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    Summary
    EudraCT Number:2016-002937-31
    Sponsor's Protocol Code Number:MA30143
    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:2017-05-29
    Trial 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 number2016-002937-31
    A.3Full title of the trial
    An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis
    ESTUDIO ABIERTO DE UN SOLO GRUPO PARA EVALUAR LA EFECTIVIDAD Y LA SEGURIDAD DE OCRELIZUMAB EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE EN FASE TEMPRANA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
    Estudio para Evaluar la Efectividad y Seguridad de Ocrelizumab en Pacientes con Esclerosis Múltiple Remitente en fase temprana
    A.4.1Sponsor's protocol code numberMA30143
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRoche Farma S.A. (Soc.unipersonal)que realiza el ensayo en España y que actúa como representante de F.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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number34913257300
    B.5.6E-mailspain.start_up_unit@roche.com
    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/F07-01
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 nameOCRELIZUMAB
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    Relapsing remitting multiple sclerosis (RRMS)
    Esclerosis múltiple remitente recurrente (EMRR)
    E.1.1.1Medical condition in easily understood language
    RRMS is an autoimmune disease that causes inflammation of the insulating membranes (myelin) that surround nerves within the central nervous system.
    RRMS es una enfermedad autoinmune que causa la inflamación de las membranas aislantes (mielina) que rodean los nervios dentro del sistema nervioso central
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039720
    E.1.2Term Sclerosis multiple
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of ocrelizumab in early stage of RRMS
    Evaluar la efectividad del ocrelizumab en estadios tempranos del EMRR
    E.2.2Secondary objectives of the trial
    - To overview the different effectiveness measures evaluated for ocrelizumab in early stage of RRMS
    - To evaluate the safety and tolerability of ocrelizumab in early stage of RRMS
    -• Evaluar la efectividad de ocrelizumab en la fase temprana de la EMRR
    -•Diferentes variables de efectividad de ocrelizumab evaluadas en la fase temprana de la EMRR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Able to comply with the study protocol, in the investigator’s judgment
    - Age 18 − 55 years, inclusive
    - Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
    - Have a length of disease duration, from first documented clinical attack consistent with multiple sclerosis (MS) disease of <= 3 years
    - Within the last 12 months: one or more clinically reported relapse(s) or one or more signs of MRI activity
    - Expanded Disability Status Scale (EDSS) of 0.0 to 3.5 inclusive, at screening
    - For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
    Capacidad para cumplir el protocolo del estudio, según la opinión del investigador
    • Edad comprendida entre los 18 y 55 años, ambos inclusive
    • Diagnóstico definido de EMRR, de acuerdo con los criterios de McDonald revisados de 2010
    • Duración de la enfermedad, desde el primer brote clínico documentado compatible con EM, ≤ 3 años.
    • En los últimos 12 meses: Una o más recaídas notificadas clínicamente o uno o más signos de actividad en la RM
    • Puntuación EDSS de entre 0,0 y 3,5, ambos inclusive, en la selección
    • Mujeres en edad fértil: compromiso de utilizar un método anticonceptivo aceptable durante el período de tratamiento y hasta al menos 6 meses después de la última dosis del fármaco del estudio
    E.4Principal exclusion criteria
    - Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
    - Inability to complete an Magnetic resonance imaging (MRI)
    - Known presence of other neurological disorders, including but not limited to, the following:
    • History of ischemic cerebrovascular disorders or ischemia of the spinal cord
    • History or known presence of central nervous system (CNS) or spinal cord tumor
    • History or known presence of potential metabolic causes of myelopathy
    • History or known presence of infectious causes of myelopathy
    • History of genetically inherited progressive CNS degenerative disorder
    • Neuromyelitis optica
    • History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease
    • History of severe, clinically significant brain or spinal cord trauma
    Exclusions Related to General Health
    - Pregnancy or lactation
    - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
    - History or currently active primary or secondary immunodeficiency
    - Lack of peripheral venous access
    - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
    - Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study
    - Congestive heart failure
    - Known active bacterial, viral, fungal, mycobacterial infection or other infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
    - History of major opportunistic infections
    - History or known presence of recurrent or chronic infection
    - History of malignancy, including solid tumors and hematological malignancies
    - History of alcohol or drug abuse within 24 weeks prior to baseline
    - History or laboratory evidence of coagulation disorders
    Exclusions Related to Medications
    - Received any prior approved Disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
    - Receipt of a vaccine within 6 weeks prior to the baseline visit
    - Treatment with any investigational agent within 24 weeks of screening or five half-lives of the investigational drug or treatment with any experimental procedures for MS
    - Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label, including phychosis not yet controlled by a treatment and hypersensitivity to any of the constituents
    - Previous treatment with B-cell targeted therapies
    - Systemic corticosteroid therapy within 4 weeks prior to screening.
    - Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies
    - Treatment with IV Immunoglobulin within 12 weeks prior to baseline
    - Treatment with investigational DMT
    - History of recurrent aspiration pneumonia requiring antibiotic therapy
    - Treatment with fampridine/dalfamipridine unless on stable dose for ≥ 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the 96-week treatment period
    Exclusions Related to Laboratory Findings
    - Positive serum β human chorionic gonadotropin measured at screening
    - Positive screening tests for hepatitis B
    - Lymphocyte count below lower limit of normal
    - CD4 count<250/μL
    - Aspartate aminotransferase/ serum glutamic oxaloacetic transaminase or alanine aminotransferase/serum glutamic pyruvic transaminase >= 3.0 × Upper limit of normal
    - Serum creatinine >1.4 mg/dL for women or > 1.6 mg/dL for men
    - Hemoglobin < 8.5 g/dL, Platelet count <100,000/μL, Absolute neutrophil count <1.0 × 10 3/μL
    • Esclerosis múltiple progresiva secundaria (EMPS) o antecedente de EM progresiva primaria o progresiva recurrente.
    • Incapacidad para someterse a una RM
    • Presencia conocida de otros trastornos neurológicos, entre ellos los siguientes:
     Antecedentes de trastornos cerebrovasculares isquémicos o isquemia de la médula espinal.
     Antecedentes o presencia conocida de un tumor en el SNC o la médula espinal
     Antecedentes o presencia conocida de posibles causas metabólicas de mielopatía
     Antecedentes o presencia conocida de causas infecciosas de mielopatía
     Antecedentes de trastorno degenerativo progresivo en el SNC genéticamente hereditario
     Neuromielitis óptica.
     Antecedentes o presencia conocida de trastornos autoinmunitarios sistémicos que puedan causar una enfermedad neurológica progresiva
     Antecedentes de traumatismo grave y clínicamente importante en el encéfalo o la médula espinal

    Exclusiones relacionadas con la salud general
    • Embarazo o lactancia.
    • Cualquier enfermedad concomitante que requiera tratamiento crónico con corticosteroides o inmunodepresores sistémicos durante el estudio.
    • Antecedentes o presencia activa de una inmunodeficiencia primaria o secundaria.
    • Falta de acceso venoso periférico.
    • Antecedentes de reacciones alérgicas o anafilácticas intensas a anticuerpos monoclonales humanizados o murinos.
    • Enfermedad somática significativa o no controlada o cualquier otra enfermedad importante que impida la participación del paciente en el estudio.
    Insuficiencia cardíaca
    • Infección activa conocida de origen bacteriano, vírico, fúngico, micobateriano o de otro tipo (excluida una micosis del lecho ungueal), o cualquier episodio importante de infección que exija hospitalización o tratamiento con antibióticos por vía intravenosa (IV) durante las 4 semanas previas a la selección, o antibióticos orales durante las 2 semanas previas a la selección.
    • Antecedentes de infecciones oportunistas importantes
    • Antecedentes o presencia conocida de infección recurrente
    • Antecedentes de neoplasia maligna, como tumores sólidos y neoplasias malignas.
    • Antecedentes de alcoholismo o toxicomanía en las 24 semanas previas al momento basal.
    • Antecedentes o indicios analíticos de trastornos de la coagulación.

    Exclusiones relacionadas con medicamentos
    • Recepción de cualquier TME previo aprobado en la EM, por ejemplo, interferones, acetato de glatirámero, natalizumab, alemtuzumab, daclizumab, fingolimod, teflunomida y dimetilfumarato.
