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    Summary
    EudraCT Number:2014-003453-34
    Sponsor's Protocol Code Number:201755
    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:2021-01-19
    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 number2014-003453-34
    A.3Full title of the trial
    A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.
    Studio di fase IIb, in doppio cieco, controllato con placebo, con aggiustamento della dose, sull'efficacia e la sicurezza di GSK3196165 in associazione alla terapia con metotressato, in soggetti affetti da artrite reumatoide attiva da moderata a grave nonostante il trattamento con metotressato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate
    Studio sull'efficacia di un nuovo farmaco in persone con artrite reumatoide che non hanno risposto sufficientemente bene al trattamento con metotressato
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number201755
    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 & 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 & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Rd
    B.5.3.2Town/ cityStockley Park West, Uxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 208 990 4466
    B.5.5Fax number+44 208 990 4968
    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.3.2Product code GSK3196165
    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.3.9.1CAS number 1638332-55-4
    D.3.9.2Current sponsor codeGSK3196165
    D.3.9.3Other descriptive nameAnticorpo monoclonale anti GM-CSF umano
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Rheumatoid Arthritis
    Artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis (RA) is a chronic, systemic inflammatory autoimmune disease, characterised by a symmetrical polyarthritis that is associated with substantial disability and morbidity
    L'artrite reumatoide (AR) ¿ una malattia infiammatoria cronica, sistemica e autoimmune, caratterizzata da una poliartrite asimmetrica associata a considerevole disabilit¿ e morbilit¿
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of GSK3196165
    Valutare l'efficacia di GSK3196165
    E.2.2Secondary objectives of the trial
    To assess:
    - Dose-efficacy response of GSK3196165
    - Safety
    - Population pharmacokinetics
    - Pharmacodynamics
    - Novel biomarkers: To examine the molecular profiles of blood samples to identify factors that may influence biological and clinical responses to GSK3196165 and/or associated with the development
    or progression of RA or medically related
    conditions
    Valutare:
    - risposta dose-efficacia di GSK3196165
    - sicurezza
    - farmacocinetica della popolazione
    - farmacodinamica
    - biomarcatori innovativi: esaminare i profili molecolari di campioni ematici al fine di identificare fattori in grado di influenzare le risposte biologiche e cliniche a GSK3196165 e/o associati allo sviluppo o alla progressione dell'AR o di condizioni clinicamente correlate
    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: Actigraphy substudy
    To explore how actigraphy measurements of physical activity correlate to disease activity, the following measures will be explored as change
    over time and change from baseline:
    - Inter- and intra-daily measures of physical activity including but not limited to:
    - Time spent sedentary (sitting and lying), time spent active (walking and standing), total activity score (function of duration and intensity of activity), number and duration of continuous walking periods
    - Duration of morning stiffness
    - Measures of sleep quality including but not be limited to:
    - Time lying, number of movement episodes, sleep efficiency (function of % of movement time and total % of lying time) and fragmentation index (function of movement time % andnumber of movement episodes)
    - RA Symptom and Impact diary

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio actigrafico
    Per esplorare come le misurazioni actigrafiche dell¿attivit¿ fisica siano in correlazione con l¿attivit¿ della malattia, verranno esplorate le seguenti misurazioni come cambiamento nel tempo e cambiamento dal basale:
    - Misurazioni inter-e intra-giornaliere dell¿attivit¿ fisica incluso ma non limitato a:
    - tempo speso in sedentariet¿ (seduto e sdraiato), tempo speso attivamente (camminata e in piedi), punteggio di attivit¿ totale (in funzione della durata e dell¿intensit¿ dell¿attivit¿), numero e durata dei periodi continui di camminata
    - durata della rigidit¿ mattutina
    - Misurazioni della qualit¿ del sonno, incluso ma non limitato a:
    - tempo dello stato sdraiato, numero di episodi di movimento, efficienza del sonno (funzione della % del tempo di movimento e della % del tempo totale dello stato sdraiato) e indice di frammentazione (funzione della percentuale del tempo di movimento e il numero di episodi di movimento)
    - Diario dei sintomi e degli impatti AR

    E.3Principal inclusion criteria
    1. Age =18 years at the time of signing informed consent.
    2. Meets ACR/EULAR 2010 RA Classification Criteria.
    3. Functional class I, II or III defined by the 1992 ACR Classification of Functional Status in RA.
    4. Disease duration of =12 weeks (time from onset of patient-reported symptoms of either pain or stiffness or swelling in hands, feet or wrists).
