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    Summary
    EudraCT Number:2015-001758-14
    Sponsor's Protocol Code Number:201677
    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:2021-01-20
    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 number2015-001758-14
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled,
    Parallel Group Study to Evaluate the Efficacy and Safety of
    Sirukumab in the Treatment of Patients with Giant Cell Arteritis
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di sirukumab nel trattamento di pazienti con arterite a cellule giganti
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of Sirukumab in the treatment of
    patients with Giant Cell Arteritis, using multiple sites, and an untreated
    patient group
    Studio per valutare l’efficacia e la sicurezza di sirukumab nel trattamento di pazienti con arterite a cellule giganti usando diversi centri e un gruppo di pazienti non trattati
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number201677
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    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 supportGlaxoSmithKline Research and Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road
    B.5.3.2Town/ cityStockley Park West, Uxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00448007839733
    B.5.5Fax number00000000000000
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 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 nameSirukumab
    D.3.2Product code GSK2973327
    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 INNSirukumab
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codeGSK2973327
    D.3.9.3Other descriptive nameCNTO 136
    D.3.9.4EV Substance CodeSUB26726
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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.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 nameSirukumab
    D.3.2Product code GSK2973327
    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 INNSirukumab
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codeGSK2973327
    D.3.9.4EV Substance CodeSUB26726
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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.IMP: 3
    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 Capsule di prednisone
    D.2.1.1.2Name of the Marketing Authorisation holderJubilant Cadista Pharmaceuticals Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor code00-00-0
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 4
    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 Prednisone Capsule
    D.2.1.1.2Name of the Marketing Authorisation holderJubilant Cadista Pharmaceuticals Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codePrednisone
    D.3.9.3Other descriptive nameOver encapsulated prednisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 5
    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 Prednisone capsule
    D.2.1.1.2Name of the Marketing Authorisation holderJubilant Cadista Pharmaceuticals Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codePrednisone
    D.3.9.3Other descriptive namePrednisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 6
    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 Encorton
    D.2.1.1.2Name of the Marketing Authorisation holderPabianickie Zaklady Farmaceutyczne Polfa S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codePrednisone
    D.3.9.3Other descriptive namePrednisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 7
    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 Encorton
    D.2.1.1.2Name of the Marketing Authorisation holderPabianickie Zaklady Farmaceutyczne Polfa S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codePREDNISONE
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Giant Cell Arteritis (GCA)
    Arterite a cellule giganti (Giant Cell Arteritis, GCA)
    E.1.1.1Medical condition in easily understood language
    Giant cell arteritis (GCA) is a condition in which medium and large
    arteries, usually in the head and neck, become inflamed.
    L’arterite a cellule giganti (GCA) è una malattia in cui le arterie di medie e grandi dimensioni, solitamente a livello di testa e collo, sviluppano un’infiammazione.
    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 SOC
    E.1.2Classification code 10047065
    E.1.2Term Vascular disorders
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of sirukumab (100 mg q2w for 12 months) as
    compared to placebo, each
    administered in addition to a 6-month prednisone treatment regimen
    Studiare l’efficacia di sirukumab (100 mg ogni 2 settimane [q2s] per 12 mesi) rispetto al placebo, ciascuno somministrato in aggiunta a un regime di trattamento con prednisone di 6 mesi
    E.2.2Secondary objectives of the trial
    1. To assess cumulative prednisone doses in subjects treated with
