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    Summary
    EudraCT Number:2012-002324-32
    Sponsor's Protocol Code Number:I4V-MC-JADZ
    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:2013-01-11
    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 number2012-002324-32
    A.3Full title of the trial
    A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs
    Studio di fase III randomizzato, in doppio cieco con controllo attivo, per valutare l'efficacia e la sicurezza di Baricitinib (LY3009104) in pazienti con artrite reumatoide attiva da moderata a grave con previa esposizione limitata o nulla a farmaci antireumatici modificanti la malattia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 study in moderate to severe rheumatoid arthritis
    Studio di fase 3 sull'artrite reumatoide moderata e severa
    A.3.2Name or abbreviated title of the trial where available
    RA - BEGIN
    RA - BEGIN
    A.4.1Sponsor's protocol code numberI4V-MC-JADZ
    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 SponsorELI LILLY AND COMPANY
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post codeIN46285
    B.5.3.4CountryItaly
    B.5.4Telephone number0044 1276 483015
    B.5.5Fax number0044 1276 483378
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameBARICITINIB
    D.3.2Product code LY3009104
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBaricitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 Maxtrex
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Limited
    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
    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 INNMETHOTREXATE
    D.3.9.1CAS number 59-05-2
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 nameBARICITINIB
    D.3.2Product code LY3009104
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBaricitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 Maxtrex
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Limited
    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
    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 INNMETHOTREXATE
    D.3.9.1CAS number 59-05-2
    D.3.9.4EV Substance CodeSUB08856MIG
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 placeboTablet
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to severely active rheumatoid arthritis
    Artrite reumatoide attiva da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Artrite reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Determine whether baricitinib monotherapy is noninferior to MTX monotherapy in the treatment of patients with moderate to severe active RA who have had limited or no treatment with MTX and are naive to other conventional or biologic DMARDs, as assessed by the proportion of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24.
    Stabilire se la monoterapia con baricitinib sia non inferiore rispetto alla monoterapia con MTX nel trattamento di pazienti affetti da AR attiva da moderata a grave, con esposizione limitata o assente alla terapia con MTX e naïve nei riguardi di altri DMARD tradizionali o biologici, come valutato mediante la percentuale di pazienti che consegue un miglioramento del 20% nei criteri dell'American College of Rheumatology (ACR20) alla Settimana 24.
    E.2.2Secondary objectives of the trial
    • proportion of patients achieving ACR20 at Week 24 for baricitinib plus MTX versus MTX monotherapy • change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) score • change from baseline to Week 24 in DAS28–high-sensitivity C reactive protein (hsCRP) • change from baseline to Week 24 in structural joint damage as measured by modified Total Sharp Score (mTSS [van der Heijde method]) for baricitinib plus MTX versus MTX monotherapy • area under the curve (AUC) up to Week 24 in HAQ-DI score for baricitinib monotherapy versus MTX monotherapy • AUC up to Week 24 in DAS28-hsCRP score for baricitinib monotherapy versus MTX monotherapy
    •percentuale pazienti che soddisfa i criteri ACR20 alla settimana 24•cambiamento,dal basale alla settimana 24,del punteggio dell'Health Assessment Questionnaire- Disability Index (HAQ-DI)•cambiamento,dal basale alla Settimana 24,del punteggio del DAS28–highsensitivity hsCRP•cambiamento,dal basale alla settimana 24,del danno strutturale alle articolazioni, misurato con il punteggio mTSS• AUC fino alla settimana 24 nel punteggio HAQ-DI •AUC fino alla settimana 24 nel punteggio DAS28-hsCR
    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 SUBSTUDIES:
    Protocol Addendum I4V-MC-JADZ(1) Approved: 14-Aug-2012 To evaluate the efficacy of Baricitinib in patients with RA as measured by MRI of the dominant hand and wrist.

    ALTRI SOTTOSTUDI:
    Protocol Addendum I4V-MC-JADZ(1) Approvato: 14-Ago-2012 Valutazione di efficacia di Baricitinib mediante risonanza magnetica alla mano dominante e al polso.

