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    Summary
    EudraCT Number:2011-000311-34
    Sponsor's Protocol Code Number:MK8259-006(P07642)
    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:2011-12-06
    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 number2011-000311-34
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also known as MK-8259-006-00).
    Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo sull`™effetto di Golimumab (GLM) somministrato per via sottocutanea (SC) in soggetti con spondiloartrosi (SpA) assiale attiva (Fase 3b, Protocollo N. P07642, noto anche come MK-8259-006-00).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GO-AHEAD
    GO-AHEAD
    A.3.2Name or abbreviated title of the trial where available
    GO-AHEAD
    GO-AHEAD
    A.4.1Sponsor's protocol code numberMK8259-006(P07642)
    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 RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION
    B.1.3.4CountryUnited States
    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 supportSCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street Address2015 Galloping Hill Road
    B.5.3.2Town/ cityKenilworth, NJ
    B.5.3.3Post code07033
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 908 740 7324
    B.5.5Fax number001 908 740 2300
    B.5.6E-mailhaoling.weng@merck.com
    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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    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 Solution for injection
    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 INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.4EV Substance CodeSUB25638
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Axial Spondyloarthritis (SpA)
    Soggetti con diagnosi di SpA assiale attiva.
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory disease of the axial skeleton (bones of the head, spine and rib cage).
    Malattia infiammatoria cronica della colonna vertebrale
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 10021428 - Immune system 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 evaluate the effect of golimumab50 mg compared to placebo in the treatment of active axial SpA, as measured by proportion of subjects achieving Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16 and to demonstrate the safety and tolerability of golimumab 50 mg through Week 16 in the active axial SpA population.
    Valutare l’effetto di GLM 50 mg rispetto al placebo nel trattamento della SpA assiale attiva misurato come la proporzione di soggetti che presentano una risposta ASAS 20 (Assessment in Ankylosing Spondylitis) alla Settimana 16 e dimostrare la sicurezza e la tollerabilità di GLM 50 mg fino alla settimana 16 nella popolazione affetta da SpA assiale attiva.
    E.2.2Secondary objectives of the trial
    To evaluate the treatment effect of golimumab 50 mg compared to placebo as measured by the proportion of subjects achieving ASAS 40 response at Week 16. To evaluate the treatment effect of golimumab 50 mg compared to placebo, as measured by the proportion of subjects who achieve Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response at Week 16. To evaluate the treatment effect of golimumab 50 mg compared to placebo, as measured by the proportion of subjects who achieve ASAS partial remission at Week 16 To evaluate the treatment effect of golimumab 50 mg compared to placebo by the change in the Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) joints scoring from Baseline to Week 16.
    Valutare l’effetto di GLM 50 mg rispetto al placebo nel trattamento della SpA assiale attiva misurato come la proporzione di soggetti che presentano una risposta pari ad ASAS 40 alla Settimana 16. Valutare l’effetto di GLM 50 mg rispetto al placebo, sulla base della proporzione di soggetti che raggiungono l’Indice Bath dell’attività patologica della Spondilite Anchilosante (BASDAI) 50 alla Settimana 16. Valutare l’effetto di GLM 50 mg rispetto al placebo, sulla base della proporzione di soggetti che presentano una risposta ASAS di remissione parziale alla Settimana 16. Valutare alla Settimana 16 l’effetto del trattamento con GLM 50 mg rispetto al placebo, in riferimento alla variazione rispetto al basale del punteggio per l’articolazione sacroiliaca (SI), stabilito mediante Risonanza Magnetica (RM) dal Consorzio Spondiloartrite di Ricerca del Canada (SPARCC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Each subject must be >18 to <45 years of age. 2. Each subject must have a physician's diagnosis of active axial SpA with disease duration ≤5 years, and chronic back pain of ≥ 3 month duration. 3. Each subject must meet either criterion ''a'' or ''b'' as adopted from ASAS classification criteria: a. Active inflammation on MRI highly suggestive of sacroiliitis associated with spondyloarthropathy (as evidenced by the central reader) and 1 or more of the following spondyloarthritis characteristics OR b. HLA-B27+ gene and 2 or more of the following spondylarthritis characteristics (not including HLA-B27): ◦ Inflammatory back pain, defined as having at least 4 out of the 5 following parameters:  age at onset < 40 years;  insidious onset;  improvement with exercise;  no improvement with rest;  pain at night (with improvement upon getting up); ◦ Arthritis diagnosed by a physician; ◦ Enthesitis diagnosed by a physician; ◦ Dactylitis diagnosed by a physician; ◦ Psoriasis diagnosed by a physician; ◦ History of inflammatory bowel disease (IBD) diagnosed by a physician; ◦ History of uveitis confirmed by an ophthalmologist; ◦ Good response to NSAIDs ◦ Family history for SpA; ◦ Elevated CRP (> upper limit of normal based on central lab values); ◦ HLA-B27+ gene; 4. Each subject must show high disease activity at Screening and Baseline of both a total back pain evaluation of ≥40 mm on a VAS of 0- 100 mm and a BASDAI score of ≥ 40 mm. 5. Each subject must have either an inadequate response (as assessed by the investigator) to 30 days of continuous therapy with maximal recommended daily doses of at least one non-steroidal antiinflammatory drug (NSAID) or must be unable to receive a maximal dose of NSAID therapy for a full 30 days because of intolerance, toxicity, or contraindications to NSAIDs.
