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    The EU Clinical Trials Register currently displays   42771   clinical trials with a EudraCT protocol, of which   7044   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-004393-16
    Sponsor's Protocol Code Number:NL55231.041.15
    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:2016-07-08
    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 number2015-004393-16
    A.3Full title of the trial
    Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis.
    Biomarker-gestuurde behandelstrategie voor anakinra in systemische Juveniele Idiopathische Arthritis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biomarker-guided treatment-and-stop-strategy for short acting IL-1 blockade in patients with systemic Juvenile Idiopathic Arthritis.
    Biomarker-gestuurde behandelstrategie voor anakinra in systemische Juveniele Idiopathische Arthritis.
    A.3.2Name or abbreviated title of the trial where available
    ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIA
    ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIA
    A.4.1Sponsor's protocol code numberNL55231.041.15
    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 SponsorUniversity Medical Center Utrecht
    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 supportNetherlands Organisation for Health Research and Develpment ZonMW, Rational Pharmacotherapy program
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSwedish Orphan Biovitrium AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointBO&O, Bureau Onderzoek & onderwijs
    B.5.3 Address:
    B.5.3.1Street AddressLundlaan 6
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584EA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31887550871
    B.5.6E-mailm.musbach@umcutrecht.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 kineret® or anakinra
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    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 nameanakinra / kineret
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.2Current sponsor codeAnakinra
    D.3.9.3Other descriptive namerIL-1RA
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    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
    systemic Juvenile Idiopathic Arthritis
    Systemische Jeugdreuma
    E.1.1.1Medical condition in easily understood language
    Systemic juvenile idiopathic arthritis
    systemische jeugdreuma
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to develop a biomarker guided treatment and stop strategy for rIL-1RA in systemic Juvenile Idiopathic Arthritis
    de ontwikkeling van een biomarker geleide stop strategie voor het gebruik van rIL- 1RA in systemische jeugdreuma
    E.2.2Secondary objectives of the trial
    - the total number of disease flares during or after tapering and stop of therapy in the first year
    - the number of patients with remission off medication at time point 1 and 2 years
    - the total number of injections of anakinra per patient in the first year
    - the number of patients needing to switch treatment because of treatment failure during the first year
    - the number of (serious) adverse events in the first year.
    - Het totale aantal ziekte-relapses tijdens of na het stoppen van de therapie in het eerste jaar
    - Het aantal patiënten met een remissie off medicatie op tijdstippen 1 en 2 jaar
    - Het totaal aantal injecties van anakinra per patiënt in het eerste jaar
    - Het aantal patiënten dat moet switchen van behandeling vanwege non-respons op rIL-1RA gedurende het eerste jaar
    - Het aantal (ernstige) bijwerkingen in het eerste jaar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children and adolescents diagnosed with sJIA;

    2. Both male and female patients, aged 8 months - 16 years (anakinra is approved in children aged 8 months and older who suffer from CAPS, and as per definition, JIA has an onset before the age of 16);

    3. Patients treated with anakinra as first line therapy who showed an initial response to anakinra (no fever on day 7);
    4. Parents or legal guardian (and the subject when age is appropriate) who are willing to sign the consent/assent forms.
    1. Kinderen gediagnosticeerd met systemische JIA;

    2. Zowel mannelijke als vrouwelijke patiënten, in de leeftijd van 8 maanden - 16 jaar (anakinra is goedgekeurd bij kinderen van 8 maanden en ouder die last hebben van CAPS, en als per definitie JIA heeft een begin vóór de leeftijd van 16);

    3. Patiënten die met anakinra als eerste lijn therapie een initiele goede respons op anakinra tonen (geen koorts meer op dag 7 na starten anakinra)
    4. Informed consent van ouders of wettelijke voogd en/of patient bji leeftijd > 12 jaar.
    E.4Principal exclusion criteria
    1. An onset of Macrophage Activation Syndrome (MAS) simultaneously with sJIA or after the diagnosis of sJIA will lead to exclusion of a (potential) subject from participation in this study;
    2. Previous steroid treatment in the 3 months before diagnosis.
    1. Macrofaagactivatiesyndroom (MAS) bij start van de ssystemische JIA of na de diagnose van systemische JIA
    2. Eerdere behandeling met steroïden in de 3 maanden voordat de diagnose.
    E.5 End points
    E.5.1Primary end point(s)
    The number of patients with ‘clinically inactive disease’ without medication at time point 1 year after the start of anakinra (rIL-1RA)
    Het aantal patiënten met 'klinisch inactieve ziekte' zonder medicatie op tijdstip 1 jaar na starten van anakinra (rIL-1RA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time point 1 year after the start of anakinra (rIL-1RA)
    Tijdstip 1 jaar na starten van anakinra (rIL-1RA)
    E.5.2Secondary end point(s)
    * the total number of disease flares during or after tapering and stop of therapy (rIL-1RA) in the first year;
    * the number of patients with remission off medication at time point 1 and 2 years;
    * the total number of injections of anakinra per patient;
    * the number of patients needing to switch treatment because of treatment failure during the first year
    * the number of (serious) adverse events in the first year.
    * Het totale aantal ziekte-relapses gedurende of na stoppen van de therapie (rIL-1RA) in het eerste jaar;
    * Het aantal patiënten met een remissie off medicatie op tijdstip 1 en 2 jaar;
    * Het totale aantal injecties van anakinra per patiënt;
    * Het aantal patiënten dat moet switchen van behandeling vanwege ziekte relapse gedurende het eerste jaar
    * Het aantal (ernstige) bijwerkingen in het eerste jaar.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time point 1 and 2 years after the start of anakinra (rIL-1RA)
    Tijdstip 1 en 2 jaar na starten van anakinra (rIL-1RA)
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    open-label stop trial
    open-label stop trial
    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 concerned6
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    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: 55
    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: 35
    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 Yes
    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 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 in the age between 8 months and 16 years
    Kinderen in de leeftijd tussen 8 maanden en 16 jaar
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    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 Decision2016-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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