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    Summary
    EudraCT Number:2017-004588-11
    Sponsor's Protocol Code Number:ABR64005
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-09-10
    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 number2017-004588-11
    A.3Full title of the trial
    Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease.
    Veilige controle van de ziekte van Crohn trial: Lang termijn effectiviteit en veiligheid van periodieke behandeling met adalimumab versus standaard step-up behandeling van nieuwe patiënten met de ziekte van Crohn.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment.
    Veilige controle van de ziekte van Crohn trial: Lang termijn effectiviteit en veiligheid van 6 maanden behandeling met adalimumab versus standaard step-up behandeling van nieuwe patiënten met de ziekte van Crohn.
    A.3.2Name or abbreviated title of the trial where available
    CoCroS trial
    CoCroS studie
    A.4.1Sponsor's protocol code numberABR64005
    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 Maastricht
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Maastricht
    B.5.2Functional name of contact pointNutrim
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 40
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 ER
    B.5.3.4CountryNetherlands
    B.5.6E-mailm.pierik@mumc.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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie
    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.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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) Yes
    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
    The chronic inflammatory bowel disease Crohn's disease
    De chronische inflammatoire darmaandoening de ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory disease of the bowel Crohn's disease
    De chronische darmontsteking de ziekte van Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 aim of this study is to compare the long-term efficacy and safety of standard step-care with corticosteroid/budesonide as the initial treatment, with step-care with adalimumab as initial treatment for newly diagnosed CD patients.
    Primary outcome
    Quartiles of clinical and biochemical disease remission at week 96
    Het doel van deze studie is om de lange termijn effectiviteit en veiligheid van periodieke behandeling met adalimumab als initiële behandeling te vergelijken met de standaard step-care bij patiënten met (een nieuwe diagnose van) de ziekte van Crohn.
    E.2.2Secondary objectives of the trial
    Safety outcome
    Disease progression at week 96 on MRI-enterography
    Drug related serious adverse events
    Serious disease related adverse events (hospitalisation, surgery)

    Secondary outcomes
    Total health care costs at week 96
    Cumulative corticosteroid dose at week 24, 48 and 96
    Proportion of endoscopic remission at week w24
    time to remission
    PROM: quality of life week 24, 48 and 96
    PROM: (work) disability week 24, 48 and 96
    PROM: tolerability of treatment week 24, 48 and 96
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Newly diagnosed CD patients or patients with a flare of an established diagnosis visiting the outpatient clinic or endoscopy ward of the participating centres.
    - naïve to biologicals or thiopurines
    - CD diagnosis according to ECCO-guidelines including complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography)
    - Sufficient knowledge Dutch language
    - 18 years old ≤ 70 years old
    - Smartphone with internet access
    - Use of myIBDcoach or willingness to start using myIBDcoach
    • Nieuw gediagnosticeerde CD-patiënten of patiënten met een opvlamming van een vastgestelde diagnose die de polikliniek of endoscopie-afdeling van de deelnemende centra bezoeken.
    - naïef voor biologicals of thiopurines
    • CD-diagnose volgens ECCO-richtlijnen inclusief volledige ileo-colonoscopie + volledige beeldvorming van de dunne darm bij diagnose (MRI of CT-enterografie)
    • Voldoende kennis van de Nederlandse taal
    • 18 jaar oud ≤ 70 jaar oud
    • Smartphone met internettoegang
    - gebruik van mijnIBDcoach
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Malignancy in 5 years before treatment. Exception adequate treated non-melanoma skin cancer
    • active perianal fistula at diagnosis
    • Sever disease requiring hospitalisation at diagnosis/inclusion
    • Contra-indication for anti-TNF or immunosuppressive
    - Patients with the short bowel syndrome or an ostomy
    - use of corticosteroids for a duration longer than 4 months in the year before screening
    - contra-indication for MRI- and CT-enterography
    • Maligniteit in 5 jaar vóór de behandeling. Uitzondering voldoende behandelde niet-melanoom huidkanker
    • Actieve perianale fistel bij diagnose
    • Ernstige ziekte waarvoor ziekenhuisopname nodig is bij diagnose
    • Contra-indicatie voor TNF-blokkers of immunosuppressiva
    •Contra-indicatie voor een MRI
    •Patiënten met het korte-darm syndroom of een stoma
    - gebruik van corticosteroïden gedurende meer dan 4 maanden in het jaar voor de screening
    - Contra-indicatie voor MRI-en CT-enterografie
    E.5 End points
    E.5.1Primary end point(s)
    Quartiles of clinical and biochemical disease remission at week 96
    Het primaire eindpunt is het verschil in aantal kwartalen van corticosteroïd vrije klinische en biochemische remissie op week 96.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 96
    week 96
    E.5.2Secondary end point(s)
    Safety outcome
    Disease progression at week 96 on MRI-enterography
    Drug related serious adverse events
    Serious disease related adverse events (hospitalisation, surgery)

    Secondary outcomes
    Total health care costs at week 96
    Cumulative corticosteroid dose at week 24, 48 and 96
    Proportion of endoscopic remission at week w24
    time to remission
    PROM: quality of life week 24, 48 and 96
    PROM: (work) disability week 24, 48 and 96
    PROM: tolerability of treatment week 24, 48 and 96
    De secundaire uitkomsten zijn de totale kosten voor gezondheidszorg, de cumulatieve dosis corticosteroïden, het deel van de patiënt met endoscopische remissie w24, geneesmiddelgerelateerde bijwerkingen en door de patiënt gerapporteerde uitkomstmaten voor de kwaliteit van leven, (arbeids) beperkingen en tolerantie van de behandeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2.
    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 Yes
    E.8.2.3.1Comparator description
    Standaard Step-up behandeling
    Standard Step-up treatment
    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 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
    Laatste visite van Laatste deelnemer
    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 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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 158
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state158
    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 Decision2019-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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