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    Summary
    EudraCT Number:2005-004465-41
    Sponsor's Protocol Code Number:P04612
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-14
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-004465-41
    A.3Full title of the trial
    A multi-center, open-label trial evaluating the Efficacy, Safety and the Impact on Quality of Life of Infliximab Therapy in patients with moderate to severe psoriasis not responding and/or intolerant to systemic standard or biologic therapy - ESAQUALITY.
    Studio multicentrico in aperto per valutare l`efficacia, la tollerabilita` e l`influenza sulla Qualita` della Vita della terapia con Infliximab in pazienti con psoriasi moderata-severa resistenti e/o intolleranti a terapie sistemiche convenzionali o biologiche.
    A.3.2Name or abbreviated title of the trial where available
    ESAQUALITY
    ESAQUALITY
    A.4.1Sponsor's protocol code numberP04612
    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 SponsorSCHERING-PLOUGH
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 REMICADE*EV F 100MG+F 2ML
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH SpA *
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Moderate to severe psoriasis.
    Psoriasi da moderata a severa.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 objective is to assess the efficacy (PASI 75) of IFX (5 mg/kg) in adult subjects (aged 18 to 75 years) with moderate to severe chronic psoriasis not responding and/or intollerant to systemic standard or biologic therapies.
    Obiettivo primario e' valutare l'efficacia di Infliximab 5 mg/kg espressa in termini di PASI 75 in soggetti adulti (18-75 anni) affetti da psoriasi da moderata a severa resistenti e/o intolleranti a terapie sistemiche convenzionali o biologiche.
    E.2.2Secondary objectives of the trial
    To evaluate the safety, efficacy (PASI 50, 90, BSA, SAPASI) and the impact on QOL (SF-36, EQ-5D, SKINDEX 29, Itch Measure VAS) of IFX.
    Valutare la tollerabilita',l'efficacia (PASI 50,90,BSA,SAPAS)e l'impatto di Infliximab sulla qualita' di vita (SF-36,EQ-5D,SKINDEX 29,Itch Measure VAS).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI:
    Studio biochimico per valutare con tecniche immunoistochimiche la variazione nel numero e grado di attivazione dei diversi tipi di cellule dendritiche presenti nella cute psoriasica.
    E.3Principal inclusion criteria
    - Patients must be <=18 to 75 years of age, of eigher gender and of any race. - Patients must have psoriasis covering at least 10% of total BSA and PASI score of 12 or greater at screening and baseline. - Patients must have had a diagnosis of moderate to severe psoriasis at least 24 months prior to screening (patients with concurrent psoriatic arthritis may be enrolled). - Patients eligible to Infliximab treatment who have failed at least on of the following psoriasis treatments: Corticosteroids, MTX, systemic retinoids, Cyclosporine, PUVA, UVB phototherapy and/or biologics (etanercept or efalizumab). - Patients are considered eligible according to the tubercolosis (TB) eligibility assessment, screening and early detection of reactivation rules (specific section in the protocol). - Patients must have had a chest X-ray (posterior-anterior and lateral) within 3 months prior the screening with no evidence of malignancy, infections, or fibrosis. - Patients' screening and baseline test (CBC, blood chemistry, and urianalysis)must be within the following parameters: Hemoglobin: <= 10 g/dL White blood cells: <=3.5x109L Neutrophils: <=1.5x109L Platelets: <=100x109L Serum creatinine: >1.5 mg/dL AST, ALT, alkaline phosphatase and gamma-glutamyltransferase >= x upper normal limit of normal range for the laboratory conducting the test. Patients must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that could interfere with the study evaluation. Patients must be willing to give written informed consent and be able to adhere to protocol visit and procedures.