    E.3Principal inclusion criteria
    • are at least 18 years of age • have a diagnosis of adult-onset RA as defined by ACR/EULAR 2010 Criteria for the Classification of RA • have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test • have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints • have a C-reactive protein (or hsCRP) measurement ≥1.2 times the upper limit of normal (ULN) • have had limited or no treatment with MTX
    Sono eleggibili per l'inclusione in questo studio pazienti di ambo i sessi, di età minima di 18 anni, affetti da AR con esordio in età adulta in base ai criteri ACR/EULAR 2010 per la classificazione dell'AR. I pazienti devono avere un'anamnesi documentata di positività del test per fattori reumatoidi e/o anticorpi anti-peptidi citrullinati ciclici, AR attiva definita come la presenza di almeno 6 articolazioni dolenti su 68 e di 6 articolazioni gonfie su 66, e con una misurazione hsCRP _1,2 volte il limite superiore della norma (ULN). Inoltre, i pazienti devono avere avuto un trattamento limitato o nullo con MTX ed essere naïve nei riguardi di altri DMARD tradizionali o biologici
    E.4Principal exclusion criteria
    • have received conventional DMARDs other than MTX•are currently receiving corticosteroids at doses >10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids•have started treatment with NSAIDs or have been receiving an unstable dosing regimen of NSAIDs•have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry•have ever received any biologic DMARD•have received interferon therapy within 4 weeks prior to study entry•have received any parenteral corticosteroid administered by intramuscular or intravenous inj•have had 3 or more joints injected with intraarticular corticosteroids•have active fibromyalgia that would make it difficult to appropriately assess RA activity•have a diagnosis of any systemic inflammatory condition other than RA•have a diagnosis of Felty’s syndrome•have had any major surgery within 8 weeks of study entry•have experienced any of the following within 12 weeks of study entry:myocardial infarction,unstable ischemic heart disease,stroke, or NYHA Stage IV heart failure•have a history or presence of cardiovascular,respiratory,hepatic, gastrointestinal,endocrine,hematological,neurological,or neuropsychiatric disorders or any other serious and/or unstable illness•are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair•have an eGFR based on the most recent available serum creatinine using the Modification of Diet in Renal Disease method of <40 mL/min/1.73 m2•have a history of chronic liver disease with the most recent available AST or ALT>1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN•have lymphoproliferative disease;or signs or symptoms suggestive of possible lymphoproliferative disease,including lymphadenopathy or splenomegaly;or active primary or recurrent malignant disease;or have been in remission from clinically significant malignancy for <5 years•have been exposed to a live vaccine within 12 w prior to planned randomization or are expected to need/receive a live vaccine during the course of the study•have a current or recent clinically serious viral,bacterial,fungal,or parasitic infection•have had symptomatic herpes zoster infection within 12 w prior to study entry•have a history of disseminated/complicated herpes zoster•are immunocompromised •have a history of active hepatitis B virus,hepatitis C virus,or human immunodeficiency virus•have screening laboratory test values outside the reference range for the population or investigative site•have screening ECG abnormalities that are clinically significant•have symptomatic herpes simplex at the time of study enrollment•have evidence of active or latent TB as documented by a positive purified protein
    • paz che hanno ricevuto DMARD convenzionali diversi MTX•paz in trattamento con corticosteroidi a dosi&gt; 10 mg al giorno di prednisone (o equivalente) o hanno ricevuto un dosaggio non stabile di corticosteroidi• paz che hanno iniziato il trattamento con FANS o hanno ricevuto un dosaggio instabile di FANS•paz che hanno iniziato fisioterapia come nuovo trattamento per l'artrite reumatoide nelle 2 settimane prima dell'ingresso nello studio•paz che hanno ricevuto qualunque DMARD biologico•paz che hanno ricevuto terapia con interferone entro 4 sett prima dell'ingresso nello studio•paz che hanno ricevuto qualsiasi corticosteroide parenterale somministrato per via intramuscolare o endovenosa•paz che hanno avuto 3 o più articolazioni trattate con corticosteroidi intra-articolari•paz con fibromialgia attiva che renderebbe difficile valutare adeguatamente l'attività RA•paz con diagnosi di una condizione infiammatoria sistemica diverso RA•paz con diagnosi di sindrome di Felty•paz che hanno avuto qualsiasi intervento chirurgico importante entro 8 sett dall’ingresso nello studio•paz con una delle seguenti condizioni manifestate entro 12 sett dall’ingresso nello studio:infarto del miocardio,cardiopatia ischemica instabile,ictus o insufficienza cardiaca NYHA stadio IV •paz con storia o presenza di malattie