    sirukumab plus prednisone as compared to placebo plus prednisone
    2. To investigate the efficacy of Sirukumab (100 mg q2w for 12 months)
    with 3-month prednisone treatment versus placebo with a 6-month
    prednisone treatment
    3. To investigate the efficacy of sirukumab (100 mg q2w for 12 months)
    with a 6-month prednisone treatment as compared to placebo with a 12-
    month prednisone treatment
    4. To investigate the efficacy of sirukumab (100 mg q2w for 12 months)
    with a 3-month prednisone treatment versus placebo with a 12-month
    prednisone treatment
    5. To investigate the efficacy of sirukumab (50 mg q4w for 12 months)
    as compared to placebo, each
    administered in addition to a 6-month prednisone treatment
    6. To investigate the efficacy of Sirukumab (50 mg q4w for 12 months)
    with a 6-month prednisone treatment as compared to placebo with a 12-
    month prednisone
    1. Valutare le dosi cumulative di prednisone in soggetti trattati con sirukumab più prednisone, rispetto al placebo più prednisone
    2. Studiare l’efficacia di sirukumab (100 mg ogni 2 settimane [q2s] per 12 mesi) con un trattamento con prednisone di 3 mesi, rispetto al placebo con un trattamento con prednisone di 6 mesi
    3. Studiare l’efficacia di sirukumab (100 mg ogni 2 settimane [q2s] per 12 mesi) con un trattamento con prednisone di 6 mesi, rispetto al placebo con un trattamento con prednisone di 12 mesi
    4. Studiare l’efficacia di sirukumab (100 mg ogni 2 settimane [q2s] per 12 mesi) con un trattamento con prednisone di 3 mesi, rispetto al placebo con un trattamento con prednisone di 12 mesi
    5. Studiare l’efficacia di sirukumab (50 mg ogni 4 settimane [q4s] per 12 mesi)
    rispetto al placebo, ciascuno
    somministrato in aggiunta a un trattamento con prednisone di 6 mesi
    6. Studiare l’efficacia di sirukumab (50 mg ogni 4 sett [q4s] per 12 mesi) con un tratt con prednisone di 12 mesi
    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: A study to assess the utility of ultrasound imaging in monitoring disease activity in GCA in a cohort of subjects with new onset GCA.
    Objectives:
    1. To explore the utility of vascular ultrasound (US) imaging assessment of infiammation in temporal and axillary arteries as an indicator of disease activity in a cohort of study subjects.
    2. To explore the predictive value of ultrasound for clinical efficacy GCA.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Studio per valutare l’utilità della diagnostica per immagini tramite ecografia nel monitoraggio dell’attività della malattia nella GCA in una coorte di pazienti con una nuova insorgenza di GCA.
    Obiettivi:
    1. Esplorare l’utilità della valutazione dell’infiammazione nelle arterie temporali e ascellari tramite diagnostica per immagini ecografica come indicatore dell’attività della malattia in una coorte di soggetti dello studio.
    2. Esplorare il valore predittivo degli ultrasuoni per l’efficacia clinica nella GCA
    E.3Principal inclusion criteria
    1.Diagnosis of GCA defined by the following Revised GCA Diagnosis
    Criteria:
    •Age =50 years.
    •History of ESR = 50 mm/hour or CRP = 2.45 mg/dL.
    •Presence of at least one of the following:
    oUnequivocal cranial symptoms of GCA (new onset localized headache,
    scalp or temporal artery tenderness, ischemia-related vision loss, or
    otherwise
    unexplained mouth or jaw pain upon mastication).
    oUnequivocal symptoms of PMR, defined as shoulder and/or hip girdle
    pain associated with inflammatory stiffness.
    •Presence of at least one of the following:
    oTemporal artery abnormality on biopsy revealing features of GCA.
    oEvidence of large-vessel vasculitis by angiography or cross-sectional
    imaging, including but not limited to magnetic resonance angiography
    (MRA), computed tomography angiography (CTA), ultra sound (US) or
    positron emission
    tomography-computed tomography (PET-CT).
    o Evidence of temporal artery vasculitis on US (for US imaging qualified centres only)
    2.Active GCA within 6 weeks of Randomization (Baseline) where active
    disease is
    defined by an ESR = 30 mm/hr or CRP = 1 mg/dL AND the presence of at
    least one of the following:
    • • Unequivocal cranial signs and symptoms of GCA (new onset localized
    headache, scalp or temporal artery tenderness, reduced or absent
    pulsation in temporal artery, stroke, scalp necrosis, pain over face/scalp
    arteries or otherwise unexplained mouth or jaw pain upon mastication
    [i.e., jaw claudication]).
    • Visual signs and symptoms associated with GCA, including ischemiarelated
    vision loss [permanent vision loss due to AION, amaurosis fugax,
    episodic blurry vision], diplopia, scotoma nerve palsies, relative afferent
    papillary defects, central retinal artery occlusions.