    5. Swollen joint count of =4 (66-joint count) and tender joint count of = 4 (68-joint count) at screening and at Day 1.
    6. DAS28(CRP) =3.2 at screening and DAS28(ESR) =3.2 at Day 1.
    7. C-Reactive Protein (CRP) =5.0 mg/L at screening.
    8. Must have previously received MTX (15-25 mg weekly) for at least 12 weeks before screening, with no change in route of administration, with
    a stable and tolerated dose for =4 weeks prior to Day 1. A stable dose of MTX =7.5 mg/week is acceptable, if the MTX dose has been reduced for
    reasons of documented intolerance to MTX, e.g. hepatic or hematologic toxicity, or per local requirement.
    9. Weight =45 kg.
    10. Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria detailed in Appendix 12.2.
    11. Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications.
    12. Willing to continue or initiate treatment with oral folic acid (at least 5 mg/week) or equivalent and be treated during the entire study (mandatory co-medication for MTX treatment).
    13. Diffusing capacity of the lung for carbon monoxide (DLCO) =60% (a,b) predicted; forced expiratory volume in 1 second (FEV1) =70%
    predicted.
    a. Screening and Day 1 values within 10% of each other (the test may be repeated twice within the screening period, i.e. subjects may undergo a total of three DLCO tests during the screening period).
    b. For subjects with DLCO values > 60% to <70%, a baseline chest HRCT must be performed during the screening period, and it is recommended that the subject be reviewed by a local pulmonologist to exclude significant preexisting respiratory disease.
    14. No evidence of active or latent infection with Mycobacterium tuberculosis (TB), as defined by all of the following:
    a. No history of active or latent TB infection irrespective of treatment status.
    b. A negative diagnostic TB test within 28 days of baseline (Day 1) defined as:
    i. A negative QuantiFERON Gold test or T-spot test (performed locally) (NB: 2 successive indeterminate QuantiFERON tests will be considered as a positive result).
    OR
    ii. If QuantiFERON gold or T-spot test not approved or registered in country of participation, then a negative tuberculin skin test (TST) reaction as per local guidelines is required (it is strongly recommended that subjects with a history of BCG vaccination be tested with QuantiFERON gold test).
    c. Chest X-ray within 12 weeks of Day 1, locally read by a radiologist, with no evidence of current or previous 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. Età =18 anni al momento di firmare il consenso informato.
    2. Soddisfa i criteri di classificazione AR 2010 di ACR/EULAR.
    3. Classe funzionale I, II o III, definita dalla Classificazione ACR dello stato funzionale nell'AR, 1992.
    4. Durata della malattia =12 settimane (tempo trascorso dalla comparsa dei sintomi di dolore, rigidità o tumefazione di mani, piedi o polsi segnalati dal paziente).
    5. Conteggio delle articolazioni tumefatte =4 (conteggio di 66 articolazioni) e conteggio delle articolazioni dolorabili =4 (conteggio di 68 articolazioni) allo screening e al giorno 1.
    6. DAS28(PCR) =3.2 allo screening e DAS28(VES) =3.2 al giorno 1.
    7. Proteina C-reattiva (PCR) =5.0mg/l allo screening.
    8. Il soggetto deve aver ricevuto una terapia precedente con MTX (15-25mg settimanalmente) per almeno 12 settimane prima dello screening, senza cambiare via di somministrazione, con una dose stabile e tollerata per =4 settimane prima del giorno 1. Una dose stabile di MTX =7.5mg/settimana è accettabile, se la dose di MTX è stata ridotta per motivi di intolleranza documentata a MTX, ad es. tossicità epatica o ematologica, o in conformità a un requisito locale.
    9. Peso =45kg.
    10. I soggetti maschili o femminili sono idonei a partecipare purché soddisfino e accettino di attenersi ai criteri di contraccezione specificati nell’Appendice 12.2
    11. Consenso informato scritto preliminare a qualsiasi procedura di screening, inclusa l'interruzione dei farmaci vietati.
    12. Disponibilità a continuare o iniziare il trattamento con acido folico per via orale (almeno 5mg/settimana) o equivalente e a ricevere il trattamento durante l'intero studio (somministrazione concomitante di farmaci obbligatoria durante il trattamento con MTX).
