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    Summary
    EudraCT Number:2011-003038-14
    Sponsor's Protocol Code Number:2010-2
    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:2012-05-31
    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 number2011-003038-14
    A.3Full title of the trial
    A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE
    Een gerandomiseerd, gecontroleerd onderzoek naar een passende behandeling met Infliximab bij patiënten met actieve luminale ziekte van Crohn.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE
    Een gerandomiseerd, gecontroleerd onderzoek naar een passende behandeling met Infliximab bij patiënten met actieve luminale ziekte van Crohn.
    A.3.2Name or abbreviated title of the trial where available
    TAILORIX
    A.4.1Sponsor's protocol code number2010-2
    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 SponsorGETAID
    B.1.3.4CountryFrance
    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 supportJanssen Biologics
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMERCK
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGETAID
    B.5.2Functional name of contact pointDETRE PATRICIA
    B.5.3 Address:
    B.5.3.1Street Address1 AVENUE CLAUDE VELLEFAUX
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33142494988
    B.5.5Fax number33142496891
    B.5.6E-mailarc.getaid@gmail.com
    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.2.1.1.1Trade name INFLIXIMAB
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN BIOLOGICAL BV
    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 Suspension 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 codeINFLIXIMAB
    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) 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
    Luminal active Crohn's Disease
    Luminale ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    Active Crohn's Disease
    Actieve ziekte van Crohn
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorythms in comparison with ‘standard of care’ IFX treatment and its effects on clinical and endoscopic outcomes
    Het doel van het onderzoek is het vergelijken van de effectiviteit van de behandeling met infliximab, bij patiënten die behandeld worden volgens de standaard versus patiënten die behandeld worden op geleide van de bloedspiegels.
    E.2.2Secondary objectives of the trial
    • Clinical remission (CDAI <150) at each visit and the whole study period
    • Endoscopic evaluation at week 0, 12 and 54
    Effect van de behandeling wordt bepaald aan de hand van steroïden-vrije remissie (na week 26), daarbij mucosale heling bij endoscopie op week 54 en uitblijven van chirurgie gedurende het hele jaar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years
    - Active CD (CDAI>220) and signs of active inflammation as evidenced by elevated serum hsCRP levels (>5 mg/L) and/or elevated fecal calprotectin levels (>250 µg/g) and endoscopically visible ulcers.
    - Patients must be naïve to biologics with indication for starting anti-TNF therapy in accordance with national reimbursement criteria.
    - Patients must be naïve to thiopurines or have failed therapy with thiopurines (in which case AZA will be continued).
    - Ongoing steroids are allowed if at stable dose for at least 2 weeks and at a maximum of prednisone 40 mg/d or budesonide 9 mg/day.
    - Patients who consent to receiving Infliximab 5 mg/kg at week 0, 2 and 6 and further on every 8 weeks in conjunction with azathioprine (2,5 mg/kg/day). Patients who develop AZA intolerance during the trial are continued in the trial without AZA (ie IFX monotherapy).
    Leeftijd >18 jaar,
    Actieve ziekte van Crohn (CDAI>220) en tekenen van actieve ontsteking bewezen voor verhoogd serum CRP (>5mg/L) en/of verhoogd fecale calprotectine waarde (>250 mcg/g) EN endoscopisch zichtbare ulceraties,
    Patiënten naïef voor biologicals met een indicatie tot het starten met anti-TNF therapie overeenkomstig met de landelijk geldende vergoedingsvoorwaarden
    E.4Principal exclusion criteria
    - Absence of endoscopically visible ulcers
    - Prior exposure to infliximab (other biologics allowed)
    - Ongoing steroid therapy at doses > 40 mg/d prednisolone equivalent
    - Previous intolerance to azathioprine leading to drug discontinuation
    - Ongoing infections
    - Positive tuberculosis screen per local guidelines
    - Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer
    - Indication for immediate surgery
    - Pregnant or breast-feeding woman.
    - Positive fecal culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools
    - Active tuberculosis
    - Untreated latent tuberculosis
    - Gebruik infliximab in voorgeschiedenis (andere biologicals toegestaan)
    - Huidig behandeling met steroïden met doseringen > 40 mg/d (prednisolon equivalent)
    - Intolerantie voor azathioprine in voorgeschiedenis, welke geleid heeft tot staken ervan.
    - Infecties aanwezig bij screening
    - Positieve tuberculose test volgens lokale richtlijnen
    - Indicatie voor chirurgie op zeer korte termijn
    - Positieve faeces kweken voor Salmonella, Shigella, Yersinia and Campylobacter en/of aanwezigheid van Clostridium difficile B toxine in de ontlasting
    - Actieve tuberculose
    - Onbehandelde latente tuberculose
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in corticosteroid-free remission (no steroids beyond week 26), with endoscopic healing at week 54 and without surgery for the full year.
    Effect van de behandeling wordt bepaald aan de hand van steroïden-vrije remissie (na week 26), daarbij mucosale heling bij endoscopie op week 54 en uitblijven van chirurgie gedurende het hele jaar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 54 after inclusion
    Week 54 na inclusie
    E.5.2Secondary end point(s)
    Each visit for clinical remission
    Week 0, week 12 and week 54 for endoscopic evaluation
    Ieder bezoek op klinische remissie
    Week 0, week 12 en week 54 endoscopische evaluatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each visit
    Week 0, week 12 and week 54 for endoscopic evaluation
    Ieder bezoek
    Week 0, week 12 en week 54 voor de endoscopische evaluatie
    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 No
    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 No
    E.8.1.3Single blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Zelfde geneesmiddel, eventueel met andere dosering
    Same medical product at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 Yes
    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
    Last visit of the trial
    Laatste visite van laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Not Applicable
    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 Decision2012-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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