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    The EU Clinical Trials Register currently displays   42568   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2015-000665-30
    Sponsor's Protocol Code Number:CHS-0214-05
    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:2018-02-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000665-30
    A.3Full title of the trial
    An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05)
    Studio di estensione in aperto sulla sicurezza (OLSES) per valutare la sicurezza a lungo termine e la durata della risposta di CHS-0214 (CHS-0214-05)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Coherus Open-Label Safety Extension Study
    Coherus Studio di estensione in aperto sulla sicurezza
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCHS-0214-05
    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 SponsorCOHERUS BIOSCIENCES, INC.
    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 supportCoherus Biosciences Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportDaiichi Sankyo Company Ltd.
    B.4.1Name of organisation providing supportBaxter International Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBaxter Healthcare Corporation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBaxter Healthcare SA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace UK
    B.5.2Functional name of contact pointDirector of Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, 26-28 Hammersmith Grove
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW6 7HA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044 7825 587853
    B.5.5Fax number0044 208 741 6496
    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 nameetanercept
    D.3.2Product code CHS-0214
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.2Current sponsor codeCHS-0214
    D.3.9.3Other descriptive nameETANERCEPT
    D.3.9.4EV Substance CodeSUB166284
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid arthritis
    Chronic Plaque Psoriasis
    Artrite Reumatoide
    Psoriasi Cronica a Placche
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Chronic Plaque Psoriasis
    Artrite Reumatoide
    Psoriasi Cronica a Placche
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042952
    E.1.2Term Systemic rheumatoid arthritis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS 0214-04, evaluating CHS 0214 in rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.
    Valutare la sicurezza a lungo termine e la durata della risposta nei soggetti che hanno completato 48 settimane di valutazioni nell’ambito degli studi confermativi di sicurezza ed efficacia, CHS-0214-02 o CHS-0214-04, finalizzati alla valutazione di CHS-0214 rispettivamente nell’artrite reumatoide
    (rheumatoid arthritis, RA) e nella psoriasi a placche (plaque psoriasis, PsO).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have completed 48 weeks of evaluations in CHS 0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS 0214-04 and, at Week 48, had at least a PASI-50;
    2. Women who either:
    a) Are of childbearing potential with a negative urine pregnancy test at Week 0 Day 0 (considered to correspond to the Week 48 Visit of the preceding study) who agree to use 1 or more approved methods of birth control (hormonal contraception, intrauterine device, diaphragm plus spermicide, condom plus spermicide, or abstinence from heterosexual intercourse—abstinence from heterosexual intercourse will be acceptable only if it is the preferred and usual lifestyle of the subject regardless of study participation; abstinence should be practiced for the duration of the study (study duration includes the Early Termination (ET)/ Follow-up Visit) after taking the last dose of study drug; or
    b) Have been postmenopausal for at least 2 years (with amenorrhea for at least 1 year) or have had a hysterectomy, bilateral salpingo oophorectomy, or tubal ligation prior to signing the informed consent; and
    3. Able and willing to give written informed consent prior to performance of any study related procedures.
    1. Aver completato 48 settimane di valutazioni nell’ambito dello studio CHS-0214-02, presentando almeno una risposta ACR20 alla Settimana 48, oppure aver completato 48 settimane di valutazioni nell’ambito dello studio
    CHS-0214-04, presentando almeno una risposta PASI-50 alla Settimana 48.
    2. Per le donne:
    a) se in età fertile, presentare un test di gravidanza sulle urine negativo alla Settimana 0 Giorno 0 (momento che si considera corrispondere alla visita della Settimana 48 dello studio precedente) e accettare di utilizzare 1 o più metodi contraccettivi approvati (contraccezione ormonale, dispositivo intrauterino, diaframma più spermicida, preservativo più spermicida o astinenza dai rapporti eterosessuali -l’astinenza dai rapporti eterosessuali sarà considerata accettabile solo se rientra nello stile di vita preferito e abituale del soggetto, indipendentemente dalla partecipazione allo studio; l’astinenza deve essere praticata per la durata dello studio, ove la durata dello studio include la visita di interruzione anticipata (Early Termination, ET)/di follow-up dopo l’assunzione dell’ultima dose del farmaco in studio; o
    b) essere in post-menopausa da almeno 2 anni (con amenorrea da almeno 1 anno) o essere state sottoposte a isterectomia, salpingo-ooforectomia bilaterale o legatura della tube prima della firma del consenso informato; e
    3. essere in grado e disponibili a fornire il proprio consenso informato scritto prima dell’esecuzione di qualsiasi procedura correlata allo studio.
    E.4Principal exclusion criteria
    1. Men whose partners may become pregnant (do not agree to use contraception or who are not postmenopausal) or who may breastfeed during the study (Japan only specific exclusion).
    1. Soggetti di sesso maschile le cui partner potrebbero restare incinte (non accettano di utilizzare metodi contraccettivi o non sono in post-menopausa) o allattare durante lo studio (criterio di esclusione specifico solo per il Giappone).
    E.5 End points
    E.5.1Primary end point(s)
    SAFETY: Safety will be assessed by:
    • Assessment of treatment-emergent AEs;
    • Determination of subject withdrawal information;
    • Assessment of injection site reactions;
    • Assessment of changes in safety laboratory parameters, including hematology, clinical chemistry, and pregnancy tests;
    • Assessment of changes in vital signs, physical examination, and electrocardiogram findings;
    • Monitoring for tuberculosis (TB) with regular QuantiFERON®-TB Gold test (every 12 months or more frequently for regions with high incidences of TB or to evaluate signs and symptoms that might be due to TB); and
    • Assessment of immunogenicity (anti-CHS 0214 antibodies)

