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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7264   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-002648-35
    Sponsor's Protocol Code Number:ProRAPID
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-002648-35
    A.3Full title of the trial
    Prospective Analysis of Pharmacokinetic Infliximab Data in pediatric CD
    patients
    Prospectieve analyse van pharmacokinetiek van Inflximiab data in
    kinderen met inflammatoire darmziekten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective Analysis of Pharmacokinetic Infliximab Data in pediatric CD
    patients
    Prospectieve analyse van pharmacokinetiek van Inflximiab data in
    kinderen met inflammatoire darmziekten
    A.3.2Name or abbreviated title of the trial where available
    PRO-RAPID
    PRO-RAPID
    A.4.1Sponsor's protocol code numberProRAPID
    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 SponsorErasmus Medical Center
    B.1.3.4CountryNetherlands
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.6E-maill.deridder@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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.3.11 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Crohn's disease
    Ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    Ziekte van Crohn
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study objective of our study is to assess the efficacy of an
    IFX intensified induction scheme vs. a standard dosing schedule in
    improving drug exposure (=therapeutic trough levels) without treatment
    escalation in pediatric CD patients.
    Het doel van de PRO-RAPID (Prospectieve Analyse Pharmacokinetiek
    Inflammatoire Darmziekten) studie is om te onderzoeken of een
    intensiever infliximabbehandelschema leidt tot betere uitkomsten van de
    ziekte.
    E.2.2Secondary objectives of the trial
    • Proportion of patients with IFX TL ≥ 5 μg/mL at week 24 without the
    need for treatment escalation
    • Clinical and biochemical remission at weeks 4, 12, and 24 without the
    need for treatment escalation in patients with TL ≥ 5 μg/mL and in
    patients with TL < 5 μg/mL
    • Predictors of IFX TLs at weeks 4, 12, and 24. Factors included in this
    analysis will be sex, age, body mass index (BMI), wPCDAI, IBD
    laboratory values, ATI, dose, and interval of IFX infusions
    • Development of ATI until week 24
    • Prediction of patients who will respond vs. those who will not despite
    adequate TLs at weeks 12 and 24 based on proteomics analysis by
    OLINK
    • Evaluation of quality of life at baseline, weeks 4, 12, and 24 in all
    patients
    • Adverse event rate over time
    • Percentage patienten met IFX spiegels ≥ 5 μg/mL op week 24 zonder
    behandelintensificatie.
    • Klinische en biochemische remissie op week 4, 12 en 24 zonder
    behandelintensificatie bij patienten met IFX spiegel≥ 5 μg/m en
    patienten met IFX spiegel < 5 μg/mL.
    • Voorspellende factoren van IFX spiegels op week 4, 12 en 24.
    Covariaten die worden meegenomen in deze analyse zijn geslacht,
    XML File Identifier: PcjOirbzROKqle83AVOY7ncmP7o=
    Page 10/20
    leeftijd, body mass index (BM), wPCDAI, IBD lab, antistoffen tegen
    infliximab and dosering en interval van infliximab infusen.
    • Ontwikkeling van antistoffen tegen infliximab tot en met week 24.
    • Onderzoek naar voorspellende eiwitten (gebaseerd op OLINK analyse)
    op patienten die reageren vs niet reageren op behandeling met inflximab
    ondanks adequate infliximab spiegels
    • Kwaliteit van leven op baseline, week 12 en
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Anti-TNF-α naïve children (age 1-15 years) with CD and an indication to
    start IFX treatment will be eligible for inclusion after a diagnosis of CD is
    made based on the Porto criteria [11]. Indications of starting IFX
    treatment as per ECCO-ESPGHAN guidelines include non-response after
    induction with exclusive enteral nutrition or steroids, non-response to
    immunomodulators, severe growth delay, extensive disease and/or
    structuring or penetrating disease, with or without perianal disease.
    Evaluation of the indication to start IFX is performed at the discretion of
    the attending physician.