    - Pazienti adulti (eta': 18-75 anni) di sesso femminile e maschile, di qualsiasi gruppo etnico. - Pazienti con psoriasi a placche con interessamento di almeno il 10% della superficie corporea totale (BSA:&lt;=10%) e con valore del PASI di almeno 12 alla visita 1 (screening) e alla visita 2 (basale). - Pazienti con diagnosi di psoriasi a placche da moderata a severa formulata almeno 6 mesi prima della visita di screening (possono essere arruolati pazienti con concomitante artrite psoriasica). - Pazienti eleggibili al trattamento con infliximab che siano resistenti ad almeno una delle terapie sistemiche convenzionali (metotressato, retinoidi, ciclosporina, PUVA-terapia, fototerapia con UVB) e/o con farmaci biologici (etanercept, efalizumab) e/o in cui le suddette terapie non possono essere utilizzate per problemi di tollerabilita', compliance e/o controindicazioni. - Pazienti che presentino i requisiti di idoneita' ai test di screening e di diagnosi di tubercolosi (secondo procedure descritte nel paragrafo 8.11 del protocollo). - Pazienti in cui la radiografia del torace in 2 proiezioni effettuata nei 3 mesi precedenti la visita di screening non abbia evidenziato segni di neoplasia, infezione o fibrosi. - Pazienti in cui gli esami di laboratorio eseguiti alla visita 1 (o nel periodo compreso tra visita 1 e visita 2) abbiano mostrato parametri inclusi nei seguenti valori: Emoglobina: &lt;=10 g/dL Globuli bianchi: &lt;=3,5x10MLD Neutrofili: &lt;=1,5x10MLD Piastrine: &lt;=100x10MLD Creatininemia: &gt;1,5 mg/dL Transaminasi (AST, ALT), fosfatasi alcalina, bilirubina totale e gamma-glutamiltransferasi &gt;=1,5 volte il limite superiore del range di normalita'. - Pazienti che non siano affetti da malattie clinicamente rilevanti (eccezion fatta per psoriasi o artrite psoriasica) che possano interferire con le valutazioni previste nello studio. - Pazienti che abbiano manifestato la loro volonta' a partecipare allo studio, rilasciando il proprio consenso informato, e che siano in grado di sottoporsi alle visite e procedure dello studio.
    E.4Principal exclusion criteria
    - Standard concomitant psoriasis therapies. - Active or latent TB. - History of chronic infectious disease, opportunistic infection or serious infection within 2 months of enrollment. - History of lymphoproliferative disease. - Malignancy in past 5 years (except treated BCC). - Treatment with TNF antagonist within previous 12 weeks or other experimental drugs within previous 4 weeks. - Patients who have current-drug induced psoriasis. - Female patients who are pregnant or nursing. Patients previously treated with Infliximab. - Patients who have a concomitant diagnosis of CHF.
    - Terapie concomitanti con la psoriasi. - TB attiva o latente. - Storia di malattie infettive croniche, infezioni opportunistiche o infezioni serie entro due mesi dall'arruolamento. - Storia di malattia linfoproliferativa. - Neoplasie negli ultimi 5 anni (eccettuati epiteliomi basocellulari trattati senza recidiva). - Trattamento con antagonisti del TNF-alfa nelle precedenti 12 settimane o con farmaci sperimentali nelle 4 settimane precedenti l'arruolamento. - Pazienti in trattamento con farmaci che inducano psoriasi. - Pazienti di sesso femminile che siano in gravidanza o allattamento. - Pazienti precedentemente trattati con Infliximab. - Pazienti con concomitante diagnosi di insufficienza cardiaca congestizia.
    E.5 End points
    E.5.1Primary end point(s)
    PASI 75 response rate at week 10 will be evaluated. PASI 75 will be summarized by counts and percentages. The PASI 75 response rate will be estimated and its 95% Confidence Interval will be calculated.
    Sara' valutata la frequenza di risposta in termini di PASI 75 alla settimana 10, in numero assoluto ed in percentuale di pazienti. Sara' fatta una stima della frequenza e sara' calcolato l'intervallo di confidenza al 95%.
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned38
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 2006-03-14. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state215
    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 Decision2006-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-25
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