    •Unequivocal symptoms of PMR, defined as shoulder and/or hip girdle
    pain associated with inflammatory stiffness.
    •Other features judged by the clinician investigator to be consistent with
    GCA or PMR flares (i.e., new or worsened extremity claudication, fever of
    unknown
    origin).
    3.At screening, receiving or able to initiate prednisone treatment with a minimum dose of 20 mg/day for
    the treatment of active GCA.
    4.Clinically stable GCA disease at baseline such that the subject is able to
    safely participate in the blinded prednisone taper regimen in the opinion
    of the investigator.
    5.Practicing acceptable methods of birth control if a female of childbearing
    potential.
    6.No evidence of active or latent infection with Mycobacterium
    tuberculosis (TB), as defined by all of the following:
    •No history of active or latent TB infection.
    •A negative diagnostic TB test at Screening defined as a negative QuantiFERON Gold test or T-spot test (performed locally)
    (NB: 2 successive indeterminate QuantiFERON tests will be considered as a positive result).
    •Chest radiograph (both posterior-anterior and lateral views unless local guidelines recommend only a single view), taken
    within 12 weeks prior to baseline or at Screening, and read locally by a
    qualified radiologist, with no evidence of current active or previous
    inactive pulmonary tuberculosis.
    NB: If there has been recent close contact with persons who have active
    TB prior to study enrolment the subject will be referred to a TB physician to undergo additional evaluation.
    1. Diagnosi di GCA definita in base ai seguenti criteri di diagnosi di GCA
    rivista:
    •Età =50 anni.
    •Anamnesi di VES =50 mm/ora oppure PCR =2,45 mg/dl.
    •Presenza di almeno uno dei seguenti:
    o sintomi inequivocabili di GCA a livello cranico (cefalea localizzata di nuova insorgenza, iperestesia del cuoio capelluto o dell’arteria temporale, perdita della vista correlata a ischemia oppure
    dolore inspiegato alla bocca o alla mascella durante la masticazione).
    o sintomi inequivocabili di polimialgia reumatica (polymyalgia rheumatica, PMR), definita come dolore alla spalla e/o al cingolo pelvico associato a rigidità infiammatoria.
    •Presenza di almeno uno dei seguenti:
    oAnomalia dell’arteria temporale riscontrata durante la biopsia che rivela caratteristiche tipiche dell’arterite a cellule giganti (giant cell arteritis, GCA).
    oEvidenza di vasculite dei grandi vasi mediante angiografia oppure esame radiologico trasversale, tra cui, senza limitazioni, angiografia a risonanza magnetica (angio RM), angiografia a tomografia computerizzata (angio TAC), ultrasuoni (US), tomografia ad emissione di positroni-tomografia computerizzata (PET-TAC)
    o Evidenza di vasculite dei grandi vasi o dell’arteria temporale tramite US (diagnostica per immagini con US unicamente nei centri qualificati).
    2. GCA attiva entro 6 settimane dalla randomizzazione (basale), dove la malattia attiva è
    definita come VES =30 mm/hr o PCR 1 mg/dl E presenza di almeno uno dei seguenti:
    Segni e sintomi inequivocabili di GCA a livello cranico (cefalea localizzata di nuova insorgenza, iperestesia del cuoio capelluto o dell’arteria temporale, pulsazioni ridotte o assenti a livello dell’arteria temporale, ictus, necrosi del cuoio capelluto, dolore in prossimità delle arterie del volto/cuoio capelluto o altrimenti dolore inspiegabile alla bocca o alla mandibola durante la masticazione [ossia, claudicatio della mandibola]).
    • Segni e sintomi visivi associati alla GCA, inclusa la perdita della vista correlata a ischemia [perdita permanente della vista dovuta a neuropatia ottica ischemica anteriore (anterior ischemic optic neuropathy, AION), amaurosi fugace, visione offuscata episodica], diplopia, paralisi del nervo che provocano scotomi, difetti papillari afferenti correlati, occlusioni delle arterie retiniche centrali.
