Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44258   clinical trials with a EudraCT protocol, of which   7344   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-005320-81
    Sponsor's Protocol Code Number:CACZ885A2201E2
    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:2009-01-20
    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 number2008-005320-81
    A.3Full title of the trial
    Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa
    A.3.2Name or abbreviated title of the trial where available
    A2201E2
    A.4.1Sponsor's protocol code numberCACZ885A2201E2
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameACZ885
    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 inerleukin-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 mAb to IL-1 beta of the IgG1/Kappa-class
    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 Reumatoide
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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 la seguridad y tolerabilidad de canakinumab (ACZ885) a largo plazo en pacientes con AR activa que hayan completado el primer estudio de extensión.
    E.2.2Secondary objectives of the trial
    • Evaluar la eficacia de cankinumab (ACZ885) valorando la respuesta al tratamiento según los criterios ACR20, ACR50 y ACR70, DAS28 (véanse las definiciones en los anexos 1 y 2).
    • Evaluar el efecto de canakinumab en los componentes ACR, incluyendo un marcador de inflamación (PCRas).
    • Evaluar el perfil farmacocinético de canakinumab.
    • Evaluar la inmunogenicidad de canakinumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Los pacientes que finalizaron el estudio de extensión 1 podrán participar en el estudio de extensión 2 después de firmar el consentimiento informado.
    Si un paciente ha finalizado el estudio hasta e incluyendo la visita 31, se definirá como paciente que ha finalizado el estudio de extensión 1.
    E.4Principal exclusion criteria
    1. Los pacientes cuyo tratamiento continuado en la extensión 2 no es considerado apropiado por el médico.
    2. 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 del análisis de hCG (> 5 mUI/mL).
    3. Mujeres potencialmente fértiles (WOCBP), definidas como todas las mujeres que sean fisiológicamente capaces de quedarse embarazadas, A MENOS que:
    • Utilicen un método anticonceptivo de doble barrera como dispositivos intrauterinos (DIU), anticonceptivos orales, implantes subdérmicos y un método de barrera con espermicida, preservativos.
    • Sean mujeres cuyas parejas hayan sido esterilizadas mediante vasectomía u otros medios.
    • Se consideren postmenopáusicas y no sean potencialmente fértiles si han tenido 24 meses de amenorrea natural (espontánea) o seis meses de amenorrea espontánea con concentraciones de la FSH en suero > 40 mUI/mL (en EE.UU. únicamente estradiol < 20 pg/mL) o han tenido ooforectomía bilateral quirúrgica (con o sin histerectomía) desde al menos hace seis semanas. En el caso de ooforectomía sola, únicamente cuando el estado reproductivo de la mujer haya sido confirmado por una evaluación de seguimiento del nivel hormonal.
    Nota: Las pruebas de FSH y estradiol no es necesario que se realicen en mujeres estériles quirúrgicamente o mujeres en terapia estrogénica sustitutiva.
    Las mujeres potencialmente fértiles deberán acceder a continuar utilizando un método anticonceptivo aceptable durante el ensayo y durante al menos 2 meses después de finalizar el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo de eficacia principal de canakinumab (ACZ885) es evaluar la respuesta al tratamiento (criterios ACR20, ACR50 y ACR70, DAS28).

    Respuestas ACR20, ACR50, ACR70:
    Se considerara que un paciente mejora según los criterios ACR50 (ACR20, ACR70 respectivamente) si tiene al menos una mejoría del 50% (el 20, 70% respectivamente) en el recuento de las 28 articulaciones dolorosas e inflamadas, y en al menos 3 de las 5 medidas siguientes:
    • Evaluación del dolor del paciente (EVA 100 mm)
    • Evaluación global de la actividad de la enfermedad por el paciente (EVA 100 mm)
    • Evaluación global de la actividad de la enfermedad por el médico (EVA 100 mm)
    • Evaluación de la capacidad funcional del paciente por el paciente (Puntuación del cuestionario de evaluación de la salud [HAQ©])
    • Reactante de fase aguda (proteína C reactiva de alta sensibilidad [PCRas])
    Los pacientes se definirán como respondedores ACR50 al tratamiento en una visita postaleatorización dada si cumplen los criterios ACR50 (ACR20, ACR70 respectivamente). Los pacientes se considerarán no respondedores ACR50 si no cumplen los criterios ACR50 (ACR20, ACR70 respectivamente). Los pacientes que se retiren prematuramente del estudio debido a un efecto terapéutico insuficiente también se considerarán no respondedores.
    La mejoría se evaluará según el valor basal del estudio principal.
    ACR20, ACR50 y ACR70 se evaluarán en las semanas 88, 100, 112, 124, 136, 148, 160, 172 y 184 (FdE).
    La frecuencia y porcentaje de respondedores, no respondedores se mostrará en cada periodo de tiempo.

    DAS28:
    DAS28 (Prevoo MLL et al., 1995; Fransen J et al., 2003) se derivará (Anexo 2) del recuento de articulaciones inflamadas, recuento de articulaciones dolorosas, PCRas y evaluación global de la actividad de la enfermedad por el paciente para la basal (en el estudio principal), en las semanas 88, 100, 112, 124, 136, 148, 160, 172 y 184 (FdE).
    Se mostrarán resúmenes estadísticos DAS28 con el cambio respecto al valor basal en cada periodo de tiempo.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 160
    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)
    Expect marketing authorisation
    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 Decision2009-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-15
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA