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    Summary
    EudraCT Number:2011-002067-20
    Sponsor's Protocol Code Number:RA0077
    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:2012-09-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002067-20
    A.3Full title of the trial
    A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate
    Studio comparativo multicentrico, randomizzato, in singolo cieco, a gruppi paralleli per la valutazione dell`efficacia a breve e a lungo termine di certolizumab pegol piu' metotrexato rispetto ad adalimumab piu' metotrexato in soggetti con artrite reumatoide da moderata a grave che non risponde adeguatamente a metotrexato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide
    Studio per valutare l'efficacia a breve e a lungo termine di CZP rispetto a Adalimumab, entrambi utilizzati con Metotrexato (MTX), nel trattamento di soggetti affetti da artrite reumatoide (AR) che non rispondono adeguatamente a MTX. Adalimumab e' un anticorpo monoclonale umano ricombinante specifico per la proteina TNF, approvato per il trattamento dell'AR da moderata a grave in USA, EU e diversi Paesi del mondo
    A.4.1Sponsor's protocol code numberRA0077
    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 SponsorUCB PHARMA SA/NV.
    B.1.3.4CountryBelgium
    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 supportUCB Pharma SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointCT Registries & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred Nobel Strasse 10
    B.5.3.2Town/ cityMonheim am Rhein
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 48 1515
    B.5.5Fax number+49 2173 48 1572
    B.5.6E-mailclinicaltrials@ucb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cimzia
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCERTOLIZUMAB PEGOL
    D.3.9.1CAS number 428863-50-7
    D.3.9.4EV Substance CodeSUB25423
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP 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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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
    Moderate to severe rheumatoid arthritis
    Artrite Reumatoide 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 LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    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
    The primary objectives of this study in adult subjects with moderate to severe RA responding inadequately to MTX are as follows: - To demonstrate the superiority of short term (Week 12) treatment in CZP+MTX randomized subjects as compared with ADA+MTX randomized subjects; - To demonstrate the superiority of long term (Week 104) treatment in CZP+MTX randomized subjects as compared with ADA+MTX randomized subjects, with subjects who switch treatment (Week 12 Non Responders) counted as treatment failures.
    Gli obiettivi primari di questo studio su soggetti adulti con AR da moderata a grave che non risponde adeguatamente a MTX sono i seguenti: - dimostrare la superiorità del trattamento a breve termine (Settimana 12) con CZP+MTX rispetto ad ADA+MTX; - dimostrare la superiorità del trattamento a lungo termine (Settimana 104) con CZP+MTX rispetto ad ADA+MTX, con i soggetti che passano da un trattamento all’altro (Non-responder alla Settimana 12) considerati come fallimenti terapeutici.
    E.2.2Secondary objectives of the trial
    • To investigate whether a Week 12 decision point is better at predicting the long term (Week 104) treatment success with CZP+MTX as compared with a Week 12 decision point with ADA+MTX • To compare the percentage of subjects who meet ACR20 criteria at Week 6 between the CZP+MTX- and ADA+MTX randomized arms • To compare the percentage of subjects with DAS28(ESR) LDA at Week 6 between the CZP+MTX- and ADA+MTX randomized arms • To compare the percentage of subjects with DAS28(ESR) LDA at Week 12 between the CZP+MTX- and ADA+MTX randomized arms. FOR OTHER SECONDARY OBJECTIVES PLEASE REFER TO PROTOCOL - par 3.2 (END OF ALLOWED CHARACTERS).
