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    Summary
    EudraCT Number:2010-021577-37
    Sponsor's Protocol Code Number:ALT4864g
    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:2010-11-23
    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 number2010-021577-37
    A.3Full title of the trial
    ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVA
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE
    EFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYING
    ANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS
    A.4.1Sponsor's protocol code numberALT4864g
    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 SponsorGENENTECH, Inc
    B.1.3.4CountryUnited States
    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 nameN/A
    D.3.2Product code MLTA3698A
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMLTA3698A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 typehumanized monoclonal antibody produced in Chinese hamster ovary cells
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name HUMIRA 40 mg solución inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form 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 INNADALIMUMAB
    D.3.9.3Other descriptive nameADALIMUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 typeanticuerpo monoclonal humano recombinante expresado en células de Ovario de Hámster Chino.recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    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 12.1
    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 eficacia de MLTA3698A en comparación con adalimumab (ADA), utilizado en combinación con dosis estables de metotrexato (MTX) o leflunomida (LFU), en pacientes con artritis reumatoide (AR) activa con respuesta insuficiente a cualquiera de estos fármacos antirreumáticos modificadores de la enfermedad (FARME).
    Evaluar la seguridad y tolerabilidad de MLTA3698A.
    - To evaluate the efficacy of MLTA3698A compared with adalimumab (ADA), used in combination with stable doses of methotrexate (MTX) or leflunomide (LFU), in patients with active rheumatoid arthritis (RA) who have had an inadequate response to either of these disease-modifying anti-rheumatic drugs (DMARDs)
    - To evaluate the safety and tolerability of MLTA3698A
    E.2.2Secondary objectives of the trial
    Caracterizar el perfil farmacocinético de MLTA3698A utilizado en combinación con dosis estables de MTX o LFU en pacientes con AR activa.
    Caracterizar la inmunogenicidad de MLTA3698A mediante la medición de anticuerpos contra este medicamento.
    Evaluar los efectos de MLTA3698A en comparación con ADA, utilizado en combinación con dosis estables de MTX o LFU, sobre las mediciones de los resultados comunicados por los pacientes

    To characterize the pharmacokinetic profile of MLTA3698A used in combination with stable doses of MTX or LFU in patients with active RA
    To characterize the immunogenicity of MLTA3698A by measurement of anti-therapeutic antibodies
    To evaluate the effects of MLTA3698A compared with ADA, used in combination with stable doses of MTX or LFU, upon patient-reported outcome measures
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUBESTUDIO DE DEPÓSITO DE ADN ASOCIADO AL ESTUDIO ALT4864g DE MLTA3698A
    E.3Principal inclusion criteria
    Diagnóstico de AR según la revisión de 1987 de los criterios ACR para la clasificación de la AR (véase el apéndice C) durante al menos 6 meses antes de la selección.
    Edad de 18 a 75 años en la selección.
    Peso corporal de 50 a 120 kg e índice de masa corporal de 19 a 35 kg/m2.
    Positividad del factor reumatoide o de los anticuerpos anti-PCC, o de ambos.
    Enfermedad activa, definida por la presencia de todo lo siguiente:
    PCR 1,0 mg/dl en el momento de la selección.
    Recuento de articulaciones inflamadas 6 (de un total de 66 articulaciones) en la selección y en el momento basal (día 1).
    Recuento de articulaciones dolorosas 6 (de un total de 68 articulaciones) en la selección y en el momento basal (día 1).
    Respuesta clínica insuficiente previa a al menos un FARME,
    Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA (see Appendix C) for at least 6 months prior to screening
    Age 18-75 years at screening
    Body weight of 50?120 kg and body mass index of 19?35 kg/m2
    Positive for rheumatoid factor or anti-CCP antibody, or both
    Active disease, defined as presence of all of the following:
    CRP ? 1.0 mg/dL at screening
    Swollen joint count ? 6 (66 joint count) at screening and baseline (Day 1)
    Tender joint count ? 6 (68 joint count) at screening and baseline (Day 1)
    Previous inadequate clinical response to at least one DMARD
    E.4Principal exclusion criteria
    Embarazo, previsión de embarazo durante el estudio o lactancia materna.
    Antecedentes de reacciones anafilácticas
    Antecedentes de inmunodeficiencia primaria o secundaria activa en la actualidad, incluidos antecedentes de infección por el VIH.
    Resultado positivo en la prueba QuantiFERON TB Gold (véase el apéndice L).
    Enfermedad autoinmunitaria reumática distinta de la AR, o afectación sistémica importante secundaria a AR
    Clase funcional IV, según criterios ACR
    Antecedentes o presencia de enfermedad inflamatoria articular distinta de la AR
    Neoplasia maligna o tumor maligno previo
    Tratamiento previo con ADA u otro anti-TNF o fármaco biológico
    Infección actual o reciente
    Antecedentes de infecciones importantes recurrentes
    Hospitalización por un episodio de importancia clínica en las 4 semanas previas a la selección
    Pregnant, planning to become pregnant during the study, or breastfeeding
    History of anaphylactic reactions
    History of or currently active primary or secondary immunodeficiency, including known history of HIV infection
    Positive QuantiFERON-TB Gold test (see Appendix L)
    Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
    Functional Class IV (ACR classification)
    History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
    Malignancy, or prior malignancy
    Previous treatment with MLTA3698A, ADA or other anti-TNF or biologic agents,
    Current or recent infection,
    History of recurrent significant infections
    Hospitalization for a clinically relevant event within 4 weeks prior to screening
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de la eficacia es la variación de la puntuación DAS28(4)-VSG desde el momento basal (día 1) hasta el día 85. La puntuación DAS28(4)-VSG es una puntuación de la actividad de la artritis reumatoide con cuatro componentes, velocidad de sedimentación globular (VSG), recuento de articulaciones inflamadas y dolorosas de un total de 28 articulaciones, y valoración global por el paciente de la actividad de la enfermedad (véase el apéndice F).
    The primary efficacy outcome measure is the change from baseline (Day 1) in
    DAS28(4)-ESR score at Day 85. The DAS28(4)-ESR is a Disease Activity Score in
    Rheumatoid Arthritis that takes into account four components, including erythrocyte
    sedimentation rate (ESR), tender joint count and swollen joint count from 28 joints,
    and patient?s global assessment of disease activity (see Appendix F).
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 EEA28
    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
    Último paciente última visita Last Patient Last Visit
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 200
    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 Decision2011-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
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