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    Summary
    EudraCT Number:2021-003220-32
    Sponsor's Protocol Code Number:EpicStudy
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003220-32
    A.3Full title of the trial
    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.
    Impatto del monitoraggio terapeutico proattivo precoce sulla durata e l'efficacia della terapia con infliximab nelle malattie infiammatorie croniche intestinali pediatriche: uno studio multicentrico randomizzato-controllato in aperto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Modulation of infliximab therapy based on blood drug levels in pediatric inflammatory bowel disease.
    Modulazione della terapia con infliximab in base ai livelli ematici di farmaco nelle malattie infiammatorie croniche intestinali pediatriche.
    A.3.2Name or abbreviated title of the trial where available
    Proactive therapeutic drug monitoring of infliximab therapy
    Monitoraggio terapeutico proattivo della terapia con infliximab
    A.4.1Sponsor's protocol code numberEpicStudy
    A.5.4Other Identifiers
    Name:EPIC studyNumber:5mille_CT2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIRCCS MATERNO INFANTILE BURLO GAROFOLO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIRCCS BURLO GAROFOLO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Burlo Garofolo
    B.5.2Functional name of contact pointSCR Epidemiologia e Biostatistica
    B.5.3 Address:
    B.5.3.1Street AddressVIA DELL`ISTRIA 65/1
    B.5.3.2Town/ cityTrieste
    B.5.3.3Post code34137
    B.5.3.4CountryItaly
    B.5.4Telephone number+390403785297
    B.5.5Fax number+390403785411
    B.5.6E-mailsegreteria.irb@burlo.trieste.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameinfliximab
    D.3.2Product code [N.A.]
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.2Current sponsor codeinfliximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameinfliximab
    D.3.2Product code [N.A.]
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.2Current sponsor codeInfliximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pediatric Inflammatory Bowel Disease
    Malattie infiammatorie croniche intestinali pediatriche
    E.1.1.1Medical condition in easily understood language
    Pediatric Inflammatory Bowel Disease
    Malattie infiammatorie croniche intestinali pediatriche
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021184
    E.1.2Term IBD
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Valutare l'impatto del monitoraggio terapeutico proattivo introdotto nella fase di induzione (E-pTDM) rispetto allo schema di dosaggio standard dell'infliximab sulla durata e sull'efficacia della terapia durante il primo anno di trattamento.
    E.2.2Secondary objectives of the trial
    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.
    Valutare l'impatto dell'E-pTDM rispetto al dosaggio standard di infliximab su:
    1- concentrazioni ematiche del farmaco
    2- la remissione mucosale a 54 settimane.
    3- la remissione clinical di malattia a 14 settimane
    4-la remissione clinica a biochimica a 14 settimane
    5- la frequenza di sviluppo di anticorpi anti-farmaco (ATI)
    6- la frequenza di reazioni infusionali al farmaco durante il primo anno di trattamento

    Obiettivo aggiuntivo è migliorare le nostre conoscenze sui predittori di risposta alla terapia con infliximab.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    1. Bambini e adolescenti di età compresa tra i 6 e i 17 anni, naïve agli anti-TNF con una diagnosi confermata endoscopicamente di IBD.
    2. Indicazione di iniziare la terapia con infliximab secondo le attuali linee guida per il trattamento delle IBD pediatriche.
    3. Infiammazione attiva supportata da PCR> 5mg/L e/o calprotectina fecale > 150 µg/g prima della prima dose di infliximab
    E.4Principal 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
    1. Ritiro del consenso
    2. Malattia stenosante o penetrante che richiede un intervento chirurgico, ascesso addominale, stenosi sintomatica,
    3. Chirurgia addominale nei 6 mesi precedenti,
    4. Attacco acuto severo di colite definito da PUCAI score > 65
    5. Controindicazione infettiva al trattamento con infliximab (IFX) (test cutaneo positivo alla tubercolina o quantiferon, infezione opportunistica recente, infezione da epatite B, C, virus dell'immunodeficienza),
    6. Precedente esposizione agli anti-TNF,
    7. Esposizione a terapie proibite dal protocollo incluso altri biologici (es. ustekinumab, vedolizumab, abatacept, anakinra..), talidomide, terapia sperimentali.
    8. Gravidanza o allattamento
    E.5 End points
    E.5.1Primary 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.
    L'outcome composito sarà la frequenza di interruzione della terapia con infliximab o la necessità di intensificazione del trattamento per non risposta o perdita di risposta durante il primo anno di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    54 weeks
    54 settimane
    E.5.2Secondary 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.
    1. probabilità cumulativa di interruzione di infliximab
    2. probabilità cumulativa di ricaduta di malattia,
    3. la frequenza di concentrazioni subterapeutiche di infliximab,
    4. la frequenza di anticorpi anti-infliximab (ATI)
    5. la frequenza di reazioni infusionali al farmaco durante il primo anno di trattamento
    6. la frequenza di remissione mucosale a 54 settimane.
    7. frequenza di risposta alla terapia al termine dell'induzione tra le 12 e le 14 settimane.
    8. Remissione clinica a 14 settimane
    9. Remissione clinica e biochimica a 14 settimane

    Endpoint esplorativi
    In un sottogruppo di pazienti saranno determinati i polimorfismi dei singoli nucleotidi su DNA da sangue periferico, lo stato di metilazione del DNA e il profilo di espressione genica dalle cellule epiteliali intestinali prima del trattamento con infliximab e alla 54 settimana e saranno confrontati tra i pazienti che rispondono e non rispondono alla terapia con infliximab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    54 weeks
    54a settimana
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-10-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state86
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 86
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Continuation of therapy as per common clinical practice
    Prosecuzione della terapia come da comune pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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