    - Valutare se un punto decisionale fissato alla Settimana 12 consenta di predire il successo del trattamento a lungo termine (Settimana 104) con CZP+MTX meglio di un punto decisionale fissato alla Settimana 12 per il trattamento con ADA+MTX;- confrontare la percentuale di soggetti che soddisfano i criteri ACR20 alla Settimana 6 tra il braccio randomizzato a CZP+MTX e il braccio randomizzato ad ADA+MTX;- confrontare la percentuale di soggetti che presentano DAS28(VES) LDA alla Settimana 6 tra il braccio randomizzato a CZP+MTX e il braccio randomizzato ad ADA+MTX;- confrontare la percentuale di soggetti che presentano DAS28(VES) LDA alla Settimana 12 tra il braccio randomizzato a CZP+MTX e il braccio randomizzato ad ADA+MTX; PER GLI ALTRI OBIETTIVI SECONDARI SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO – par 3.2 (FINE CARATTERI DISPONIBILI).
    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:
    Optional genetics, genomics, and proteomics sub-study. Purpose: explore gene expression, DNA, candidate blood-borne protein biomarkers relative to risk, prognosis, and response to IMP.

    ALTRI SOTTOSTUDI:
    Sottostudio opzionale di genomica,genetica e proteomica. Scopo: indagare espress. genica,DNA e biomarcatori proteici a trasm. ematica candidati relativi a rischio,prognosi e risposta al tratt.con CZP

    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject. 2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator. 3. Subject is >=18 years of age at Screening. 4. Subject must have a diagnosis of RA at Screening, as defined by the 2010 EULAR/ACR classification criteria (Aletaha D et al, 2010). 5. Subject must have a positive rheumatoid factor (RF) and/or a positive anti cyclic citrullinated peptide antibody (anti-CCP) at Screening. 6. Subject must have moderate to severe RA disease at Screening and Baseline as defined by: • >= 4 swollen joints (of 28 prespecified joints).• DAS28(ESR) >3.2. • CRP concentration >10mg/L (or 1.0mg/dL) and/or ESR (Westergren) >= 28mm/hr. 7. Subject must have inadequately responded previously to MTX. Methotrexate-inadequate response is defined as not having achieved DAS28(ESR) <= 3.2 during the 3 to 6 months prior to the Screening Visit according to the Investigator. 8. Subject is using MTX 15 to 25mg/week orally or subcutaneously at Baseline and has used the same MTX regimen (dose and route) during the 56 days prior to Baseline. A MTX dose at a minimum of 10mg/wk orally or subcutaneously is acceptable for subjects considered by the Investigator to be intolerant to a higher dose of MTX. 9. Subject, if using oral corticosteroids at Baseline, is receiving at a stable dose of <= 10mg (unchanged for at least 28 days prior to Baseline). 10. The subject, if female, must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception from Screening through at least 10 weeks (or longer if required by local regulations) after the final dose of IMP. Male subjects must agree to ensure they or their female partner(s) use adequate contraception from Screening through at least 10 weeks (or longer if required by local regulations) after the final dose of IMP.
    1. Il soggetto deve firmare e datare un Modulo di consenso informato scritto approvato da un Comitato di revisione istituzionale (IRB)/Comitato etico indipendente (IEC). 2. Secondo il giudizio dello Sperimentatore il soggetto è affidabile e in grado di attenersi ai requisiti del protocollo (p. es. è in grado di comprendere e compilare i diari), al programma delle visite e alle istruzioni circa l’assunzione dei farmaci in studio. 3. Allo Screening il soggetto è maggiorenne. 4. Allo Screening il soggetto deve presentare una diagnosi di AR come definita in base ai criteri classificativi ACR/EULAR 2010 (Aletha D. et al., 2010). 