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    Summary
    EudraCT Number:2010-020338-25
    Sponsor's Protocol Code Number:WA20546
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-09-17
    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 number2010-020338-25
    A.3Full title of the trial
    Estudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    Oratorio
    A.4.1Sponsor's protocol code numberWA20546
    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
    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 nameocrelizumab
    D.3.2Product code RO4964913
    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 INNocrelizumab
    D.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.3Other descriptive name-
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 humanizado
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Esclerosis múltiple progresiva primaria (EMPP)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigar la eficacia del ocrelizumab en comparación con un placebo en pacientes con esclerosis múltiple progresiva primaria, medida por el tiempo hasta la aparición de progresión mantenida de la discapacidad durante el período de tratamiento, definida como un aumento en la EDSS mantenido durante al menos 12 semanas, basado en visitas regularmente programadas.
    To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to sustained disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia del ocrelizumab en comparación con un placebo, en función de:
    Tiempo hasta la progresión mantenida de la discapacidad durante el período de tratamiento, definida como un aumento en la puntuación EDSS mantenido durante al menos 24 semanas.
    Variación en la prueba de ambulación cronometrada de 25 pies entre el período basal y la semana 120.
    Variación en el volumen total de lesiones en T2 en las imágenes de RM cerebrales desde el período basal hasta la semana 120.
    Evaluar la seguridad y la tolerabilidad del ocrelizumab en pacientes con esclerosis múltiple progresiva primaria en comparación con un placebo.
    To evaluate the efficacy of ocrelizumab compared with placebo:
    ? Time to sustained disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 24 weeks
    ? Change in 25-foot timed walk from baseline to Week 120
    ? Change in total volume of T2 lesion on MRI scans of the brain
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    BANCO DE MUESTRAS DE ROCHE (RCR)
    E.3Principal inclusion criteria
    -Diagnóstico de EMPP de conformidad con los criterios revisados de McDonald (2005).
    -Edad de 18-50 años, inclusive.
    -Puntuación EDSS en el período de selección de 3,0 a 6,5 puntos
    -Duración de la enfermedad desde la aparición de los síntomas de EM:
    a.Menos de 15 años en pacientes con una puntuación EDSS en el período de selección > 5,0.
    b.Menos de 10 años en pacientes con una puntuación EDSS en el período de selección &#8804; 5,0.
    Para los pacientes de ambos sexos sexualmente activos con capacidad reproductiva, el uso de medios anticonceptivos fiables Dos métodos anticonceptivos durante todo el estudio, incluida la fase de tratamiento activo Y durante 48 semanas después de la última dosis

    -Adult patients, 18-50 years of age
    - Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
    - Expanded Disability Status Scale (EDSS) 3.0 to 6.5 points
    - Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS ? 5.0
    - Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
    E.4Principal exclusion criteria
    - Antecedentes de esclerosis múltiple remitente recidivante, esclerosis múltiple progresiva secundaria o esclerosis múltiple progresiva recidivante en el período de selección
    -Incapacidad para someterse a una exploración por RM
    -Presencia conocida de otros trastornos neurológicos
    -Infecciones activas o recurrentes o crónicas
    -Antecedentes de cáncer, incluidos tumores sólidos y neoplasias malignas hematológicas (excepto carcinomas basocelulares y carcinomas espinocelulares in situ de la piel y carcinomas in situ del cuello uterino extirpados y resueltos, con bordes limpios documentados en la anatomía patológica).
    Tratamiento previo con fármacos que actúan sobre los linfocitos B (por ejemplo, rituximab, ocrelizumab, atacicept, belimumab u ofatumumab).
    -Cualquier tratamiento previo con alemtuzumab (Campath), anticuerpos anti-CD4, cladribina, ciclofosfamida, mitoxantrona, azatioprina, micofenolato mofetilo [MMF], ciclosporina, metotrexato, radiación corporal total o trasplante de médula ósea.
    History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
    - Contraindications for Magnetic Resonance Imaging (MRI)
    - Known presence of other neurologic disorders
    - Known active infection or history of or presence of recurrent or chronic infection
    - History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
    - Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
    - Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
    E.5 End points
    E.5.1Primary end point(s)
    Aumento en la EDSS mantenido durante al menos 12 semanas, basado en visitas regularmente programadas.
    Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks from baseline to sustained disability progression
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Calidad de vida
    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 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) No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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 Yes
    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
    Fecha en que se reciba el último dato del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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) No
    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 state99
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 630
    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)
    Tras el desenmascaramiento primario, los pacientes podrían beneficiarse de continuar el trat y recibir ocrelizumab de forma no enmascarada hasta que se obtenga la autorización de comercialización. Upon completion of the Blinded Treatment, pts who could benefit from further treatment may receive open label ocrelizumab until either MA of the product or discontinuation of the program. For pts in the placebo arm, the inv may elect to commence treatment with ocrelizumab.
    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 Decision2010-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-09
    P. End of Trial
    P.End of Trial StatusOngoing
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