    EFFICACY: Durability of response will be measured as follows:
    • For subjects with RA, maintenance of an ACR20 response or greater
    • For subjects with PsO, maintenance of PASI-50 response or greater
    SICUREZZA:La sicurezza verrà valutata mediante:
    •ď€ valutazione degli AE che emergono dal trattamento;
    •determinazione delle informazioni relative al ritiro dei soggetti;
    •ď€ valutazione delle reazioni nel sito di iniezione;
    •valutazione delle variazioni nei parametri di laboratorio di sicurezza,
    inclusi esami ematologici e di chimica clinica e test di gravidanza;
    •valutazione delle variazioni nei segni vitali, nell’esame obiettivo e nei riscontri elettrocardiografici;
    •monitoraggio per la tubercolosi (TB) con test QuantiFERON®-TB Gold
    eseguito su base regolare (ogni 12 mesi o più frequentemente per le regioni ad alta incidenza di TB o per valutare segni e sintomi che potrebbero essere causati dalla TB); e
    •valutazione dell’immunogenicità (anticorpi anti-CHS-0214)

    EFFICACIA: La durata della risposta sarà misurata come segue:
    •per i soggetti con RA, mantenimento di una risposta ACR20 o superiore
    •Per i soggetti con PsO, mantenimento di una risposta PASI-50 o superiore
    E.5.1.1Timepoint(s) of evaluation of this end point
    SAFETY: At 1 month and 3 months following enrollment and every 3 months thereafter

    EFFICACY: At each visit
    SICUREZZA: a 1 mese e 3 mesi dopo l’arruolamento e
    successivamente ogni 3 mesi

    EFFICACIA: ad ogni visita
    E.5.2Secondary end point(s)
    Retained Samples: Serum samples will be collected at each visit and retained for potential analysis of serum concentration of CHS 0214, anti-drug antibodies, or other tests as necessary to evaluate AEs, loss of response, or compliance. Serum samples will not be used to assess population pharmacokinetics (PK), biomarkers, or genetics. Samples will be stored at Medpace Reference Laboratory, LLC (MRL) and may be transferred to Charles River Laboratories or other reference laboratory for analysis at the request of the Sponsor
    Conservazione dei campioni:
    Campioni di siero verranno raccolti ad ogni visita e conservati per l’eventuale analisi della concentrazione sierica di CHS-0214, degli anticorpi anti-farmaco o per altri test, secondo quanto necessario per valutare AE, perdita della risposta o compliance. I campioni di siero non saranno utilizzati per valutare la farmacocinetica (Pharmacokinetics, PK) della popolazione, i biomarcatori o la genetica. I campioni saranno conservati presso Medpace Reference Laboratory, LLC (MRL) e potranno essere trasferiti su richiesta dello Sponsor ai laboratori Charles River Laboratories o ad altro laboratorio di riferimento per l’analisi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 2 years after completion of the study (data base lock).
    Fino a 2 anni dopo il completamento dello studio (chiusura della banca dati).
    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 No
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    South Africa
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days1
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 447
    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)
    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 Decision2015-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
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