5. Allo Screening il soggetto deve presentare positività per un fattore reumatoide (FR) e/o un anticorpo anti-peptidi ciclici citrullinati.6. Allo Screening e al Basale il soggetto deve presentare AR da moderata a grave definita in base ai criteri seguenti: &gt;= 4 articolazioni gonfie (di 28 articolazioni predefinite); DAS28 (basato sulla VES) &gt;3,2; concentrazione di PCR &gt;10 mg/L (o 1,0 mg/dL) e/o VES (misurata con il metodo di Westergren) &gt;= 28 mm/h. 7. Il soggetto deve aver risposto in misura inadeguata a un precedente trattamento con MTX. La risposta inadeguata a MTX è definita come il mancato raggiungimento, secondo il giudizio dello Sperimentatore, di un punteggio DAS28 (basato sulla VES) &lt;=3,2 durante i 3-6 mesi precedenti la Visita di screening.8. Al Basale il soggetto assume MTX a una dose di 15-25 mg/settimana per via orale o sottocutanea e ha assunto lo stesso regime (dose e via di somministrazione) nei 56 giorni precedenti il Basale. Per i soggetti che lo Sperimentatore considera intolleranti a una dose maggiore è accettabile una dose di MTX di almeno 10 mg/settimana per via orale o sottocutanea. 9. Qualora al Basale il soggetto assuma corticosteroidi per via orale, la dose deve essere stabile (senza variazioni da almeno 28 giorni precedenti il Basale) e &lt;= 10 mg. 10. I soggetti di sesso femminile devono essere in post-menopausa da almeno 1 anno, chirurgicamente sterili o devono utilizzare regolarmente un metodo di contraccezione accettabile (contraccettivi ormonali orali/parenterali/impiantabili, dispositivo intrauterino o metodo di barriera più spermicida). La sola astinenza dai rapporti sessuali non è considerata un metodo accettabile. I soggetti devono accettare di utilizzare metodi contraccettivi adeguati dallo Screening fino ad almeno 10 settimane (o più a lungo se previsto dalla normativa locale) dopo l’ultima dose di IMP. I soggetti di sesso maschile devono garantire di utilizzare, e che la/le loro partner utilizzi/no, metodi contraccettivi adeguati dallo Screening fino ad almeno 10 settimane (o più a lungo se previsto dalla normativa locale) dopo l’ultima dose di IMP.
    E.4Principal exclusion criteria
    1. Subject has previously participated in this study or has previously received any bDMARD during another clinical study or independent of another clinical study. 2. Subject has participated in another study of medication or a medical device within the previous 3 months or is currently participating in another study of a medication or medical device under investigation. 3. If a female subject, is breastfeeding, pregnant, or plans to become pregnant during the study or within 10 weeks following final dose of IMP or thereafter according to local regulations. 4. Subject has a known hypersensitivity to any components of CZP or ADA, or a history of an adverse reaction to polyethylene glycol (PEG). 5. Subject has a contraindication to the use of CZP, ADA, or MTX. 6. Subject must not have a secondary, noninflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of the IMP on the subject's primary diagnosis of RA. 7. Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis) or have a Steinbrocker IV functional capacity. 8. Subject must not have previously received any experimental nonbiological therapy. 9. Subject must be free of prohibited use or a limited use of concomitant medication as detailed in Table 6:1 of the Protocol. 10. Subject with concurrent malignancy or a history of malignancy (subjects with fewer than 3 excised basal cell carcinomas or with cervical carcinoma in situ successfully surgically treated more than 5 years prior to Screening may be included). 11. Subject with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease. 12. Subjects with a history of blood dyscrasias. 13. Subject with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease or other significant immunological/inflammatory disease including systemic lupus erythematosus or irritable bowel syndrome. 14. Subject with class III or IV congestive heart failure as defined by the New York Heart Association 1964 classification criteria. 15. Subject with a history of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis). 16. Subject with any other condition (ie, clinically significant laboratory values) which, in the judgment of the Investigator, would make the subject unsuitable for inclusion in the study. 17. Subject with a value >= 1.2xULN for any of the following liver function tests (LFTs): • Aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase [GOT]). • Alanine aminotransferase (ALT) (glutamate pyruvate transaminase [GPT]). • Gamma-glutamyl transferase (GGT). 18. Subject has history of chronic alcohol or drug abuse within the previous 6 months. 19. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study. 20. Subject with history of or current clinically active infection (including chest x-ray) with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Mycobacteria (other than tuberculosis), Blastomyces, or Aspergillus. 21. Subject with a history of chronic or recurrent infections (>3 episodes requiring antibiotics or antivirals during the preceding year), recent serious or life threatening infection within the 6 months prior to the Baseline Visit (including Herpes zoster), hospitalization for any infection in the previous 6 months, or any current sign or symptom that may indicate an infection. FOR OTHER EXCL. CRIT. REFER TO PROTOCOL PAR 6.2
