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    Summary
    EudraCT Number:2015-000481-58
    Sponsor's Protocol Code Number:MLN0002SC-3031
    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:2021-02-11
    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 number2015-000481-58
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance
    Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
    Studio di fase 3, randomizzato, in doppio cieco, controllato verso placebo condotto per valutare l¿efficacia e la sicurezza di vedolizumab per via sottocutanea come terapia di mantenimento in soggetti con malattia di Crohn in fase attiva di grado da moderato a grave, che hanno ottenuto una risposta clinica a seguito di terapia endovenosa con vedolizumab in aperto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn's Disease
    Efficacia e sicurezza di Vedolizumab SC come terapia di mantenimento nella malattia di Crohn
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn's Disease
    Efficacia e sicurezza di Vedolizumab SC come terapia di mantenimento nella malattia di Crohn
    A.4.1Sponsor's protocol code numberMLN0002SC-3031
    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 SponsorTAKEDA DEVELOPMENT CENTRE EUROPE LTD
    B.1.3.4CountryUnited Kingdom
    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 supportTakeda Development Center Americas, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe Ltd
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaloperations@tgrd.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 Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameVedolizumab IV
    D.3.2Product code MLN0002
    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 INNVedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor code.MLN0002 SC
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 No
    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 nameVedolizumab SC
    D.3.2Product code MLN0002 SC
    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 INNVedolizumab SC
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002 SC
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number108
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    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
    Crohn's Disease
    malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    malattia di Crohn
    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 20.0
    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 assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active CD who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.
    Valutare l¿effetto del trattamento di mantenimento con vedolizumab SC sulla remissione clinica alla Settimana 52 nei soggetti affetti da CD attiva da moderata a grave, che hanno ottenuto una risposta clinica alla Settimana 6 dopo la somministrazione di vedolizumab EV alle Settimane 0 e 2.
    E.2.2Secondary objectives of the trial
    ¿ To determine the effect of vedolizumab SC maintenance treatment on enhanced clinical response at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.

    ¿ To determine the effect of vedolizumab SC maintenance treatment on corticosteroid-free remission at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.
    ¿Valutare l¿effetto del trattamento di mantenimento con vedolizumab SC sulla risposta clinica potenziata alla Settimana 52 nei soggetti che hanno ottenuto una risposta clinica alla Settimana 6 dopo la somministrazione di vedolizumab EV alle Settimane 0 e 2.

    ¿Valutare l¿effetto del trattamento di mantenimento con vedolizumab SC sulla remissione senza corticosteroidi alla Settimana 52 nei soggetti che hanno ottenuto una risposta clinica alla Settimana 6 dopo la somministrazione di vedolizumab EV alle Settimane 0 e 2.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Ileonoscopy Sub-study (Version and Date per Main Study)
    Related objective: To determine the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2, using an alternate definition of clinical remission based on endoscopy (using simple endoscopic score for
    Crohn's Disease [SES-CD]), abdominal pain (using the CDAI component) and loose/watery stool frequency (using the CDAI component).
    Ileocolonoscopy assessments will be performed at sites with appropriate capabilities, in subjects who volunteer at screening. The purpose of this
    assessment is to explore an alternate definition of clinical remission at Week 52 based on endoscopy (using SES-CD), abdominal pain (using the CDAI component) and loose/watery stool frequency (using the CDAI component). Ileocolonoscopy assessments (including terminal ileum plus ascending, traverse, decending and sigmoid colon and rectum) will be performed prior to Week 0 dosing and at Week 52 by a local endoscopist.


    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di ileocolonscopia (versione e data
    in base allo studio principale)
    Relativo obiettivo: Determinare l¿effetto del trattamento di mantenimento con vedolizumab SC sulla remissione clinica alla Setti 52 nei soggetti che hanno ottenuto una risposta clinica alla Sett 6 dopo la somministrazione di vedolizumab EV alle Sett 0 e 2, usando una definizione alternativa di remissione clinica basata su endoscopia (con punteggio endoscopico semplice per CD [Simple Endoscopic Score for Crohn¿s disease, SES-CD]), dolore addominale (con indice di attivit¿ della CD[Crohn¿s Disease Activity Index, CDAI]) e frequenza delle feci molli/liquide (tramite il componente CDAI)
    Le valutazioni dell¿ileocolonscopia saranno effettuate presso i centri con idonee competenze, nei soggetti che si offrono come volontari allo screening. Lo scopo di questa valutazione consiste nell¿esplorare una definizione alternativa di remissione clinica alla Sett 52 basata sull¿endoscopia (con punteggio endoscopico semplice per la malattia di Crohn [Simple Endoscopic Score for Crohn¿s Disease, SES-CD]), dolore addominale (con indice di attivit¿ della malattia di Crohn [Crohn¿s Disease Activity
    Index, CDAI]) e frequenza delle feci molli/liquide (con il componente CDAI). Le valutazioni dell¿ileocolonscopia (incluso ileo terminale pi¿ colon ascendente, trasversale, discendente e sigmoideo e retto) saranno eseguite prima della somministrazione alla Settimana 0 e alla Sett 52 da parte di un endoscopista locale.