    • Sintomi inequivocabili di PMR, definita come dolore alla spalla e/o al cingolo pelvico associato a rigidità infiammatoria.
    • Altre caratteristiche giudicate dallo sperimentatore clinico in linea con la GCA o riacutizzazioni di PMR (ovvero peggioramento o nuova insorgenza di claudicazione delle estremità, febbre di origine
    ignota).
    3. Allo screening, assunzione o possibilità di iniziare ad assumere prednisone ad una dose minima di 20 mg/die per il trattamento della GCA attiva.
    4. GCA clinicamente stabile al basale, in modo tale che il soggetto sia in grado di partecipare in sicurezza al regime di riduzione di prednisone in cieco, secondo il parere dello sperimentatore.
    5. Utilizzo di metodi contraccettivi accettabili per i soggetti femminili potenzialmente fertili.
    6. Nessuna evidenza di infezione attiva o latente da micobatterio della tubercolosi (TB), come indicato qui di seguito:
    •Nessuna anamnesi di infezione da TB attiva o latente.
    •Risultato negativo al test diagnostico per la TB allo screening, definito come:
    o Risultato negativo al test QuantiFERON Gold o T-spot (eseguito localmente) (NB: 2 risultati indeterminati consecutivi ai test QuantiFERON saranno considerati un risultato
    positivo).
    •Radiografia toracica (viste posteriore-anteriore e laterali salvo qualora le linee guida loc raccomandano solo una proiezione), eseguita entro le 12 settimane precedenti il basale o allo screening e letta localmente da un radiologo qualificato, con nessuna evidenza di tubercolosi polmonare attualmente attiva o precedentemente inattiva.
    NB: in caso di recente stretto contatto con persone che presentano TB attiva prima dell’arruolamento nello studio, il soggetto sarà indirizzato a un medico specializzato in TB per sottoporsi a ulteriori valutazioni.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the
    following criteria apply:
    1. Are pregnant or breastfeeding.
    2. Recent (within the past 12 weeks) or planned major surgery that
    would impact on study procedures or assessments.
    3. Organ transplantation recipients (except corneas within 3 months
    prior to baseline visit).
    4. Had prior treatment with any of the following:
    •Systemic immunosuppressives, including azathioprine, oral
    cyclosporine A,tacrolimus, mycophenolate mofetil, leflunomide, oral or
    parenteral gold, and IL-1ra (anakinra) within 4 weeks of baseline.
    •Biologic agents targeted at reducing TNF (including but not limited to
    infliximab, golimumab, certolizumab pegol, etanercept, yisaipu, and
    adalimumab)within 4-8 weeks of baseline, depending on the agent*.
    •Any prior use of tocilizumab or other anti-IL-6 agents.
    B-cell depleting agents (eg, rituximab) within 12 months prior to
    baseline or longer if B cell counts have not returned to normal range or
    baseline levels
    Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen
    mustard, or other alkylating agents within 4 weeks of baseline.
    •Abatacept within 8 weeks of baseline.
    •Tofacitinib within 4 weeks of baseline.
    •Methotrexate use within 2 weeks of baseline.
    •Methylprednisolone > 100 mg/day IV (or equivalent) within 8 weeks of
    baseline.
    5. Regular or continuous systemic corticosteroid use for > 4 years.
    6. Requires continued or repeated use of systemic corticosteroids for
    conditions other than GCA.
    7. History of severe allergic reactions to monoclonal antibodies, human
    proteins, or excipients.
    8. Evidence of serious concomitant disease, which in the opinion of the
    investigator makes them unsuitable for participation in the study.
    9. Major ischemic event, unrelated to giant cell arteritis, within 12 weeks
    of screening.
    10. Marked baseline prolongation of QTc interval = 450 msec (QTcB or
    QTcF), history of Torsade de Pointes, family history of long QT syndrome,
    history of second or third degree heart block.
    11. Current liver disease that could interfere with the trial as determined
    by the physician investigator.
    12. History of or current active diverticulitis, inflammatory bowel
    disease, or other symptomatic GI tract condition that might predispose
    to bowel perforation.
    13. History of known demyelinating diseases such as multiple sclerosis
    or optic neuritis.