    1. Il soggetto ha preso parte in passato a questo studio o ha già ricevuto un DMARD biologico nell’ambito di un altro studio clinico o a prescindere da uno studio clinico. 2. Il soggetto ha partecipato a un altro studio su un farmaco o un dispositivo medico nei 3 mesi precedenti o partecipa correntemente a un altro studio su un farmaco o un dispositivo medico sperimentale. 3. Il soggetto è in stato di gravidanza o allattamento o pianifica di sviluppare una gravidanza durante lo studio o nelle 10 (o più, conformemente alla normativa locale) settimane successive all’ultima dose di IMP. 4. Il soggetto presenta ipersensibilità nota a un componente di CZP o ADA o una storia di reazione avversa a polietilenglicole (PEG). 5. L’uso di CZP, ADA o MTX è controindicato nel soggetto. 6. Il soggetto non deve presentare un disturbo muscoloscheletrico secondario di tipo non infiammatorio (p. es. osteoartrosi o fibromialgia) che, nell’opinione dello Sperimentatore, è sufficientemente sintomatico da interferire con la valutazione dell’effetto dell’IMP sulla diagnosi primaria di AR del soggetto.7. Il soggetto non deve presentare una diagnosi di altra artrite di tipo infiammatorio (p. es. artrite psoriasica o spondilite anchilosante) né un’abilità funzionale di livello IV secondo il metodo di Steinbrocker. 8. Il soggetto non deve aver ricevuto in precedenza eventuali terapie sperimentali non biologiche. 9. Il soggetto non deve assumere alcuna terapia farmacologica concomitante il cui uso sia proibito o soggetto a limitazioni come illustrato nella Tabella 6:1 del protocollo. 10. Neoplasia maligna concomitante o pregressa (possono essere inclusi soggetti con meno di 3 carcinomi basocellulari asportati o con carcinoma in situ della cervice trattato chirurgicamente con esito positivo oltre 5 anni prima dello Screening). 11. Storia di disturbo linfoproliferativo, incluso il linfoma, o segni e sintomi indicativi di malattia linfoproliferativa. 12. Storia di discrasia ematica. 13. Storia recente o corrente, come determinato dallo Sperimentatore, di malattia renale, epatica, ematologica, gastrointestinale, endocrina, polmonare, cardiaca, neurologica o cerebrale grave, progressiva e/o non controllata o di altro disturbo immunologico/infiammatorio significativo, inclusi lupus eritematoso sistemico o sindrome dell’intestino irritabile. 14. Scompenso cardiaco congestizio di classe III o IV come definito dai criteri di classificazione della New York Heart Association del 1964. 15. Precedente o sospetta malattia demielinizzante del sistema nervoso centrale (p. es. sclerosi multipla o neurite ottica). 16. Qualsiasi altro disturbo o patologia (p. es. valori degli esami di laboratorio significativi dal punto di vista clinico) che, nell’opinione dallo Sperimentatore, renderebbe il soggetto non idoneo all’inclusione nello studio. 17. Un valore &gt;= 1,2 x ULN a uno dei seguenti test di funzionalità epatica: aspartato aminotransferasi (AST) (glutammato-ossalacetato transaminasi [GOT]); alanina aminotransferasi (ALT) (glutammato-piruvato transaminasi [GPT]); gamma-glutamiltransferasi (GGT). 18. Storia di abuso cronico di alcol o sostanze negli ultimi 6 mesi. 19. Disturbo medico o psichiatrico che, nell’opinione dello Sperimentatore, può mettere a rischio la sicurezza del soggetto o impedirgli di partecipare a questo studio. 20. Infezione clinicamente attiva pregressa o corrente (incluse infezioni accertate mediante radiografia del torace) da istoplasma, coccidi, paracoccidi, pneumocisti, micobatteri (diversi dalla tubercolosi), blastomiceti o aspergilllus. PER GLI ALTRI CRITERI DI ESCLUSIONE SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO – par 6.2 (FINE CARATTERI DISPONIBILI).
