Study_SIS and ICF Parent_public). Patients unable or unwilling to sign informed consent are excluded.

Inclusion criteria

  • {"criterion_text":"-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\n-Indication to start anti-TNF therapy in accordance with current pediatric guidelines for the treatment of pediatric IBD,\n-Active inflammation supported by CRP > 5mg/L and /or FC > 150 μg/g before the 1st IFX dose"}

Exclusion criteria

  • {"criterion_text":"-Patients who are not able or willing to sign informed consent\n-Pregnancy or lactation (se paragraph 4.4 Pregnancy testing and contraception)\n-Current cancer\n-Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture,\n-Abdominal surgery within the previous 6 months,\n-Acute severe UC attack defined by a PUCAI score ³ 65,\n-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),\n-Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients,\n-Moderate or severe heart failure (NYHA class III/IV),\n-Previous exposure to anti-TNF;\n-Exposure to concomitant prohibited medications including other biologics (including but not limited to ustekinumab, vedolizumab, abatacept, anakinra..), thalidomide, investigational drugs"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The primary composite endpoint is the frequency of IFX discontinuation, due to treatment failure or adverse events, or need for treatment intensification due to non-response or LOR during the first year of treatment.","definition_or_measurement_approach":"Composite measure of the frequency (proportion) of infliximab (IFX) discontinuation for treatment failure or adverse events, or requirement for treatment intensification because of non-response or loss of response (LOR) assessed during the first year of treatment."}

Secondary endpoints

  • {"endpoint_text":"-The cumulative probability of IFX discontinuation\n-The cumulative probability of LOR\n-Subtherapeutic IFX concentrations,\n-Occurrence of ATI\n-Occurrence of infusion reactions\n-Endoscopic remission at 54 weeks\n-Treatment response at the end of induction between 12-14 weeks\n-Clinical remission at week 14\n-Clinical and biochemical remission at week 14","definition_or_measurement_approach":"Endpoints are event- or outcome-based as stated: cumulative probabilities (time-to-event) for IFX discontinuation and LOR; measurement of IFX concentrations to identify subtherapeutic levels; occurrence/frequency of anti-TNF inhibitors (ATI) and infusion reactions; endoscopic remission assessed at 54 weeks; clinical response/remission assessed at end of induction (12-14 weeks) and at week 14; clinical and biochemical remission assessed at week 14. Specific assessment scales/times beyond the stated timepoints are not detailed in the provided record."}

Recruitment

Planned Sample Size
86
Recruitment Window Months
45
Consent Approach
Informed consent is required from parent(s)/legal guardian(s). Age-specific subject information sheets and informed consent/assent forms are available for children aged 6-11 and 12-17, and a parent information/consent form is provided (document titles: L1_EPIC Study_SIS and ICF 6-11 yr_public; L1_EPIC Study_SIS and ICF 12-17 yr_public; L1_EPIC Study_SIS and ICF Parent_public). The record excludes patients unable or unwilling to sign informed consent. Languages of the consent documents are not specified in the provided record.

Geography

Total Number Of Sites
10
Total Number Of Participants
86

Italy

Earliest CTIS Part Ii Submission Date
07-10-2024
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
168
Number Of Sites
10
Number Of Participants
86

Sites

Site Name
Casa Sollievo Della Sofferenza
Department Name
U.O.C. di Pediatria
Principal Investigator Name
Antonio Marseglia
Principal Investigator Email
a.marseglia@operapadrepio.it
Contact Person Name
Antonio Marseglia
Contact Person Email
a.marseglia@operapadrepio.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Gastroenterologia ed Epatologia Pediatrica
Principal Investigator Name
Salvatore Oliva
Principal Investigator Email
salvatore.oliva@uniroma1.it
Contact Person Name
Salvatore Oliva
Contact Person Email
salvatore.oliva@uniroma1.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Clinica Pediatrica, Unità di gastroenterologia, endoscopia e nutrizione clinica
Principal Investigator Name
Sara Lega
Principal Investigator Email
sara.lega@burlo.trieste.it
Contact Person Name
Sara Lega
Contact Person Email
sara.lega@burlo.trieste.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Pediatria
Principal Investigator Name
Roberto Panceri
Principal Investigator Email
roberto.panceri@irccs-sangerardo.it
Contact Person Name
Roberto Panceri
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Gastroenterologia pediatrica ed endoscopia digestiva
Principal Investigator Name
Serena Arrigo
Principal Investigator Email
serenaarrigo@gaslini.org
Contact Person Name
Serena Arrigo
Contact Person Email
serenaarrigo@gaslini.org
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
SOC Gastroenterologia e Nutrizione
Principal Investigator Name
Paolo Lionetti
Principal Investigator Email
paolo.lionetti@unifi.it
Contact Person Name
Paolo Lionetti
Contact Person Email
paolo.lionetti@unifi.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
U.O.S.D. Gastroenterologia Pediatrica e Fibrosi Cistica
Principal Investigator Name
Claudio Romano
Principal Investigator Email
claudio.romano@unime.it
Contact Person Name
Claudio Romano
Contact Person Email
claudio.romano@unime.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Pediatria
Principal Investigator Name
Stefano Martelossi
Principal Investigator Email
stefano.martelossi@aulss2.veneto.it
Contact Person Name
Stefano Martelossi
Site Name
ASST Papa Giovanni XXIII
Department Name
Pediatric Department
Principal Investigator Name
Naire Sansotta
Principal Investigator Email
nsansotta@asst-pg23.it
Contact Person Name
Naire Sansotta
Contact Person Email
nsansotta@asst-pg23.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
Gastroenterologia Pediatrica
Principal Investigator Name
Patrizia Alvisi
Principal Investigator Email
patrizia.alvisi@ausl.bologna.it
Contact Person Name
Patrizia Alvisi

Sponsor

Primary sponsor

Full Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
INFLIXIMAB
Active Substance
Infliximab
Modality
Monoclonal antibody
Routes Of Administration
CONCENTRATE FOR SOLUTION FOR INFUSION
Route
CONCENTRATE FOR SOLUTION FOR INFUSION
Authorisation Status
EU product record SUB02681MIG (marketing authorisation number not provided)
Dose Levels
Max total dose 15 mg/kg (dose unit mg/kg); productChangeDescription: 'Administration interval were modified'
Maximum Dose
15 mg/kg
Investigational Product Name
INFLIXIMAB
Active Substance
Infliximab
Modality
Monoclonal antibody
Routes Of Administration
CONCENTRATE FOR SOLUTION FOR INFUSION
Route
CONCENTRATE FOR SOLUTION FOR INFUSION
Authorisation Status
EU product record SUB02681MIG (marketing authorisation number not provided)
Dose Levels
Max total dose 10 mg/kg (dose unit mg/kg)
Maximum Dose
10 mg/kg

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