    14. Active infections, or history of recurrent infections or have required
    management of acute or chronic infections, as follows:
    •Currently on any suppressive therapy for a chronic infection (such as
    tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus,
    herpes zoster and atypical mycobacteria,
    •History or suspicion of chronic infection (e.g joint infection).
    OR
    •Hospitalization for treatment of infection within 60 days of the baseline
    visit.
    OR
    •Use of parenteral (IV or IM) antimicrobials (antibacterials, antivirals,
    antifungals, or antiparasitic agents) within 60 days of baseline or oral
    antimicrobials within 30 days of baseline.
    15.Primary or secondary immunodeficiency.
    16.HIV infection (positive serology for HIV antibody), hepatitis C
    (positive serology
    for hepatitis C antibody)**.
    17.Hepatitis B infection (positive test results for hepatitis B surface
    antigen or hepatitis
    B core antibody).
    18.Active malignancy or history of malignancy within previous 5 years
    (except basal and squamous cell carcinoma of the skin or carcinoma in
    situ of the cervix uteri that has been excised and cured).
    19.Laboratory abnormalities:
    •AST or ALT >2.0 × upper limit of normal (ULN).
    •Total bilirubin >ULN with the exception of Gilbert's disease.
    •Platelet count <140 × 109/L.
    •Hemoglobin <8.5 g/dL.
    •WBC count <3.5 × 109/L.
    •ANC <2 × 109/L.
    •ALC <0.5 × 109/L.
    •Serum creatinine = 2.0 mg/dL (SI: positive = 177 µmol/L).
    20. Has received, or is expected to receive, any live virus or bacterial
    vaccination within 3 months before the first administration of study
    drug, during the study, or within 4 months after the last administration
    of study drug.
    21. Any other autoimmune disease (such as SLE, RA, inflammatory
    arthritis, other vasculitides, scleroderma, polymyositis, dermatomyositis
    or other similar systemic connective tissue diseases).
    22. Uncontrolled psychiatric or emotional disorder, drug abuse, alcohol
    abuse within past 3 years.
    *Please refer to the Study Procedures Manual (SPM) for guidance.
    ** If seropositive, consultation with a physician with expertise in the
    treatment of HIV or hepatitis B or C virus infection is recommended.
    Un sogg risulterà non idoneo all’inclus in questo studio se soddisfa uno qualsiasi dei seguenti criteri: 1. Ess in gravid o allattamento.
    2. Intervento di chirurgia maggiore recente (eseg nell’arco delle ultime 12 settim) o program che avrebbe un impatto sulle proced o sulle valutaz dello studio.
    3. Riceventi trapianto d’organo (fatta eccezione per le cornee entro i 3 mesi precedenti la visita basale).
    4. Preced trattam con uno dei seguenti:
    •Immunosoppressivi sistemici, tra cui azatioprina, ciclosporina A per via orale, tacrolimus, mofetil micofenolato, leflunomide, oro per via orale o parenterale e IL-1ra (anakinra) entro 4 settim dal basale. •Agenti biologici volti alla riduz del TNF (inclusi, senza limitazioni, infliximab, golimumab, certolizumab pegolo, etanercept, yisaipu e adalimumab) entro 4-8 settim dal basale, a seconda dell’agente*.
    •Eventuale pregresso impiego di tocilizumab o altri agenti anti IL-6. Agenti riducenti i linfociti B (ad es. rituximab) nei 12 mesi precedenti al basale o per un tempo più lungo se la conta dei linfociti B non è tornata nella norma o ai livelli del basale. Farmaci citotossici, come ciclofosfamide, clorambucile, iprite azotata o altri agenti alchilanti nelle 4 settim preced il basale.
    •Abatacept entro 8 sett dal basale.
    •Tofacitinib entro 4 sett dal basale.
    •Metotressato entro 2 sett dal basale.
    •Metilprednisolone >100 mg/die per via EV (o equivalente) entro 8 sett dal basale.
