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    Summary
    EudraCT Number:2008-000587-17
    Sponsor's Protocol Code Number:MA21573
    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:2008-05-26
    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 number2008-000587-17
    A.3Full title of the trial
    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.

    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.4.1Sponsor's protocol code numberMA21573
    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 Roche
    D.3.2Product code RO4877533 (TCZ)
    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.3.9.2Current 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 tolerabilidad de TCZ en monoterapia o en combinación con FAMEs no biológicos en pacientes con AR activa de moderada a grave.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia de TCZ en monoterapia o en combinación con FAMEs no biológicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Hombres o mujeres no embarazadas y que no estén lactando.
    2.≥ 18 años de edad.
    3.Diagnóstico de AR activa de moderada a grave (DAS28 ≥ 3,2) de ≥ 6 meses de duración.
    4.Pacientes que reciban tratamiento ambulatorio.
    5.Los pacientes han recibido ≥ 1 FAME no biológico a una dosis estable durante un periodo ≥ 8 semanas antes del tratamiento (día 1).
    6.Pacientes con una respuesta clínica inadecuada a una dosis estable de FAME no biológico o tratamiento anti-TNF.
    7.Si los pacientes están recibiendo un corticosteroide oral, la dosis debe haber sido estable durante al menos 25 de 28 días antes del tratamiento (día 1).
    8.Pacientes que sean capaces y deseen firmar el consentimiento informado y que cumplan con los requisitos del protocolo del estudio.
    E.4Principal exclusion criteria
    -Intervenciones quirúrgicas importantes dentro de las 8 semanas previas a selección o programadas 6 meses después de la aleatorización
    -Enfermedad autoinmune reumática distinta de AR incluyendo lupus eritematoso sistémico, enfermedad mixta del tej. conjuntivo, esclerodermia, polimiositis o afectación sistémica 2aria a la AR
    Se permite entrada de pacientes con fibrosis pulmonar intersticial capaces de tolerar el tratamiento con MTX
    Síndrome de Sjögren con AR no es criterio de exclusión
    -AR de Clase funcional IV definida en la ACR,incapacidad completa o considerable con el paciente confinado a la cama o silla de ruedas que no puede realizar su atención personal
    -Antecedentes o presencia de enfermedad articular inflamatoria distinta de AR
    -Tratamiento con cualquier agente en investigación en las 4 semanas previas a la selección o tiempo equivalente a 5 semividas del fármaco en investigación, lo más largo
    -Tratamiento previo cualquier terapia de depleción celular, incluidos agentes en investigación
    -Tratamiento previo con abatacept
    -Tratamiento con gamma-globulina i.v., plasmaféresis o columna de Prosorba en los 6 meses previos a la basal
    -Corticoesteroides intraarticulares o parenterales dentro de las 6 semanas previas a la basal
    -Inmunización con una vacuna viva/atenuada en las 4 semanas previas a la basal
    -Tratamiento previo con TCZ,una exención a este criterio de exclusión puede concederse para una exposición de dosis única después de solicitarlo al promotor caso por caso
    -Tratamiento previo con agentes alquilantes como ciclofosfamida, clorambucilo, o irradiación linfoide total
    -Creatinina sérica>142 umol/l (1,6mg/dl) en mujeres y>168 umol/l (1,9mg/dl) en hombres y ausencia de enfermedad renal activa
    -ALT o AST>1,5 el LSN (si la muestra inicial de ALT o AST da un valor>1,5 veces el LSN, se puede tomar y analizar una 2ª muestra durante el periodo de selección)
    -Plaquetas< 100x109/l (100.000/mm3)
    -Hemoglobina< 85 g/dl (< 8,5g/l, 5,3mmol/l)
    -Leucocitos<1,0x109/l (1000/mm3), RAN< 0,5x109/L (500/mm3)
    -RAL<0,5x109/l (500/mm3)
    -Positividad para el Ag de superficie de la hepatitis B o Ac frente a hepatitis C
    -Bilirrubina total>LSN (si la muestra inicial de bilirrubina>LSN, se puede tomar y analizar una 2ª muestra durante el periodo de selección)
    -TG>10 mmol/l(>900 mg/dl) en la visita de selección (sin estar en ayunas)
    -Mujeres embarazadas o lactantes
    -Mujeres en edad fértil que no empleen un medio de anticoncepción fiable,barrera física (paciente y pareja), píldora o parche anticonceptivo, espermicida y barrera o DIU
    -Antecedentes de reacciones alérgicas o anafilácticas graves a los Ac monoclonales humanos, humanizados o murinos
    -Evidencia en RXT de una anomalía clínicamente significativa
    -Evidencia de enfermedad grave concomitante no controlada, cardiovascular, del S.N., pulmonar (incluida enfermedad pulmonar obstructiva), renal, hepática, endocrina (incluida diabetes mellitus no controlada) o G.I.
    -Pacientes con historia de diverticulitis, que requiera tratamiento con antibióticos, el médico deberá considerar beneficios-riesgos
    -Antecedentes de enfermedad GI inferior ulcerosa como enfermedad de Crohn, colitis ulcerosa u otras condiciones GI inferiores sintomáticas que pudieran predisponer a perforaciones
    -Estados de enfermedad no controlada, como asma, psoriasis o enfermedad inflamatoria intestinal, en las que los brotes son tratados con corticoesteroides por v.o./ parenteral
    -Enfermedad hepática en curso según determine el medico. Pacientes con historial de ALT alta no serán excluidos
    -Infecciones conocidas activas, o historia de infecciones conocidas recurrentes de tipo micobacterianas, fúngicas, víricas o bacterianas (se excluyen infecciones fúngicas del lecho ungueal), o cualquier episodio importante de infección que haya requerido hospitalización o tratamiento con antibióticos por vía i.v en las 4 semanas previas a la selección o antibióticos por vía v.o. en las 2 semanas previas a la selección
    -Inmunodeficiencia 1aria o 2aria
    -Evidencia de neoplasia maligna activa, diagnosticada en los 5 años anteriores (incluidos tumores sólidos y hematológicos, excepto carcinoma cutáneo no melanocítico extirpado y curado), o cáncer de mama diagnosticado en los 5 años previos
    -Tuberculosis activa que requiera tratamiento en los 3 años previos. Pacientes con resultado + en la prueba cutánea de tuberculina con derivado proteico purificado en la visita de selección, según las directrices locales no son elegibles a menos que completen un tratamiento para la TB latente o que presenten una RXT negativa en el momento del reclutamiento
    Pacientes tratados para la TB sin recurrencias en los últimos 3 años no serán excluidos
    -Pacientes VIH+
    -Antecedentes de alcoholismo, drogas o toxicomanía en los 6 meses previos a la selección
    -Neuropatías o afecciones dolorosas que puedan interferir en la evaluación del dolor
    -Pacientes con falta de acceso periférico venoso
    -Peso>150kg
    E.5 End points
    E.5.1Primary end point(s)
    Incidencia de AA y AAG durante las 24 semanas 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) 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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA240
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1400
    F.4.2.2In the whole clinical trial 1500
    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 Decision2008-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-30
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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
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