    1.Ciascun soggetto deve avere un’età compresa fra ≥18 e ≤45 anni. 2.Ciascun soggetto deve presentare una diagnosi di SpA assiale attiva, formulata da un medico, di durata ≤ 5 anni e con dolore cronico alla schiena della durata ≥ 3 mesi. 3.Ciascun soggetto deve soddisfare il criterio “a” o “b” in base ai criteri classificativi adottati dall’ASAS: a.Infiammazione attiva rilevata alla RM altamente evocativa di sacroileite associata a spondiloartropatia (come evidenziato dal lettore centrale) e 1 o più delle seguenti caratteristiche di spondiloartrosi OPPURE b.Gene HLA-B27+ e 2 o più delle seguenti caratteristiche della spondiloartrosi (escluso HLA-B27): ◦Dolore alla schiena di tipo infiammatorio, definito da almeno 4 dei seguenti 5 parametri: ��età all’esordio &lt; 40 anni; ��esordio insidioso; ��miglioramento con l’esercizio; ��nessun miglioramento con il riposo; ��dolore notturno (che migliora quando ci si alza); ◦Artrite diagnosticata da un medico; ◦Entesite diagnosticata da un medico; ◦Dattilite diagnosticata da un medico; ◦Psoriasi diagnosticata da un medico; ◦Anamnesi di malattia infiammatoria intestinale (IBD) diagnosticata da un medico; ◦Anamnesi di uveite confermata da un oculista; ◦Buona risposta ai FANS Nota: per “buona risposta” si intende “un periodo di 24-48 ore dopo una dose completa di FANS durante il quale non si lamenta più dolore alla schiena o il dolore è notevolmente diminuito”; ◦Anamnesi familiare di SpA; ◦CRP elevata (&gt; del limite superiore di normalità sulla base dei valori del laboratorio centrale); ◦Gene HLA-B27+; 4.Ciascun soggetto deve dimostrare patologia attiva alla visita di screening e al basale, sulla base sia di una valutazione totale del dolore alla schiena ≥ 40 mm su una VAS di 0-100 mm, sia di un punteggio BASDAI ≥ 40 mm. 5.Ciascun soggetto deve mostrare una risposta inadeguata (in base alla valutazione dello sperimentatore) dopo 30 giorni di terapia continuativa alle dosi massime giornaliere raccomandate di almeno un antinfiammatorio non steroideo (FANS) oppure deve non essere in grado di assumere una terapia a dosi massime di FANS per 30 giorni a causa di intolleranza, tossicità o controindicazioni all’assunzione di FANS. Note: è possibile che un soggetto abbia presentato una buona risposta iniziale ai FANS, ma che successivamente abbia riscontrato una risposta inadeguata per 30 giorni o abbia sviluppato intolleranza alla terapia con FANS.
    E.4Principal exclusion criteria
    1. The subject has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional X-rays (ie, excluding modified New York criteria) based on central reading at Screening. 2. The subject has ever received TNF-α targeted therapy or any biological agents, including but not limited to infliximab, etanercept, adalimumab, alefacept or efalizumab, rituximab, or natalizumab.
    1. Il soggetto presenta una sacroileite bilaterale di Grado 2 o una sacroileite monolaterale di Grado 3 o 4 alla radiografia convenzionale (escludendo cioè i criteri di New York modificati) in base alla lettura centrale durante la visita di screening. Note: per i soggetti sottoposti a radiografia articolare SI nei 3 mesi precedenti la visita di screening, il centro può inviare la radiografia per la lettura centrale. Se queste radiografie vengono considerate adeguate dopo la lettura centrale, in questi pazienti non è necessario ripetere la radiografia alle articolazioni SI durante lo screening. 2. Il soggetto ha già ricevuto una terapia mirata con TNF-α o con agenti biologici, ivi compresi, a titolo esemplificativo ma non limitativo, infliximab, etanercept, adalimumab, alefacept o efalizumab, rituximab o natalizumab. 3. Il soggetto ha già ricevuto farmaci citotossici, ivi compreso, a titolo esemplificativo ma non limitativo, clorambucile, ciclofosfamide, mostarda azotata o altri agenti alchilanti. 4.Farmaci, integratori e altre sostanze proibite
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the trial is the proportion of subjects meeting the ASAS 20 response at Week 16.
    L'endpoint primario di efficacia per la prova è la proporzione di soggetti che hanno la risposta ASAS 20 alla settimana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    16 settimane
    E.5.2Secondary end point(s)
    The Key Secondary Efficacy Endpoints are: • Proportion of subjects meeting the ASAS 40 response at Week 16; • Proportion of subjects achieving BASDAI 50 at Week 16; • Proportion of subjects in ASAS partial remission at Week 16; • Change in SPARCC MRI SI joints scoring from Baseline to Week 16.
    Gli endpoint secondari di efficacia chiave sono: • Percentuale di soggetti che hanno la risposta ASAS 40 alla settimana 16; • Percentuale di soggetti che hanno raggiunto BASDAI 50 alla settimana 16; • Percentuale di soggetti in remissione parziale ASAS alla settimana 16; • Variazione SPARCC MRI articolazioni SI punteggio dal basale alla settimana 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    16 settimane
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Russian Federation
    Turkey
    United States
    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 years0
    E.8.9.1In the Member State concerned months29
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months29
    E.8.9.2In all countries concerned by the trial days14
    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.1.2.1Number of subjects for this age range: 200
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 200
    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
    NON APPLICABILE
    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 Decision2012-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-15
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