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    Summary
    EudraCT Number:2008-006443-39
    Sponsor's Protocol Code Number:ML22254
    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:2008-12-09
    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 number2008-006443-39
    A.3Full title of the trial
    Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.
    A.4.1Sponsor's protocol code numberML22254
    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 SponsorRoche Farma, 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 nameTocilizumab
    D.3.2Product code RO04877533
    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.3.9.3Other descriptive nameRoActemra
    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 typeMonoclonal 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
    Pacientes adultos con artritis reumatoide (AR) activa moderada o grave que son respondedores inadecuados a los tratamientos con FAMEs no biológicos o con anti-TNFs.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level PT
    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
    Comparar la incidencia de las reacciones a la infusión de TCZ en un tiempo de infusión de 1 hora frente a 31 minutos de infusión.
    E.2.2Secondary objectives of the trial
    - Evaluar la incidencia de acontecimientos adversos en un tiempo de infusión de 1 hora y 31 minutos de tiempo de infusión.
    - Evaluar la remisión clínica (DAS28 < 2.6) tras 24 semanas en un tiempo de infusión de 1 hora y 31 minutos de tiempo de infusión.
    - Evaluar la ACR20, ACR50, ACR70 y ACR90 tras 24 semanas en un tiempo de infusión de 1 hora y 31 minutos de tiempo de infusión.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Hombres o mujeres no embarazadas y que no estén lactando.
    -Mayor o igual 18 años
    -Pacientes que reciban tratamiento ambulatorio.
    -Pacientes con artritis reumatoide de 6 meses de duración
    -AR activa de moderada a grave:DAS28Mayor o igual 3,2
    -Los pacientes han recibido mas de 1 FAME no biológico y / o un anti-TNF a una dosis estable durante un periodo Mayor o igual ; 8 semanas antes del tratamiento (día 1).
    -Pacientes con una respuesta clínica inadecuada a una dosis estable de FAME no biológico o tratamiento anti-TNF.
    -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).
    -Pacientes que firmen 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 al SC o programada para los 6 meses después de la BL
    -Enfermedad autoinmune reumática distinta de la AR, incluyendo LES, EMTC, esclerodermia, polimiositis o afectación sistémica secundaria a la AR.Se permite la entrada de pacientes con fibrosis pulmonar intersticial que toleran tto con MTX
    El síndrome de Sjögren con AR no es exclusión
    -Antecedentes o presencia actual de enfermedad articular inflamatoria distinta de AR
    -Tto con cualquier agente en investigación en las 4 semanas previas al SC o tpo equivalente a 5 semividas del fármaco en investigación, lo que sea más largo
    -Tto previo cualquier terapia de depleción celular, incluidos los agentes en investigación
    -Tto previo con abatacept
    -Tto con gamma-globulina i.v, plasmaféresis o columna de Prosorba en los 6 meses anteriores a la BL
    -Corticoides i.ar o parenterales dentro de las 6 semanas previas a la BL
    -Inmunización con una vacuna viva/atenuada en las 4 semanas previas a la BL
    -Tto previo con TCZ
    -Cualquier tto previo con agentes alquilantes
    -Creatinina sérica>142 umol/l en mujeres y >168 umol/l en hombres y ausencia de enfermedad renal activa
    -ALT o AST > 1,5 el LSN si la muestra inicial da un valor > 1,5 veces el LSN, se puede tomar 2ª muestra durante el SC
    -Recuento de plaquetas<100x109/l
    -Hb< 5g/l
    -RAN<1x109/L
    -RAL<0,5x109/l
    -Positividad para el HBsAg o Ac frente a hepatitis C
    -BT>LSN (si la muestra inicial > LSN, se puede tomar 2ª muestra durante el SC
    -TG>10mmol/l en SC sin ayunas
    -Mujeres embarazadas o lactantes
    -Mujeres en edad fértil que no empleen un medio de anticoncepción fiable
    -Antecedentes de reacciones alérgicas o anafilácticas graves a Ac monoclonales humanos, humanizados o murinos
    -RXT con anomalía clínicamente significativa
    -Enfermedad grave concomitante no controlada, cardiovascular, del SN, pulmonar, renal, hepática, endocrina o GI
    -Pacientes con una historia de diverticulitis, diverticulosis que requiera to con antibióticos el médico deberá considerar beneficios-riesgos
    -Antecedentes de enfermedad GI inferior ulcerosa como la enfermedad de Crohn, la colitis ulcerosa u otras condiciones GI inferiores sintomáticas que pudieran predisponer a las perforaciones
    -Estados de enfermedad no controlada asma, psoriasis o enfermedad inflamatoria intestinal, en las que los brotes son tratados con corticoides por v.o o parenteral
    -Enfermedad hepática en curso según determine el investigador principal, pacientes con historial de ALT elevada no excluidos
    -Infecciones conocidas activas, o historia de infecciones conocidas recurrentes de tipo micobacterianas, fúngicas, víricas o bacterianas (entre las que se incluyen, la TB, la enfermedad micobacteriana atípica, anomalías clínicas significativas en RXT determinadas por el investigador, la HB y C, el herpes zoster, pero se excluyen las infecciones fúngicas del lecho ungueal), o cualquier episodio importante de infección que haya requerido hospitalización o tto con antibióticos por vía i.v en las 4 semanas previas al SC o antibióticos por v.o en las 2 semanas previas a la SC
    -Inmunodeficiencia 1ª o 2ª
    -Neoplasia maligna activa, diagnosticada en los 5 años anteriores (incluidos los tumores sólidos y hematológicos, excepto el carcinoma cutáneo no melanocítico que haya sido extirpado y curado), o cáncer de mama diagnosticado en los 5 años previos
    -TB activa. Se realizará SC de infecciones TB latentes previamente al inicio de la terapia con TCZ conforme a la guía de práctica clínica de la SER. Pacientes con TB latente serán tratados con terapia antimicobacteriana estándar previamente al inicio del tto con TCZ también siguiendo la misma guía
    -Pacientes VIH+
    -Antecedentes de alcoholismo, drogadicción o toxicomanía en los seis meses previos al SC
    -Neuropatías u otras afecciones dolorosas
    -Pacientes con falta de acceso periférico venoso
    -Peso>150kg
    E.5 End points
    E.5.1Primary end point(s)
    Se proporcionarán estadísticas descriptivas para la incidencia de reacciones infusionales, así como estimaciones del riesgo de reacción infusional en cada grupo y de la diferencia de riesgo entre los dos grupos.
    A menos que se indique otra cosa, los intervalos de confianza para las proporciones se computarán usando el método exacto basado en la distribución Binomial.
    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 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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Infusion en 1 hora
    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 concerned27
    E.8.5The trial involves multiple Member States No
    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
    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 months6
    E.8.9.1In the Member State concerned 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 state80
    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 Decision2009-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
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