    -Kinderen (1-15 jaar)
    -Geen eerdere behandeling met anti-TNF
    -Indicatie tot starten anti-TNF volgens ECCO-ESPGHAN richtlijn
    E.4Principal exclusion criteria
    Patients with the following characteristics will be excluded:
    - Established monogenetic IBD
    - Diagnosis with UC or IBD-U, ulcerative colitis like
    - Active fistulizing/perianal disease at start of IFX treatment (patients with inactive fistulizing/perianal disease are allowed to participate)
    - Severe comorbidity (not related to IBD)
    - Immediate need for surgery (i.e., symptomatic stenosis or stricture in the bowel)
    - Severe infection such as sepsis or opportunistic infections, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy
    - Pregnancy, suspected or definitive
    - Treatment with anti-TNF or other biological drugs in the past
    - Start of corticosteroids or mesalazine less than 2 weeks prior to first IFX infusion
    - Start of Exclusive Enteral Nutrition less than 2 week prior to first IFX infusion
    Patiënten met de volgende kenmerken zullen worden geexcludeerd:
    Bevestigde monogenetische IBD
    Diagnose van UC of IBD-U, ulceratieve colitis like
    Actieve fistelvormende/perianale ziekte bij aanvang van IFX-behandeling (patiënten met inactieve fistelvormende/perianale ziekte mogen deelnemen)
    Ernstige comorbiditeit (niet gerelateerd aan IBD)
    Onmiddellijke behoefte aan chirurgie (bijvoorbeeld symptomatische stenose of vernauwing in de darm)
    Ernstige infectie zoals sepsis of opportunistische infecties, positieve tuberculinetest of een thoraxfoto die consistent is met tuberculose of maligniteit
    Zwangerschap, vermoedelijk of definitief
    Behandeling met anti-TNF of andere biologische geneesmiddelen in het verleden
    Start van corticosteroïden of mesalazine minder dan 2 weken voorafgaand aan de eerste IFX-infusie
    Start van exclusieve enterale voeding minder dan 2 weken voorafgaand aan de eerste IFX-infusie




    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with IFX TL ≥ 5 μg/mL at week 12 without
    treatment escalation.
    Percentage patienten met IFX spiegels ≥ 5 μg/mL op week 12 zonder
    behandelintensificatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 weken
    E.5.2Secondary end point(s)
    • Proportion of patients with IFX TL ≥ 5 μg/mL at week 24 without the
    need for treatment escalation
    • Clinical and biochemical remission at weeks 4, 12, and 24 without the
    need for treatment escalation in patients with TL ≥ 5 μg/mL and in
    patients with TL < 5 μg/mL
    • Predictors of IFX TLs at weeks 4, 12, and 24. Factors included in this
    analysis will be sex, age, body mass index (BMI), wPCDAI, IBD
    laboratory values, ATI, dose, and interval of IFX infusions
    • Development of ATI until week 24
    • Prediction of patients who will respond vs. those who will not despite
    adequate TLs at weeks 12 and 24 based on proteomics analysis by
    OLINK
    • Evaluation of quality of life at baseline, weeks 4, 12, and 24 in all
    patients
    • Adverse event rate over time
    • Percentage patienten met IFX spiegels ≥ 5 μg/mL op week 24 zonder
    behandelintensificatie.
    • Klinische en biochemische remissie op week 4, 12 en 24 zonder
    behandelintensificatie bij patienten met IFX spiegel≥ 5 μg/m en
    patienten met IFX spiegel < 5 μg/mL.
    • Voorspellende factoren van IFX spiegels op week 4, 12 en 24.
    Covariaten die worden meegenomen in deze analyse zijn geslacht,
    leeftijd, body mass index (BM), wPCDAI, IBD lab, antistoffen tegen
    infliximab and dosering en interval van infliximab infusen.
    • Ontwikkeling van antistoffen tegen infliximab tot en met week 24.
    • Onderzoek naar voorspellende eiwitten (gebaseerd op OLINK analyse)
    op patienten die reageren vs niet reageren op behandeling met inflximab
    ondanks adequate infliximab spiegels
    • Kwaliteit van leven op baseline, week 12 en 24.
    • Aantal bijwerkingen tot en met 24 weken
    E.5.2.1Timepoint(s) of evaluation of this end point
    See within description of secondary endpoints
    Zie beschrijving van secundaire uitkomsten
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    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
    not applicable
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 27
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    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 No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Kinderen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 50
    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)
    None
    Geen
    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 Decision2022-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-04
    P. End of Trial
    P.End of Trial StatusOngoing
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