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    The EU Clinical Trials Register currently displays   37743   clinical trials with a EudraCT protocol, of which   6185   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005702-37
    Sponsor's Protocol Code Number:TISKids
    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:2015-02-12
    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 number2014-005702-37
    A.3Full title of the trial
    Top-Down Infliximab Study in Kids with Crohn's disease (TISKids)
    Top-down Infliximab Studie bij Kinderen met de ziekte van Crohn (TISKids)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early infliximab use in kids with Crohn's disease (TISKids)
    Vroegtijdig infliximab gebruik bij kinderen met de ziekte van Crohn (TISKids)
    A.3.2Name or abbreviated title of the trial where available
    Top-down Infliximab in Kids with Crohn's disease (TISKids)
    Top-down Infliximab bij Kinderen met de ziekte van Crohn (TISKids)
    A.4.1Sponsor's protocol code numberTISKids
    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 supportZonMW
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportHospira
    B.4.2CountryUnited States
    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 AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CN
    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.2.1.1.1Trade name Inflectra
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.3Other descriptive nameInflectra
    D.3.9.4EV Substance CodeSUB02681MIG
    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 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
    To determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.
    Om de effectiviteit en veiligheid van top-down infliximab te bepalen in kinderen met matig-ernstige ziekte van Crohn
    E.2.2Secondary objectives of the trial
    Determination of pharmacokinetic/-dynamic profile of IFX and finding predictors of response to IFX in pediatric CD
    Nader bepalen van het farmacokinetisch en -dynamisch profiel van infliximab in kinderen met de ziekte van Crohn en om voorspellende markers van respons te identificeren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosed with Crohn's disease
    Moderate-to-severe disease activity
    Aged 3-17
    Untreated
    Gediagnosticeerd met de ziekte van Crohn
    Matig tot ernstige ziekteactiviteit
    Leeftijd 3-17 jaar
    Onbehandeld
    E.4Principal exclusion criteria
    Need for surgery
    Severe comorbidity or severe infection
    Active perianal fistulas
    Pregnancy
    Operatie indicatie
    Ernstige comborbiditeit of ernstige infectie
    Active perianale fistels
    Zwangerschap
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission at 52 weeks without need for additional CD related therapy or surgery.
    Percentage van klinische remissie op 52 weken zonder dat aanvullende CD gerelateerde therapie is gebruikt of operaties zijn verricht.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 weken
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    • Clinical response (decrease in wPCDAI >17.5) and remission (wPCDAI <12.5) rates at week 10
    • Mucosal healing rates at week 10 assessed by endoscopy (absence of ulcers) and calprotectin (<100 µg/g), and at week 52 assessed by endoscopy (performed on a voluntary basis, or if clinically indicated) and/or calprotectin
    • Growth (change in height and BMI Z-scores, bone age and pubertal development)
    • Quality of life at week14 and 52 (IMPACT III)
    • Therapy failure rates over time (primary non-response, loss of response and medication intolerance)
    • Cumulative therapy use (steroids, immunomodulators, biologicals, etc)

    Secondary safety endpoints
    • Adverse events rates
    • Complication rate at 52 weeks (fistulas, abscesses, strictures, surgery, extra-intestinal manifestations)

    Long-term follow-up endpoints (5 years)
    • Yearly clinical remission rates without need for additional CD-related therapy or surgery
    • Yearly clinical response, clinical remission and mucosal healing rates
    • Number of flairs
    • Quality of life at 5 years
    • Cumulative therapy use (steroids, immunomodulators, biologicals, etc)
    • Adverse events rate
    • Complication rate (fistulas, abscesses, strictures, surgery, extra-intestinal manifestations)

    Sub analyses
    • Correlation between clinical disease activity, fecal calprotectin and endoscopic disease severity
    • Comparing efficacy and safety endpoints between the two step-up treatment options (prednisolon+AZA vs EEN+AZA)

    Additional objectives
    • Determination of PK/PD properties of IFX in children
    • Identification of predictive biomarkers of response to IFX
    • Comparing cost-efficacy of top-down versus step-up
    Secundaire effectiviteits uitkomstmaten
    • Klinische response en remissie percentages op week 10
    • Mucosaal herstel op 10 weken en 52 weken, bepaald door endoscopie en/of calprotectine
    • Groei (toename in lengte en BMI Z-scores, botleeftijd en geslachtsrijping)
    • Toename in kwaliteit van leven op week 14 en 52
    • Het voorkomen van therapie falen over tijd (primair non-response, verlies van response en falen vanwege medicatie bijwerkingen)
    • Cumulatief therapie gebruik (steroïden, immunomodulatoren, biologicals, etc)

    Secondaire veiligheids uitkomstmaten
    • Bijwerkingen
    • Complicaties op 52 weken (fistels, abscessen, strictuur vorming, operaties, extra-intestinale manifestaties)

    Lange-termijn uitkomstmaten (5 jaar)
    • Jaarlijkse klinische remissie percentage zonder dat aanvullende CD gerelateerde therapie is gebruikt of operaties zijn verricht.
    • Jaarlijkse klinische respons, remissie en mucosaal herstel percentages
    • Aantal ziekte opvlammingen
    • Kwaliteit van leven
    • Cumulatief therapie gebruik (steroïden, immunomodulatoren, biologicals, etc)
    • Bijwerkingen en complicaties (fistels, abscessen, strictuur vorming, operaties, extra-intestinale manifestaties)

    Subanalyses
    • Relatie tussen klinische ziekte activiteit, calprotectine en endoscopische ziekte ernst
    • Vergelijken effectiviteit- en veiligheidsuitkomstmaten tussen de twee step-up behandelmethoden (prednisolon+AZA vs EEN+AZA)

    Additioneel onderzoek
    • Bepalen van het farmacokinetisch profiel van infliximab in kinderen
    • Onderzoek naar voorspellende factoren voor respons op infliximab
    • Vergelijken van kost-effectiviteit van top-down versus step-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 10, 52 and/or 260
    Week 10, 52 en/of 260
    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 Yes
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 years6
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days25
    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: 100
    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: 20
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 80
    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 2015-02-12. 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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 Decision2015-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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