    13. Capacità di diffusione polmonare prevista per il monossido di carbonio (DLCO) =60%a,b; volume espiratorio forzato previsto, in 1 secondo (FEV1), =70%.
    a. Differenza inferiore al 10% tra i valori allo screening e al giorno 1 (è possibile ripetere il test due volte durante il periodo di screening, cioè i soggetti possono effettuare in totale tre esami DLCO durante il periodo di screening).
    b. Per i soggetti con valori di DLCO compresi tra il 60 e il 70%, durante il periodo di screening è necessario eseguire, al basale, una TC del torace ad alta risoluzione; inoltre si consiglia che tali soggetti vengano visitati da uno pneumologo locale al fine di escludere significative malattie respiratorie preesistenti.
    14. Nessuna evidenza di infezione attiva o latente da Mycobacterium tuberculosis (TB), secondo tutte le seguenti condizioni:
    a. Nessuna anamnesi di infezione da TB attiva o latente, indipendentemente dallo stato di trattamento.
    b. Un test diagnostico per TB negativo, nei 28 giorni precedenti il basale (giorno 1), definito come segue:
    i. Un test QuantiFERON Gold o un test T-spot negativo (eseguibili localmente) (NB: 2 test QuantiFERON indeterminati successivi verranno considerati come un risultato positivo).
    OPPURE
    ii. Se il test QuantiFERON Gold o T-spot non è approvato o registrato nel paese di partecipazione, è necessaria una reazione negativa al test cutaneo alla tubercolina (TST), in conformità alle linee guida locali (si consiglia caldamente di sottoporre al test QuantiFERON Gold i soggetti con una precedente vaccinazione BCG (Bacillo di Calmette-Guérin)).
    c. Radiografia del torace nelle 12 settimane precedenti al giorno 1, interpretata localmente da un radiologo, senza evidenza di tubercolosi polmonare attuale o precedente.
    NB: in caso di contatto diretto recente con persone affette da TB attiva prima dell'arruolamento nello studio, il soggetto verrà indirizzato a uno specialista in materia, per essere sottoposto ad ulteriore valutazione.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women.
    2. History of other inflammatory rheumatological or autoimmune disorders, other than Sjögren's syndrome secondary to RA.
    3. History of any respiratory disease which (in the opinion of the investigator) would compromise subject safety or the ability of the subject to complete the study (e.g. significant interstitial lung disease, such as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), moderate-severe asthma, bronchiectasis, previous PAP).
    4. Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained.
    5. QTc >450msec or QTc >480msec for subjects with bundle branch block.
    The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF).
    6. Liver function tests: alanine aminotransferase (ALT) >1.5x upper limit of normal (ULN); aspartate transaminase (AST) >1.5 upper limit of normal; alkaline phosphatase and bilirubin =1.5xULN (isolated bilirubin >1.5xULN is acceptable if
    bilirubin is fractionated and direct bilirubin <35%).
    7. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver
    disease per investigator assessment).
    8. Significant unstable or uncontrolled acute or chronic disease (e.g., cardiovascular including uncompensated congestive cardiac failure NYHA
    III or IV, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, uncontrolled hypercholesterolemia)
    pulmonary, hematologic, gastrointestinal (including Crohn's Disease or ulcerative colitis), hepatic, renal, neurological, psychiatric, malignancy,
    endocrinological or infectious diseases, which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
    9. A history of malignant neoplasm within the last 10 years or breast cancer within the last 20 years, except for non-melanoma skin cancers that have been excised and cured or carcinoma in situ of the uterine cervix.
    10. Kidney disease: Current or history of renal disease, or estimated creatinine clearance <60 mL/min/1.73m2 or serum creatinine >1.5xULN
    within 28 days of Day 1.
    11. Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.
    12. History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.
    13. Active infections, or history of recurrent infections (excluding recurrent fungal infections of the nail bed), or have required management of acute or chronic infections, as follows:
    a. Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
    OR
    b. Hospitalization for treatment of infection within 26 weeks of Day 1.
    OR
    c. Use of parenteral (IV or IM) antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) within 26 weeks of Day 1 or oral antimicrobials within 14 days of Day 1.
    14. A vaccination (live or attenuated) within 30 days of Day 1 or BCG vaccination within 365 days of Day 1, or a live vaccination planned during the course of the study.
    15. Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to Day 1 or any planned surgery within the duration of the study or follow-up period.