cardiovascolari,respiratorie,epatiche,gastrointestinali,endocrine,ematologiche,disturbi neurologici o neuropsichiatrici•paz sono in gran parte o totalmente inabili a prendersi poca o nessuna cura di sé, ad esempio, costretti a letto o sulla sedia a rotelle•paz con eGFR &lt;40 mL/min/1.73 m2•paz con storia di malattia epatica cronica valutata con valori recenti di AST o ALT&gt; 1,5 volte il limite superiore normale o bilirubina totale ≥ 1,5 volte il limite superiore normale•paz con malattia linfoproliferativa,o segni o sintomi indicativi di una possibile malattia linfoproliferativa,tra cui linfoadenopatia o splenomegalia,o per patologia maligna primaria o ricorrente,o sono stati in remissione da neoplasia clinicamente significativo per &lt;5 anni• paz esposti a vaccino vivo entro 12 sett precedenti la randomizzazione o che si prevede riceveranno vaccino vivo durante il corso dello studio•paz con infezione batterica, micotica o parassitaria attiva o recente•paz con infezione sintomatica da herpes zoster nelle 12 sett prima dell'ingresso nello studio•paz immunocompromessi da storia di herpes zoster diffuse / complicato•paz allo screening con virus epatite B,virus epatite C o virus immunodeficienza umana•paz con valori dei test di laboratorio fuori dal range di riferimento per la popolazione•paz che allo screening mostrano anomalie all’ECG clinicamente significative•paz con herpes simplex sintomatici al momento dell'ingresso in studio•paz con TBC attiva o latente,positivi a proteina purificata
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving ACR20 (noninferiority of baricitinib monotherapy to MTX monotherapy)
    Percentuale di pazienti che hanno raggiunto ACR20 (non inferiorità della monoterapia con baricitinib vs monoterapia con MTX)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    Endpoint 2:Proportion of patients achieving ACR20 (baricitinib plus MTX compared to MTX monotherapy).Endpoint 3:Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI).Endpoint 4:Change from baseline in DAS28-high-sensitivity C-reactive protein (hsCRP).Endpoint 5:Change from baseline in Modified Total Sharp Score (mTSS [van der Heijde method]).Endpoint 6:AUC of HAQ-DI (baricitinib monotherapy compared to MTX monotherapy).Endpoint 7:AUC of DAS28-hsCRP (baricitinib monotherapy compared to MTX monotherapy).Endpoint 8:Proportion of patients achieving ACR20.Endpoint 9:Proportion of patients achieving ACR50.Endpoint 10:Proportion of patients achieving ACR70 Endpoint 11:Proportion of patients achieving DAS28-hsCRP ≤3.2.Endpoint 12:Proportion of patients achieving DAS28- hsCRP <2.6.Endpoint 13:Proportion of patients achieving DAS28-ESR ≤3.2.Endpoint 14:Proportion of patients achieving DAS28-ESR <2.6
    Endpoint 2:Percentuale di pazienti che hanno raggiunto ACR20 (baricitinib più MTX vs monoterapia con MTX). Endpoint 3:Variazione dal basale nell 'indice del questionario HAQ-DI. Endpoint 4:Variazione dal basale del DAS28-alta sensibilità C-reattiva (hs-CRP). Endpoint 5:Variazione rispetto al basale del punteggio mTSS. Endpoint 6: AUC del questionario HAQ-DI (monoterapia baricitinib vs monoterapia con MTX). Endpoint 7: AUC della proteina DAS28 -hs-CRP (monoterapia baricitinib vs monoterapia con MTX) Endpoint 8:Percentuale di pazienti che hanno raggiunto ACR20. Endpoint 9: Percentuale di pazienti che hanno raggiunto ACR50. Endpoint 10:Percentuale di pazienti che hanno raggiunto ACR70 Endpoint 11:Percentuale di pazienti che hanno raggiunto DAS28-hsCRP ≤ 3.2. Endpoint 12:Percentuale di pazienti che hanno raggiunto DAS28-hs-CRP <2.6.Endpoint 13:Percentuale di pazienti che hanno raggiunto DAS28-VES ≤ 3.2.Endpoint 14:Percentuale di pazienti che hanno raggiunto DAS28-VES <2.6
    E.5.2.1Timepoint(s) of evaluation of this end point
    Enpoints 2 to 7: Week 24 Enpoint 8: Weeks 12 and 52 Enpoints 9 to 14: Weeks 12, 24 and 52
    Endpoint da 2 a 7: settimana 24 Endpoint 8: settimane 12 e 52 Endpoint da 9 a 14: settimane 12, 24, 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 Yes
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    India
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    South Africa
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months39
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 143
    F.4.2.2In the whole clinical trial 550
    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)
    Patients who complete this study through week 52 will be eligible to participate in a separate extension study (Study I4V-MC-JADY [JADY]) lasting for up to 2 years if enrollment criteria for Study JADY are met or to the posttreatment follow-up period of this study.
    Pazienti che hanno completato questo studio per le 52 settimane saranno elegibili per la patecipazione ad uno studio di estenzione separato (I4V-MC-JADY[JADY]) per i successivi 2 anni se i criteri di arruolamento per lo studio JADY saranno adeguati o ad un posttrattamento di follow up.
    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 Decision2013-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
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