    • Recepción de una vacuna viva o atenuada en las 6 semanas previas a la visita basal.

    • Tratamiento con cualquier fármaco en investigación en las 24 semanas previas a la selección (visita 1) o el equivalente a cinco semividas del medicamento en investigación (lo que sea más largo) o tratamiento con cualquier procedimiento experimental para la EM
    • Intolerancia a los corticosteroides orales o IV, incluida metilprednisolona IV, o contraindicaciones para recibirlos.
    • Administración previa de tratamientos dirigidos a los linfocitos B (es decir, rituximab, ocrelizumab, atacicept, belimumab u ofatumumab).
    • Tratamiento con corticosteroides sistémicos en las 4 semanas previas a la selección.
    • Cualquier tratamiento previo con inmunodepresores, inmunomoduladores o antineoplásicos
    • Tratamiento con inmunoglobulinas (Ig) IV en las 12 semanas previas al momento basal.
    • Tratamiento con TME en investigación.
    • Antecedentes de neumonía por aspiración recurrente con necesidad de tratamiento antibiótico.
    • Tratamiento con fampridina/dalfamipridina (Fampyra®)/Ampyra®) a menos que sea en una dosis estable durante ≥ 30 días antes de la selección. Siempre que sea posible, los pacientes deberán recibir dosis estables durante todo el período de tratamiento de 96 semanas.

    Exclusiones relacionadas con resultados analíticos*
    • Positividad para la subunidad ß de la gonadotropina coriónica humana (hCG) en suero en el período de selección.
    • Positividad en las pruebas de cribado de hepatitis B
    • Recuento de linfocitos por debajo del límite inferior de la normalidad (LIN).
    • Recuento de CD4 < 250/μl.
    • Aspartato aminotransferasa (AST)/transaminasa glutamicooxaloacética (SGOT) en suero o alanina aminotransferasa (ALT)/transaminasa glutamicopirúvica (SGPT) en suero ≥ 3,0 veces el límite superior de la normalidad (LSN).
    • Creatinina sérica > 1,4 mg/dl (> 124 μmol/l) en las mujeres o > 1,6 mg/dl (> 141 μmol/l) en los varones.
    • Hemoglobina < 8,5 g/dl (< 5,15 mmol/l).
    • Recuento de plaquetas < 100.000/μl (< 100 × 109/l).
    • Recuento absoluto de neutrófilos < 1,0 × 103/μl.
    E.5 End points
    E.5.1Primary end point(s)
    Disease progression
    Enfermedad progresiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 4 years
    Hasta los 4
    E.5.2Secondary end point(s)
    1. Time to onset of confirmed disability progression (CDP) sustained for at least 24 weeks and 48 weeks
    2. Proportion of patients who have confirmed disability improvement (CDI), CDP for at least 24 weeks and 48 weeks at Years 1, 2 and 4
    3. Proportion of patients who have improved, stable or worsened disability compared with baseline measured by EDSS annually
    4. Mean change from baseline in EDSS score over the course of the study
    5. Time to first protocol-defined event of disease activity
    6. Time to first relapse
    7. Annualized relapse rate
    8. Proportion of patient relapse free by Weeks 48, 96, 144 and 192
    9. Proportion of patients with no evidence of protocol-defined disease activity (NEDA) over Week 96, Week 144 and Week 192
    10. Proportion of patients with no evidence of progression sustained for at least 24 weeks on all the following three components (CDP; 20% increase in timed 25 Foot Walk Test [T25FWT]; 20% increase in timed 9 hole peg test [9HPT]) between baseline and Week 96/192
    11. Proportion of patients with no active disease between Baseline and Week 96/192
    12. Change from baseline of multiple sclerosis functional composite (MSFC) and its composites (T25FW, 9HP, and Paced Auditory Serial Addition Test [PASAT]) over time
    13. Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) performed annually
    14. Total number of T1 Gd-enhancing lesions; and new and/or enlarging T2 lesion as detected by brain MRI over time
    15. Change in T1 volume over time
    16. Total number of fluid-attenuated inversion-recovery (FLAIR) lesion counts as detected by brain MRI over time
    17. Change in brain volume (including white and grey matter fractions) as detected by brain MRI over time
    18. Time to treatment discontinuation/switch
    19. Employment status score (Work Productivity and Activity Impairment Questionnaire [WPAI])
    20. SymptoMScreen score
    21. Quality of life score (Multiple Sclerosis Impact Scale [MSIS]-29)
    22. Rate and nature of adverse events
    23. Changes in vital signs, physical and neurological examinations, clinical laboratory results, locally reviewed MRI for safety and concomitant medications
    1Tiempo transcurrido hasta la aparición de progresión confirmada de la discapacidad (PCD) mantenida durante un mínimo de 24 y 48 semanas.