    16. For those subjects in the actigraphy substudy: wheelchair, walking aids, artificial limbs; history of severe skin allergy; active implantable device; pacemaker
    1. Donne gravide o in allattamento.
    2. Anamnesi di altre patologie infiammatorie, reumatiche o autoimmuni, tranne la sindrome di Sjögren secondaria ad AR.
    3. Anamnesi di malattia respiratoria che (secondo lo sperimentatore) comprometterebbe la sicurezza o la capacità del soggetto di completare lo studio (ad es. significativa malattia polmonare interstiziale, come fibrosi polmonare, broncopneumopatia cronica ostruttiva (BPCO), asma da moderata a grave, bronchiectasia, proteinosi alveolare polmonare precedente).
    4. Tosse o dispnea e anomalie respiratorie persistenti, di causa indeterminata, clinicamente significative o instabili (secondo lo sperimentatore).
    5. QT corretto >450msec o QT corretto >480msec per i soggetti con blocco di branca.
    Il QT corretto è l'intervallo QT corretto per la frequenza cardiaca secondo la formula di Fridericia (QT corretto F).
    6. Prove di funzionalità epatica: alanina amminotrasferasi (ALT) >1.5x limite superiore di normalità (ULN); aspartato transaminasi (AST) >1.5x limite superiore di normalità; fosfatasi alcalina e bilirubina =1.5x limite superiore di normalità (una concentrazione di bilirubina >1.5x limite superiore di normalità è accettabile se la biblirubina è frazionata e in presenza di una concentrazione di bilirubina diretta <35%).
    7. Attuale patologia epatica o biliare attiva (con l'eccezione della sindrome di Gilbert, dei calcoli biliari o di un'epatopatia cronica altrimenti stabile, secondo la valutazione dello sperimentatore).
    8. Significativa malattia acuta o cronica instabile o non controllata (ad es. cardiovascolare, inclusi insufficienza cardiaca congestizia scompensata NYHA III o IV, infarto miocardico entro 12 mesi, angina pectoris instabile, ipertensione non controllata, ipercolesterolemia non controllata) o malattie polmonari, ematologiche, gastrointestinali (incluso morbo di Crohn o colite ulcerosa), epatiche, renali, neurologiche, psichiatriche, maligne, endocrine o infettive che, secondo lo sperimentatore, potrebbero confondere i risultati dello studio o esporre il soggetto a rischi evitabili.
    9. Anamnesi di tumore maligno negli ultimi 10 anni o cancro della mammella negli ultimi 20 anni, tranne per i casi di cancro della cute, diverso dal melanoma, che siano stati rimossi o curati oppure di carcinoma in situ della cervice uterina.
    10. Malattia del rene: malattia renale attuale o precedente oppure stima della clearance della creatinina <60ml/min/1.73m2 o della creatinina sierica >1.5x limite superiore di normalità nei 28 giorni precedenti al giorno 1.
    11. Disturbo di immunodeficienza ereditario o acquisito, incluso deficit di immunoglobuline.
    12. Anamnesi di protesi articolare infetta, in qualsiasi momento, con la protesi ancora in situ. Uso precedente di cateteri o anamnesi di ulcere alle gambe, sinusite cronica o infezioni ricorrenti del torace o delle vie urinarie.
    13. Infezioni attive o anamnesi di infezioni ricorrenti (escluse infezioni micotiche ricorrenti del letto ungueale) o necessità di gestione di infezioni acute o croniche, come segue:
    a. Attualmente sottoposto a qualsiasi terapia di soppressione per un'infezione cronica (quale tubercolosi o infezione da pneumocystis, citomegalovirus, virus dell'herpes simplex, herpes zoster e micobatteri atipici).
    OPPURE
    b. Ricovero ospedaliero per il trattamento dell'infezione nelle 26 settimane precedenti al giorno 1.
    OPPURE
    c. Uso di agenti antimicrobici (antibatterici, antivirali, antimicotici o antiparassitari) parenterali (EV o IM) nelle 26 settimane precedenti al giorno 1 oppure di agenti antimicrobici orali nei 14 giorni precedenti al giorno 1.
    14. Una vaccinazione (con virus vivo o attenuato) nei 30 giorni precedenti al giorno 1 o una vaccinazione BCG nei 365 giorni precedenti al giorno 1 oppure una vaccinazione con virus vivo pianificata durante il corso dello studio.
    15. Qualsiasi procedura chirurgica, inclusi gli interventi di chirurgia ossea o articolare/sinoviectomia nelle 12 settimane precedenti al giorno 1 o qualunque intervento chirurgico pianificato entro la durata dello studio o il relativo periodo di follow-up.
