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    The EU Clinical Trials Register currently displays   44266   clinical trials with a EudraCT protocol, of which   7347   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-008008-42
    Sponsor's Protocol Code Number:CACZ885G2301E1
    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:2009-04-01
    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 number2008-008008-42
    A.3Full title of the trial
    Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas
    A.3.2Name or abbreviated title of the trial where available
    G2301E1
    A.4.1Sponsor's protocol code numberCACZ885G2301E1
    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 SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/527
    D.3 Description of the IMP
    D.3.1Product nameCanakinumab
    D.3.2Product code ACZ885
    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.3.8INN - Proposed INNCanakinumab
    D.3.9.2Current sponsor codeACZ885
    D.3.9.3Other descriptive nameRecombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 typeRecombinant human monoclonal antibody
    D.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/527
    D.3 Description of the IMP
    D.3.1Product nameCanakinumab
    D.3.2Product code ACZ885
    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.3.8INN - Proposed INNCanakinumab
    D.3.9.2Current sponsor codeACZ885
    D.3.9.3Other descriptive nameRecombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 typeRecombinant human monoclonal antibody
    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
    Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ? Evaluar la seguridad, tolerabilidad e inmunogenia de canakinumab a largo plazo.
    ? Evaluar la eficacia a nivel exploratorio investigando el control de la enfermedad definido por el mantenimiento de al menos un ACR 30 pediátrico adaptado durante la fase de extensión.
    E.2.2Secondary objectives of the trial
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito de los padres o del tutor legal y asentimiento del niño/a, si procede, o consentimiento informado del paciente en caso de tener ? 18 años de edad antes de que se realice cualquier actividad relacionada con el estudio.
    2. Los siguientes pacientes serán elegibles para participar en el estudio de extensión abierto (CACZ885G2301E1):
    ? Pacientes del estudio CACZ885G2305 o CACZ885G2301 que alcanzaron un ACR 30 pediátrico adaptado 15 después de tomar la dosis inicial de canakinumab, pero que experimentan un brote durante ese periodo de tiempo o después.
    ? Pacientes que en el estudio CACZ885G2301 no son elegibles para participar en la Parte II (fase de retirada) porque no pudieron cumplir los criterios de entrada de corticoides de 0,5 mg/kg de prednisona oral (o equivalente), o porque no pudieron reducir la dosis de esteroides en al menos 0,3 mg/kg (remítase al protocolo CACZ885G2301 para una descripción más detallada de las reglas).
    ? Pacientes que respondieron en la Parte I o II que no presentaron brotes cuando se interrumpió el CACZ885G2301.
    E.4Principal exclusion criteria
    1. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado por un resultado positivo de la prueba de embarazo en orina.
    2. Mujeres que hayan alcanzado la madurez sexual, es decir, fisiológicamente capaces de quedarse embarazadas, A MENOS que:
    ? su profesión, estilo de vida u orientación sexual le impidan mantener relaciones sexuales con una pareja masculina o;
    ? estén utilizando un método anticonceptivo aceptable con una tasa de fallo (Índice de Pearl (IP)) < 1. Se deberán utilizar métodos anticonceptivos fiables durante todo el estudio y durante los 2 meses posteriores a la discontinuación del fármaco del estudio.
    3. Antecedentes de hipersensibilidad al fármaco del estudio o a otros productos biológicos.
    4. Características biológicas del SAM tales como hemorragias, disfunción del sistema nervioso central, hepatomegalia, nivel de fibrinógeno en plasma < 2,5 g/L, citopenia, hipertrigliceridemia, disminución del recuento de plaquetas, aumento de la aspartato transaminasa, hiperferritemia (Ravelli, Magni-Manzoni y Pistorio 2005)) o antecedentes de pericarditis recurrente, miocarditis, serositis o características biológicas del SAM durante el CACZ885G2305 o CACZ885G2301.
