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    Summary
    EudraCT Number:2008-006924-68
    Sponsor's Protocol Code Number:MA22460
    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:2009-01-19
    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 number2008-006924-68
    A.3Full title of the trial
    Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.

    Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.
    A.3.2Name or abbreviated title of the trial where available
    extension MA21573
    A.4.1Sponsor's protocol code numberMA22460
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 nameTocilizumab
    D.3.2Product code RO4877533
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeRO4877533
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 typeIL6 receptor inhibitor, humanised 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 reumatoide/Rheumatoid arthritis
    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 la tolerabilidad a largo plazo de la monoterapia con TCZ o en combinación con FAMEs no biológicos en pacientes con AR y una respuesta al menos moderada al TCZ tras 24 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia a largo plazo de la monoterapia con TCZ o su combinación con FAMEs no biológicos en pacientes con AR y una respuesta al menos moderada al TCZ tras 24 semanas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para ser elegible en este ensayo los pacientes deben cumplir todos los criterios siguientes:
    -Haber completado el estudio troncal MA21573 de 24 semanas, con al menos una respuesta moderada (criterios de definición EULAR) y no haber sufrido AA, AAG o alguna enfermedad que haya supuesto un riesgo inaceptable del tratamiento continuado. Se programará las visitas para que los pacientes reciban la primera infusión de tocilizumab en el estudio MA22460 entre 4 y 16 semanas después de la última infusión i.v. en el estudio troncal
    -Estar dispuesto a dar su consentimiento informado escrito para participar en el estudio de extensión
    -Ser capaz y estar dispuesto a cumplir los requisitos del protocolo del estudio de extensión
    E.4Principal exclusion criteria
    Los pacientes con cualquiera de los criterios siguientes no serán elegibles para participar en el estudio:
    -AR de Clase funcional IV tal como queda definida en la Clasificación sobre el Estado funcional de la AR de la ACR
    Todas las mujeres en edad fértil deben tener un resultado negativo en una prueba de embarazo en orina realizada el día 1
    -Creatinina sérica > 1,6 mg/dl en mujeres y > 1,9 mg/dl en hombres y ausencia de enfermedad renal activa
    -ALT o AST &#8805; 3LSN (si la muestra inicial de ALT o AST es &#8805; 3 veces el LSN, se puede tomar y analizar una segunda muestra)
    -Recuento de plaquetas < 100 x 109 /l
    -Hemoglobina < 85 g/l
    -Leucocitos < 1,0 x 109/l, RAN < 1 x 109/l
    -Recuento absoluto de linfocitos < 0,5 x 109 /l
    -Positividad conocida para el antígeno de superficie de la hepatitis B o anticuerpos frente a hepatitis C
    -Bilirrubina total > LSN (si la muestra inicial da bilirrubina > LSN, se puede tomar y analizar una segunda muestra)
    -Triglicéridos>10 mmol/l en la inclusión en el estudio de extensión
    -Tratamiento con cualquier agente en investigación desde la última administración de la medicación en estudio del protocolo MA21573
    -Tratamiento previo con cualquier terapia de depleción celular, incluidos los agentes en fase de investigación desde la última administración de la medicación en estudio del protocolo MA21573
    -Tratamiento con gamma-globulina intravenosa, plasmaféresis o columna de Prosorba desde la última administración de la medicación en estudio del protocolo MA21573
    -Tratamiento con un anti-TNF, o anti-IL1, o moduladores de la coestimulación de las células T, o cualquier agente biológico, o haber participado en algún estudio de investigación desde la última administración de la medicación en estudio del protocolo MA21573
    -Corticoesteroides parenterales, intramusculares o intraarticulares dentro de las 6 semanas desde la última administración de la medicación en estudio del protocolo MA21573
    -Inmunización con una vacuna viva/atenuada desde la última administración de la medicación en estudio del protocolo MA21573
    -Cualquier tratamiento previo con agentes alquilantes como la ciclofosfamida o clorambucilo, o con una irradiación linfoide total desde la última administración de la medicación en estudio del protocolo MA21573
    -Mujeres en edad fértil que no empleen un medio de anticoncepción fiable, por ejemplo una barrera física (paciente y pareja), píldora o parche anticonceptivo, espermicida y barrera o un dispositivo intrauterino
    -Evidencia de enfermedad grave concomitante no controlada, cardiovascular, del sistema nervioso, pulmonar (incluida la enfermedad pulmonar obstructiva), renal, hepática, endocrina (incluida la diabetes mellitus no controlada) o gastrointestinal
    -Estados de enfermedad no controlada, tales como asma, soriasis o enfermedad inflamatoria intestinal, en las que los brotes son normalmente tratados con corticosteroides por vía oral o parenteral
    -Enfermedad hepática en curso según determine el investigador. Los pacientes con historial de ALT elevada no serán excluidos.
    -Infecciones conocidas activas o antecedentes de infecciones conocidas recurrentes de tipo micobacterianas, fúngicas, víricas o bacterianas (entre las que se incluyen, pero no exclusivamente, la tuberculosis, la enfermedad micobacteriana atípica, hepatitis B y C, herpes zoster, pero se excluyen las infecciones fúngicas del lecho ungueal), o cualquier episodio importante de infección que haya requerido hospitalización o tratamiento con antibióticos por vía i.v. o antibióticos por vía oral
    -Inmunodeficiencia primaria o secundaria (antecedentes o activa)
    -Evidencia de enfermedad tumoral activa, tumores diagnosticados en los 5 años anteriores (incluidos los tumores sólidos y tumores hematológicos, excepto el carcinoma cutáneo no melanocítico que haya sido extirpado y curado), o cáncer de mama diagnosticado en los 5 años anteriores
    -Pacientes positivos para el virus de la inmunodeficiencia humana
    -Antecedentes de alcoholismo, toxicomanía o abuso de sustancias químicas en el estudio troncal MA21573 de 24 semanas
    -Neuropatías u otras afecciones dolorosas que puedan interferir en la evaluación del dolor
    -Pacientes con falta de acceso periférico venoso
    E.5 End points
    E.5.1Primary end point(s)
    Incidencia de AA y AAG del tratamiento con TCZ en monoterapia o combinado con uno o más de los FAMEs no biológicos aprobados para la AR en pacientes con AR activa de moderada a grave
    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 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 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) 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 concerned38
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA175
    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
    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 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 months1
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 850
    F.4.2.2In the whole clinical trial 1200
    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)
    Esta informacion esta en el protocolo del estudio, seccion 6.1 "Dosificacion y calendario del medicamento en fase de investigacion"
    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 Decision2009-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-18
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    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.

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