    E.3Principal inclusion criteria
    1. The subject has a diagnosis of Crohn's disease (CD) established at least 3 months prior to screening, by clinical and endoscopic evidence
    and corroborated by a histopathology report.
    2. The subject has moderately to severely active CD.
    3. The subject has CD involvement of the ileum and/or colon, at a minimum.
    4. The subject has extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence
    that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
    5. Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance at
    screening.
    6. The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or TNF-alpha antagonists.
    1.Il soggetto ha una diagnosi di CD stabilita almeno 3 mesi prima dello screening tramite evidenza clinica ed endoscopica e corroborata da un referto istopatologico.
    2.Il soggetto presenta CD in fase attiva di grado da moderato a grave.
    3.Il soggetto presenta CD con coinvolgimento almeno dell’ileo e/o del colon.
    4.Il soggetto con colite estesa o pancolite da >8 anni o colite limitata da >12 anni deve dimostrare che è stata effettuata una colonscopia di controllo entro 12 mesi dalla visita di screening iniziale.
    5.I soggetti con anamnesi familiare di cancro del colon-retto, anamnesi personale di rischio aumentato di cancro del colon-retto, di età >50 anni o altri fattori di rischio noti devono aver effettuato i controlli previsti per il cancro del colon-retto allo screening.
    6.Il soggetto ha dimostrato una risposta non adeguata, una perdita della risposta o intolleranza ad almeno 1 dei seguenti agenti: immunomodulatori, corticosteroidi o antagonisti del TNF-a
    E.4Principal exclusion criteria
    1. The subject has evidence of abdominal abscess at the initial Screening
    Visit.
    2. The subject has had extensive colonic resection, subtotal or total
    colectomy.
    3. The subject has a history of >3 small bowel resections or diagnosis of
    short bowel syndrome.
    4. The subject has received tube feeding, defined formula diets, or
    parenteral alimentation within 21 days prior to the administration of the
    first dose of study drug.
    5. The subject has had ileostomy, colostomy, or known fixed
    symptomatic stenosis of the intestine.
    6. The subject has received any of the investigational or approved nonbiologic
    therapies (eg, cyclosporine, tacrolimus, thalidomide,
    methotrexate, or tofacitinib except for those specifically listed in the
    protocol) for the treatment of underlying disease within 30 days or 5
    half-lives of screening (which ever is longer).
    7. The subject has received any investigational or approved biologic or
    biosimilar agent within 60 days or 5 half-lives of screening (which ever
    is longer).
    8. The subject has used topical (rectal) treatment with 5-ASA or
    corticosteroid enemas/suppositories within 2 weeks of the
    administration of the first dose of study drug.
    9. The subject requires currently or is anticipated to require surgical
    intervention for CD during the study.
    10. The subject has a history or evidence of adenomatous colonic polyps
    that have not been removed.
    11. The subject has a history or evidence of colonic mucosal dysplasia.
    12. The subject has a suspected or confirmed diagnosis of ulcerative
    colitis, indeterminate colitis, ischaemic colitis, radiation colitis,
    diverticular disease associated with colitis, or microscopic colitis.
    13. The subject has evidence of an active infection during the Screening
    Period.
    14. The subject has evidence of, or treatment for, C. difficile infection or
    other intestinal pathogen with 28 days prior to first dose of study drug.
    15. The subject has chronic hepatitis B virus (HBV) or hepatitis C virus
    (HCV) infection.
    16. The subject has active or latent TB, regardless of treatment history,
    as evidenced by any of the following:
    17. The subject has any identified congenital or acquired
    immunodeficiency (eg, common variable immunodeficiency, human
    immunodeficiency virus [HIV] infection, organ transplantation).
    18. The subject has received any live vaccinations within 30 days prior to
    screening.
    19. The subject has clinically significant infection (eg, pneumonia,
    pyelonephritis) within 30 days prior to screening, or ongoing chronic
    infection.
    1.Il soggetto mostra qualsiasi evidenza di infezione attiva durante lo screening
    2.Soggetto che è stato sottoposto a resezione estesa del colon, colectomia subtotale o colectomia totale
    3.Il soggetto presenta anamnesi di >3 resezioni dell’intestino tenue o diagnosi di sindrome dell’intestino corto.
    4.Il soggetto ha ricevuto alimentazione enterale, diete definite in formula o alimentazione per via parenterale nei 21 giorni precedenti la somministrazione della prima dose di farmaco dello studio.
    5.Il soggetto ha l'ileostomia, colostomia o stenosi sintomatica fissa nota dell’intestino.
    6.Il soggetto ha ricevuto qualsiasi terapia non biologica sperimentale o approvata (ad es., ciclosporina, tacrolimus, talidomide, metotrexato o tofacitinib ad eccezione di quelli specificamente elencati nel protocollo) per il trattamento di malattia sottostante entro 30 giorni o 5 emivite precedenti lo screening (a seconda di quale sia il periodo più lungo).
    7.Il soggetto ha ricevuto qualsiasi agente biologico o biosimilare sperimentale o approvato nei 60 giorni o nelle 5 emivite precedenti lo screening, a seconda di quale sia il periodo più lungo.
    8.Il soggetto ha usato un trattamento topico (rettale) a base di acido 5 aminosalicilico (5-ASA) o corticosteroidi somministrati tramite clistere/supposta entro 2 settimane dalla somministrazione della prima dose di farmaco dello studio.
    9.Il soggetto necessita attualmente o si prevede che necessiterà di un intervento chirurgico per la malattia di Crohn (Crohn’s Disease, CD) durante lo studio.
    10.Il soggetto presenta una anamnesi o evidenze di polipi adenomatosi del colon che non sono stati rimossi.
    11.Il soggetto presenta una anamnesi o evidenze di displasia della mucosa del colon.
    12.Il soggetto presenta una diagnosi sospetta o confermata di colite ulcerosa, colite indeterminata, colite ischemica, colite da radiazioni, colite associata a malattia diverticolare o colite microscopica.
    13.Il soggetto presenta evidenze di infezione attiva durante il Periodo di screening.
    14.Il soggetto presenta evidenze di, o trattamento per, infezione da C. difficile o altro patogeno intestinale nei 28 giorni precedenti la prima dose di farmaco dello studio.
    15.Il soggetto è affetto da infezione da virus dell’epatite B* (Hepatitis B Virus, HBV) cronica o virus dell’epatite C (Hepatitis C Virus, HCV).
    * soggetti HBV immuni (ovvero, essendo negativi all’antigene di superficie dell’epatite B [HBsAb] e positivi all’anticorpo dell’epatite B) possono, comunque, essere inclusi.
    16.Il soggetto presenta tubercolosi (TB) attiva o latente, indipendentemente dallo storico del trattamento, come evidenziato da uno qualsiasi dei seguenti:
    17.Il soggetto presenta una qualsiasi immunodeficienza identificata congenita o acquisita (ad es., immunodeficienza comune variabile, infezione da virus dell’immunodeficienza umana (HIV), trapianto d’organo).
    18.Il soggetto ha ricevuto un qualsiasi vaccino vivo nei 30 giorni precedenti lo screening.
    19.Il soggetto presenta un’infezione clinicamente significativa (ad es. polmonite, pielonefrite) nei 30 giorni precedenti lo screening o infezione cronica in corso.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects with clinical remission, defined as Crohn's Disease Activity Index (CDAI) score =150, at Week 52.
    • Proporzione di soggetti con remissione clinica, definita come un punteggio dell’indice di attività della malattia di Crohn (CDAI) =150, alla Settimana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    -Proportion of subjects with enhanced clinical response, defined as a = 100 point decrease in CDAI score from Baseline (Week 0), at Week 52.
    -Proportion of subjects with corticosteroid-free remission, defined as subjects using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52.
    -Proportion of TNF-alpha antagonist naive subjects who achieved clinical remission, defined as CDAI score =150, at Week 52
    -Proporzione di soggetti con una risposta clinica potenziata, definita come una diminuzione =100 punti del punteggio CDAI rispetto al basale (Settimana 0), alla Settimana 52.
    -Proporzione di soggetti con remissione senza corticosteroidi, definita come soggetti che utilizzano corticosteroidi orali al basale (Settimana 0) che hanno interrotto i corticosteroidi orali e sono in remissione clinica alla Settimana 52.
    -Proporzione di soggetti naive di antagonisti del TNF-alfa che hanno ottenuto remissione clinica, definita come punteggio CDAI =150, alla settimana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA135
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Czechia
    Denmark
    Estonia
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    End of trial will be the date of the last visit of the last subject at the Week 68 Follow-up visit
    La fine della sperimentazione sarà la data dell'ultima visita dell'ultimo soggetto alla Visita di follow-up alla Settimana 68.
    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 months9
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days9
    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: 799
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 308
    F.4.2.2In the whole clinical trial 824
    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)
    Eligible subjects will be enrolled into an open-label extension (OLE) study and receive Vedolizumab SC treatment. This includes subjects who enter the Maintenance Period (clinical response at Week 6), plus subjects achieving a response by Week 14 who do not enter the Maintenance Period.
    The study medication will not be available to subjects not participating in the OLE trial or who are discontinued. The subject should be returned to the care of a physician and standard therapies as required.
    I soggetti idonei saranno arruolati in studio estensione in aperto (OLE) e riceveranno il tratt con Vedolizumab SC. Qs include soggetti che entrano in Periodo di mantenimento (risposta clinica a Sett 6), più sogg che ottengono risposta entro Sett 14 che non entrano nel Periodo di mantenimento. Farmaco di studio non sarà dispo per sogg che nn partecipano a sper OLE o che si sono ritirati. Il soggetto deve tornare alle cure di un medico e alle terapie standard in base alle necessità.
    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 Decision2016-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
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