    5. Utilizzo regolare e continuativo di corticosteroidi sistemici per > 4 anni.
    6. Richiede un utilizzo continuativo o ripetuto di corticosteroidi sistemici per condizioni diverse dalla GCA.
    7. Anamnesi di gravi reazioni allergiche agli anticorpi monoclonali, alle proteine umane o agli eccipienti.
    8. Evidenza di grave malattia concomitante, che, a giudizio dello sperimentat, rende il sogg non idoneo alla partecipaz allo studio.
    9. Evento ischemico maggiore, non correlato all’arterite a cellule giganti, entro 12 settimane dallo screening.
    10. Marcato prolungamento dell’intervallo QTc al basale =450 msec. (QTcB o QTcF), anamnesi di torsione di punta, anamnesi familiare di sindrome del QT lungo, anamnesi di arresto cardiaco di secondo o terzo grado.
    11. Attuale epatopatia che può interferire con la sperimentaz, come determinato dal medico sperimentat.
    12. Anamnesi di attuale diverticolite attiva, malattia infiamma intestinale o altra patologia sintomatica del tratto gastrointestinale (GI) che può predisporre alla perforazione intestinale.
    13. Anamnesi di note malattie demielinizzanti, come sclerosi multipla o neurite ottica.
    14. Infezioni attive o anamnesi di infezioni ricorrenti o infez acute o croniche per cui sia stato necess un trattam, come indicato di seguito:
    •Qualsiasi terapia immunosoppressiva attualmente in corso per un’infezione cronica (come tubercolosi, pneumocisti, citomegalovirus, virus dell’herpes simplex, herpes zoster e micobatteri atipici.
    •Anamnesi o sospetto di infez cronica (ad esempio infezione articolare). OPPURE
    •Ricovero ospedal per il trattam di un’infezione entro 60 giorni dalla visita basale.
    OPPURE
    •Uso di antimicrobici per via parenterale (EV o IM) (agenti antibatterici, antivirali, antimicotici o antiparassitari) entro 60 giorni dal basale oppure antimicrobici orali entro 30 giorni dal basale.
    15. Immunodeficienze primarie o secondarie.
    16. Infezione da HIV (sierologia positiva per gli anticorpi dell’HIV), epatite C (sierologia positiva
    per gli anticorpi dell’epatite C)**.
    17. Infezione da epatite B (risultati positivi al test per l’antigene di superficie dell’epatite B o l’anticorpo
    core dell’epatite B).
    18. Tumore maligno attivo o anamnesi di tumore maligno nei 5 anni precedenti
    (ad eccezi del carcinoma a cellule basali e squamose della cute o del carcinoma in situ della cervice uterina sottoposto a escissione e curato).
    19. Anomalie di laboratorio:
    •AST o ALT >2,0 × limite superiore della norma (upper limit of normal, ULN).
    •Bilirubina totale >ULN, ad eccezione della sindrome di Gilbert.
    •Conta piastrinica <140 × 109/l.
    •Emoglobina <8,5 g/dl.
    •Conta dei leucociti <3,5 × 109/l.
    •ANC <2 × 109/l.
    •ALC <0,5 × 109/l.
    •Creatinina sierica =2,0 mg/dl (SI: positivo =177 µmol/l).
    20. Somministraz pregressa o program di qualsiasi vaccino vivo costituito da batterio o virus nei 3 mesi prec la prima somminis del farmaco in studio, durante lo studio o nei 4 mesi succ all’ultima somministraz del farmaco in studio.
    21. Qualsiasi altra malattia autoimmune (come lupus eritematoso sistemico [LES], artrite reumatoide [AR], artrite infiammatoria, altre vasculiti, sclerodermia, polimiosite, dermatomiosite o altre simili patologie sistemiche del tessuto connettivo).
    22. Disturbo psichiatrico o emotivo non controllato, abuso di sostanze, abuso di alcol negli ultimi 3 anni.
    *Fare riferim al manuale delle proced dello studio (Study Proced Manual, SPM) per ulter indicaz.