    E.5 End points
    E.5.1Primary end point(s)
    1) Percentage of subjects meeting ACR20 criteria [American College of Rheumatology 20 criteria] in the CZP+MTX randomized group compared with the ADA+MTX randomized group; 2) Percentage of subjects with DAS28(ESR) LDA [Disease Activity Score- 28 joint count(erythrocyte sedimentation rate) Low disease activity] in the CZP+MTX randomized group compared with the ADA+MTX randomized group (Group A versus Group C using all randomized subjects).
    1)percentuale di soggetti che soddisfano i criteri ACR20 [American College of Rheumatology] nel braccio randomizzato a CZP+MTX vs. il braccio randomizzato ad ADA+MTX. 2) la percentuale di soggetti che presentano DAS28(VES) LDA [‘Disease Activity Score’ 28, basato sulla velocità di eritrosedimentazione VES, relativo alle articolazioni] nel braccio randomizzato a CZP+MTX vs. il braccio randomizzato ad ADA+MTX (Groppo A vs Gruppo C considerando tutti i soggetti randomizzati).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Week 12
    2) Week 104
    1) Settimana 12
    2) Settimana 104
    E.5.2Secondary end point(s)
    Among the others: 1) The percentage of subjects with DAS28(ESR) LDA at Week 104 comparing the Week 12 Responder groups (Group A versus Group C). 2) The percentage of subjects with DAS28(ESR) LDA at Week 6 using all subjects, comparing the CZP+MTX randomized arm and the ADA+MTX randomized arm. 3) The percentage of subjects with DAS28(ESR) LDA at Week 12 using all subjects, comparing randomized treatment groups CZP+MTX and ADA+MTX. 4) The percentage of subjects with DAS28(ESR) LDA at Week 104 comparing the Week 12 Responder groups (Group A versus Group C), who also responded at Week 6 (ie, DAS28(ESR) <= 3.2 or a DAS28(ESR) CFB reduction of >= 1.2).
    Tra gli altri: 1) la percentuale di soggetti che raggiungono la DAS28(VES) LDA alla Settimana 104, confrontando i gruppi di soggetti Responder della Settimana 12 (Gruppo A vs Gruppo C). 2) la percentuale di soggetti che raggiungono la DAS28(VES) LDA alla Settimana 6 considerando tutti i soggetti, confrontando il braccio randomizzato a CZP+MTX vs. il braccio randomizzato ad ADA+MTX. 3) la percentuale di soggetti che raggiungono la DAS28(VES) LDA alla Settimana 12 considerando tutti i soggetti, confrontando il braccio randomizzato a CZP+MTX vs. il braccio randomizzato ad ADA+MTX. 4) la percentuale di soggetti che raggiungono la DAS28(VES) LDA alla Settimana 104, confrontando i gruppi di soggetti Responder della Settimana 12 (Gruppo A vs Gruppo C) che hanno inoltre risposto alla Settimana 6 (es DAS28(VES) LDA <= 3,2 o DAS28(VES) riduzione rispetto al Baseline >= 1,2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 104
    2) Week 6
    3) Week 12
    4) Week 104
    1) Settimana 104
    2) Settimana 6
    3) Settimana 12
    4) Settimana 104
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Australia
    Canada
    Mexico
    Switzerland
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months54
    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 months54
    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: 446
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 446
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 448
    F.4.2.2In the whole clinical trial 892
    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)
    Standard care
    Terapia standard
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-13
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