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    Summary
    EudraCT Number:2010-021283-14
    Sponsor's Protocol Code Number:NN8226-3875
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-021283-14
    A.3Full title of the trial
    A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20
    (109-0012) in subjects with rheumatoid arthritis.

    Ensayo de dosis múltiples, aleatorizado, doble ciego y controlado con placebo de anti IL 20 (109 0012) en pacientes con artritis reumatoide.
    A.4.1Sponsor's protocol code numberNN8226-3875
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAnti-IL-20 (109-0012)
    D.3.2Product code NNC 0109-0000-0012
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNNC 0109-0000-0012
    D.3.9.3Other descriptive nameAnti-IL-20
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal antibody
    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
    Artritis reumatoide
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el cambio en la actividad de la enfermedad tras 12 semanas de administración s.c. de NNC109 0012 en dosis de 3 mg/kg frente a placebo en pacientes con AR activa con tratamiento de fondo estable con MTX.
    E.2.2Secondary objectives of the trial
    ? Evaluar los signos de eficacia clínica determinados por el cambio en la actividad de la enfermedad (puntuaciones de ACR), respuestas clínicas (criterios de respuesta EULAR) y biomarcadores FD durante y después de 12 dosis repetidas de NNC109 0012
    ? Evaluar la seguridad y tolerabilidad durante y después de 12 dosis repetidas de NNC109 0012
    ? Evaluar el perfil farmacocinético (FC) de NNC109 0012 después de 12 dosis repetidas de NNC109 0012
    ? Evaluar la inmunogenicidad potencial de NNC109 0012 durante y después de 12 dosis repetidas de NNC109 0012.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Obtención del consentimiento informado antes de realizar cualquier actividad relacionada con el ensayo. (Se consideran actividades relacionadas aquellos procedimientos que no se habrían realizado durante el tratamiento normal del paciente).
    2 Diagnóstico de AR de acuerdo con el American College of Rheumatology (clasificación ACR1987) realizado al menos 3 meses antes de la selección.
    3 AR activa, caracterizada por DAS28 PCR ? 4,5 y ? 5 articulaciones inflamadas y ? 5 articulaciones dolorosas con la palpación en el recuento de 28 articulaciones
    4 Tratamiento con metotrexato (? 7,5 mg ? 25 mg/semana) durante al menos 12 semanas, con una dosis estable durante al menos las 4 semanas previas a la selección
    5 Edad entre 18 y 75 años (ambas incluidas)
    6 Todos los pacientes, independientemente del sexo, deben estar dispuestos a evitar el embarazo y la lactancia a lo largo de este ensayo y hasta 15 semanas después de la última dosis de la medicación del estudio
    a. Las mujeres deben ser posmenopáusicas o quirúrgicamente estériles (posmenopáusicas durante al menos 1 año o, de lo contrario, con folitropina [FSH] ? 26,72 U/l)
    b. Las pacientes en edad fértil deben estar dispuestas a utilizar un método anticonceptivo altamente eficaz durante el ensayo hasta la última visita o, si el paciente abandona el ensayo, durante al menos 15 semanas después de la última administración. Se definen como métodos anticonceptivos altamente eficaces aquellos que presentan un bajo índice de fracaso (es decir, menos de 1% al año) cuando se utilizan sistemáticamente y de forma correcta, como implantes, inyectables, anticonceptivos orales combinados, algunos DIU, abstinencia sexual o cónyuge con vasectomía.
    c. Las mujeres en edad fértil deben estar dispuestas a evitar la lactancia durante al menos 15 semanas después de la última administración
    d. Los varones con parejas en edad fértil deben estar dispuestos a utilizar un método anticonceptivo altamente eficaz desde la primera administración y hasta la visita final o, si el paciente se retira de forma prematura, durante las 15 semanas posteriores a la última administración
    E.4Principal exclusion criteria
    1. Índice de masa corporal (IMC) < 18,5 o > 35,0 kg/m2
    2. Los pacientes con enfermedad autoinmunitaria inflamatoria distinta de AR (excepto el síndrome de Sjögren secundario o hipotiroidismo estable)
    3. Antecedentes de enfermedad articular inflamatoria actual distinta de AR (p. ej., gota, artritis psoriásica o reactiva, enfermedad de Lyme, artritis idiopática juvenil)
    4. Enfermedad infecciosa crónica o en curso que requiera tratamiento antinfeccioso sistémico en las 2 semanas previas a la selección
    5. Antecedentes de infecciones fúngicas, víricas o bacterianas sistémicas graves en los 12 meses previos a la selección
    6. Indicios de infección por herpes zóster o citomegalovirus que se resolviera menos de 2 meses antes de la selección
    7. Neoplasia maligna pasada o actual
    8. Tratamiento con un FARME biológico con una duración adecuada y una respuesta insuficiente (fracaso del tratamiento), definida según criterio del investigador
    9. Enfermedad cardíaca o cardiovascular clínicamente significativa
    10. Resultado positivo para el virus de la inmunodeficiencia humana (VIH)
    11. Resultado positivo (serología y/o PCR) para la hepatitis B o V
    12. Prueba cutánea de la tuberculina con derivado proteico purificado (PPD) (según la normativa del país) en la selección si, de acuerdo con la normativa del país, no puede excluirse una tuberculosis latente
    13. Donación de sangre o pérdida de sangre superior a 0,45 l en los 2 meses previos a la selección, o en un período superior si así lo requiere la normativa local
    14. Falta de voluntad del paciente para seguir los procedimientos detallados en el protocolo, o incapacidad para hacerlo
    15. Cualquier otra enfermedad o alteración analítica clínicamente significativa que, según el investigador, pueda afectar a la seguridad del paciente, interferir en su participación en el ensayo o afectar al objetivo del mismo
    16. Mujeres en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Cambio en la DAS28 PCR desde el valor basal hasta la semana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Not applicable
    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 months10
    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 months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero 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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-05. Yes
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    Not applicable
    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 Decision2011-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-03
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