    5. Infección bacteriana, fúngica o vírica activa o recurrente en el momento de la inclusión, incluyendo pacientes infectados con el virus de la inmunodeficiencia humana (VIH), la hepatitis B y la hepatitis C. Se realizará una prueba para la hepatitis y el VIH en la visita 1, como prueba de seguimiento en el caso de que no se hubiese realizado una durante el mes previo. El paciente podrá seguir recibiendo la dosis antes de conocer el resultado, ya que esto ya se había confirmado en estudios anteriores. En el apartado 7.2.1 se describen de forma más detallada los resultados positivos.
    6. Factores de riesgo para la tuberculosis (TB), como por ejemplo:
    ? Antecedentes de alguno de los siguientes: haber permanecido en un espacio cerrado en el que hubiese un gran número de personas (p. ej., la cárcel o la prisión, refugio para personas sin hogar o instalaciones para el cuidado de enfermos crónicos), toxicomanía (p. ej., sustancias inyectadas o no inyectadas), haber trabajado en asistencia sanitaria sin protección y haber estado expuesto a pacientes con un alto riesgo de TB o pacientes con enfermedad de TB antes de identificar la misma y de tomar las medidas de precaución pertinentes frente a la contaminación aérea del paciente, o
    ? Contacto frecuente (es decir, compartir el mismo espacio aéreo en una casa o en otro ambiente cerrado durante un periodo de tiempo prolongado (días o semanas, ni minutos ni horas)) con una persona con TB pulmonar activa durante el último año.
    ? Se realizará una prueba de TB de seguimiento en la visita 1,en el caso de que no se haya realizado una durante el mes previo (el investigador puede seleccionar la mejor opción para el paciente: PPD o QuantiFERON), pero no será necesario que el resultado esté disponible antes de la administración de la dosis, ya que esto se confirmó en estudios previos.
    7. Cualquier condición metabólica, renal, hepática, infecciosa o gastrointestinal subyacente que según la opinión del investigador inmunocompromete al paciente o sitúa al paciente en un riesgo inaceptable para participar en un tratamiento inmunomodulador. En particular, evidencia clínica o antecedentes de esclerosis múltiple o de otras enfermedades desmielinizantes o del Síndrome de Felty.
    8. Problemas médicos significativos, que según el criterio del investigador excluirán al paciente del estudio (se puede discutir con Novartis según cada caso).
    9. Antecedentes de cáncer de cualquier sistema orgánico (que no sea carcinoma localizado de células basales de la piel), tratado o no, durante los últimos 5 años, independientemente de si hay indicios de recurrencia local o metástasis.
    10. Antecedentes de distonía neurovegetativa (p. ej., antecedentes de desvanecimiento, hipotensión ortostática y arritmia sinusal).
    11. Hipertensión no controlada.
    12. Síndrome de QT largo o de QTc (calculado utilizando la fórmula de Bazett) > 450 mseg en hombres y > 470 mseg en mujeres en RPP del CACZ885G2305 o CACZ885G2301 o en la finalización del CACZ885G2301.
    13. Vacunas vivas durante los 3 meses previos al inicio del estudio. Puede que se permitan las vacunas muertas o inactivas, según el criterio del investigador.
    14. La donación o pérdida de sangre (la cantidad dependerá de la edad y el peso, volumen entre el 10 y el 20% o superior, véase Anexo 3) durante las 8 semanas previas a la primera administración de la dosis, o un periodo superior, si lo requiere la ley local.
    15. Condiciones familiares y sociales que hacen que la evaluación médica regular no sea posible.
    16. Antecedentes de abuso de alcohol o drogas durante los 12 meses previos a la administración de la dosis.
    E.5 End points
    E.5.1Primary end point(s)
    - seguridad, tolerabilidad e inmunogenia de canakinumab a largo plazo.
    - Evaluar la eficacia a nivel exploratorio investigando el control de la enfermedad definido por el mantenimiento de al menos un ACR 30 pediátrico adaptado durante la fase de extensión.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerabilidad e inmunogenicidad
    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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 88
    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 Decision2009-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
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