    16. Per i soggetti nel sottostudio di actigrafia: sedia a rotelle, ausili alla deambulazione, arti artificiali; anamnesi di allergia cutanea grave; dispositivo impiantabile attivo; pacemaker
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve DAS28(CRP) remission (DAS28(CRP) <2.6)
    Percentuale di soggetti che ottengono un punteggio DAS28(CRP) con remissione (DAS28(CRP) <2.6)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 24
    Alla Settimana 24
    E.5.2Secondary end point(s)
    Major Secondary Efficacy Endpoints:
    - Change from baseline in DAS28(CRP) at Week 12 (to support dose response evaluation).
    - Proportion of subject achieving DAS28(CRP) remission at all assessment timepoints.
    - Change from baseline in DAS28(CRP) at all assessment timepoints.
    - Time to first DAS28(CRP) remission.
    - Proportion of subjects achieving categorical DAS28(CRP) response (moderate/good EULAR response) at all assessment timepoints.
    - ACR 20/50/70 response rates at all assessment timepoints.
    - Index- and Boolean-based ACR/EULAR remission rates, and CDAI remission rate at all assessment timepoints.
    - Change from baseline in SDAI and CDAI at all assessment timepoints.
    - Change from baseline in HAQ-DI score at all assessment timepoints.
    - Change from baseline in pain score at all assessment timepoints.
    - Change from baseline in physical and mental component scores and in domain scores of SF-36 at all assessment timepoints.
    - Change from baseline in FACIT-Fatigue at all assessment timepoints.
    - Change from baseline in BFI Question 3 at all assessment timepoints.

    Major Secondary Safety Endpoints
    - Incidence of adverse events and serious adverse events.
    - Incidence of infections.
    - Incidence of pulmonary events.
    Principali endpoint secondari di efficacia:
    - Variazione di DAS28(PCR) rispetto al basale alla settimana 12 (a supporto della valutazione della risposta alla dose).
    - Percentuale di soggetti che ottengono la remissione DAS28(PCR) in tutti i momenti della valutazione.
    - Variazione di DAS28(PCR) rispetto al basale in tutti i momenti della valutazione.
    - Tempo alla prima remissione DAS28(PCR)
    - Percentuale di soggetti che ottengono una risposta DAS28(PCR) categorica, intesa come risposta EULAR (European League Against Rheumatism) moderata/buona, in tutti i momenti della valutazione
    - Tassi di risposta 20/50/70 ACR (American College of Rheumatology) in tutti i punti temporali della valutazione
    - Tassi di remissione e indice basati su ACR/EULAR booleani e tasso di remissione CDAI (Clinical Disease Activity Index) in tutti i momenti della valutazione.
    - Variazione di SDAI (Simplified Disease Activity Index) e CDAI rispetto al basale in tutti i momenti della valutazione
    - Variazione del punteggio HAQ-DI (Health Assessment Questionnaire Disability Index) rispetto al basale in tutti i momenti della valutazione.
    - Variazione del punteggio del dolore rispetto al basale in tutti momenti della valutazione.
    - Variazione dei punteggi dei componenti fisici e mentali rispetto al basale nei punteggi di dominio di SF-36 (Short Form Health Survey) in tutti i momenti della valutazione.
    - Variazione dell'affaticamento FACIT (Functional Assessment of Chronic Illness Therapy) rispetto al basale in tutti i momenti della valutazione
    - Variazione del punteggio alla Domanda 3 BFI (Brief Fatigue Inventory) rispetto al basale in tutti i momenti della valutazione.

    Principali endopint secondari di sicurezza:
    - Incidenza di eventi avversi ed eventi avversi gravi.
    - Incidenza di infezioni.
    - Incidenza di eventi polmonari.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to section E.5.2
    Si prega di fare riferimento alla sezione E.5.2
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicit¿
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial6
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Canada
    Chile
    Mexico
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    Belgium
    Bulgaria
    Czechia
    Estonia
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Spain
    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 years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days12
    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: 179
    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 134
    F.4.2.2In the whole clinical trial 210
    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)
    The investigator is responsible for ensuring that consideration has been given to the post-study care of the subject's medical condition, whether or not GSK is providing specific post-study treatment
    Lo sperimentatore ¿ responsabile di assicurare che vengano fatte adeguate considerazioni per le cure successive allo studio in base alla condizione medica del soggetto, sia nel caso il promotore fornisca un trattamento specifico dopo lo studio, sia che non lo fornisca.
    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 Decision2015-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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