    ** In caso di sieropositività, si consiglia di consult un medico con esp HIV o epat B o C
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects in sustained remission at Week 52
    Percentuale di soggetti in remissione sostenuta alla Settimana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    -
    -
    E.5.2Secondary end point(s)
    Part A: 52-week double blind treatment phase
    •Median and cumulative prednisone dose over time
    •Proportion of subjects in sustained remission at each time point of
    assessment from week 12 to week 52
    •Proportion of subjects in remission over time
    •Time to first GCA flare after clinical remission
    •Number of disease flares per patient over time
    •Proportion of subjects requiring hospitalizations for disease flare and
    number of hospitalizations for disease flare
    •Incidence of adverse events and serious adverse events, incidence of
    corticosteroid-related adverse events, changes in vital signs, hematology
    and
    clinical chemistry parameters
    •Patient and clinician reported outcomes including SF-36v2, EQ-5D (5L),
    FACITFatigue, Pain NRS, Steroid Impact PRO, HAQ-DI, PGIC, PtGA, PhGA
    •Change from baseline in ESR over time
    •Change from baseline in serum CRP over time
    •Serum concentrations of sirukumab
    •Serum anti-sirukumab antibodies
    •Change from baseline in IFN-¿ and IL-17A
    •Change from baseline in serum markers of bone formation/resorption:
    CTX1/P1NP
    •Correlation of genetic markers with the safety and efficacy response to
    sirukumab
    Parte A: Fase di trattamento in doppio cieco di 52 settimane
    •Dose media e cumulativa di prednisone nel tempo
    •Percentuale di soggetti in remissione sostenuta in occasione di ciascun momento di valutazione dalla Settimana 12 alla Settimana 52
    •Percentuale di soggetti in remissione nel tempo
    •Tempo trascorso fino alla prima riacutizzazione della GCA dopo la remissione clinica
    •Numero di riacutizzazioni della malattia per paziente nel tempo
    •Percentuale di soggetti che necessitano di ricoveri per la riacutizzazione della malattia e numero di ricoveri per la riacutizzazione della malattia
    •Incidenza di eventi avversi ed eventi avversi gravi, incidenza di eventi avversi correlati ai corticosteroidi, variazioni nei segni vitali, nei parametri ematologici
    ed ematochimici
    •Esito riferito dal paziente e dal medico, tra cui la versione 2 del questionario breve a 16 item sulla qualità di vita (36-item short-form questionnaire – version 2, SF-36v2), il questionario europeo sulla qualità di vita (EuroQol) a 5 livelli e 5 dimensioni (five-level EuroQol five-dimensional questionnaire, EQ-5D [5L]), la scala di valutazione funzionale della terapia per malattie croniche correlata all’affaticamento (Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-Fatigue), la scala di valutazione numerica (numerical rating scale, NRS) del dolore, l’esito riferito dal paziente (patient reported outcome, PRO) correlati all’impatto degli steroidi, l’indice di disabilità mediante questionario di valutazione della salute (health assessment questionnaire-disability index, HAQ-DI), l’impressione globale del cambiamento del paziente (patient global impression of change, PGIC), la valutazione globale del paziente dell’attività della malattia (patient global assessment of disease activity, PtGA) e la valutazione globale del medico dell’attività della malattia (physician global assessment of disease activity, PhGA)
    •Variazione rispetto al basale della VES nel tempo
    •Variazione rispetto al basale dei livelli sierici di proteina C reattiva (PCR) nel tempo
    •Concentrazioni sieriche di sirukumab
    •Anticorpi sierici anti-sirukumab
    •Variazione rispetto al basale nell’interferone gamma (IFN-¿) e nell’interleuchina 17A (IL-17A).
    •Variazione rispetto al basale nei marcatori sierici di formazione ossea/riassorbimento osseo: CTX1/P1NP
    •Correlazione tra i marcatori genetici e la risposta di sicurezza ed efficacia di sirukumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week -6, 0, 2, 4, then every 4 weeks to week 52
    Settimane -6, 0, 2, 4, quindi ogni 4 settimane fino alla 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Australia
    New Zealand
    United States
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 173
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 204
    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)
    Upon study completion, decisions on treatment options for individual
    subjects will be at
    the discretion of the investigator.
    Una volta terminato lo studio, le decisioni sulle opzioni terapeutiche per i singoli soggetti saranno prese a discrezione dello sperimentatore.
    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 Decision2016-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-20
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