    2.Proporción de pacientes que presenten una mejoría confirmada de la discapacidad (MCD) durante un mínimo de 24 y 48 semanas en los años 1, 2 y 4.
    3.Proporción de pacientes que presenten una mejoría, estabilización o empeoramiento de la discapacidad con respecto al momento basal determinada anualmente mediante la Escala ampliada del estado de discapacidad (EDSS).
    4.Variación media con respecto al momento basal de la puntuación EDSS durante el transcurso del estudio
    5.Tiempo transcurrido hasta el primer episodio de actividad de la enfermedad definido en el protocolo.
    6.Tiempo transcurrido hasta la primera recaída.
    7.Tasa anualizada de recaídas.
    8.Proporción de pacientes sin recaídas en las semanas 48, 96, 144 y 192.
    9.Proporción de pacientes sin signos de actividad de la enfermedad (NEDA) según la definición del protocolo durante las semanas 96, 144 y 192,
    10.Proporción de pacientes sin signos de progresión (NEP), definida como la ausencia de progresión mantenida durante un mínimo de 24 semanas en los tres componentes siguientes (PCD; aumento de un 20% en la prueba de marcha de 7,6 m o 25 pies [T25FWT] cronometrada; aumento de un 20% en la prueba del tablero de 9 orificios [9HPT] cronometrada) entre el momento basal y la semana 96/192.
    11.Proporción de pacientes sin signos de progresión mantenida entre el momento basal y la semana 96/192.
    12.Variación con respecto al momento basal de la escala MSFC (Escala funcional compuesta de la esclerosis múltiple) y sus componentes (T25FW, 9HP y prueba de suma seriada auditiva en pasos [PASAT]) a lo largo del tiempo.
    13.Variación con respecto al momento basal del rendimiento cognitivo, determinado mediante la escala BICAMS (Evaluación cognitiva internacional breve de la esclerosis múltiple) realizada de forma anual.
    14.Número total de lesiones realzadas con Gd en T1 detectadas mediante RM cerebral a lo largo del tiempo.
    15.Variación del volumen en T1 a lo largo del tiempo
    16. Número total de lesiones en secuencia FLAIR (inversión-recuperación con atenuación de líquidos) detectadas mediante RM cerebral a lo largo del tiempo.
    17. Variación del volumen encefálico (incluidas fracciones de la sustancia blanca y gris) detectada mediante RM cerebral a lo largo del tiempo
    18.Tiempo transcurrido hasta la suspensión o cambio de tratamiento.
    19.Situación laboral (cuestionario WPAI [Cuestionario de productividad laboral y deterioro de la actividad]).
    20.SymptoMScreen.
    21.Calidad de vida (escala MSIS [Escala de repercusión de la esclerosis múltiple]-29).
    22. Tasa y naturaleza de los acontecimientos adversos
    23.Variaciones de las constantes vitales, las exploraciones físicas y neurológicas, los resultados analíticos, la RM analizada localmente a efectos de seguridad y los medicamentos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 48 weeks after the last dose of ocrelizumab
    2. Up to 4 years
    3-7. Up to 48 weeks after the last dose of ocrelizumab
    8. Weeks 48, 96, 144 and 192
    9. Weeks 96, 144 and 192
    10-11. Baseline and Week 96/192
    12-23. Up to 48 weeks after the last dose of ocrelizumab
    1. Hasta 48 semanas después de la última dosis de ocrelizumab
    2. Hasta 4 años
    3-7. Hasta 48 semanas después de la última dosis de ocrelizumab
    8. Semanas 48, 96, 144 y 192
    9. Semanas 96, 144 y 192
    10-11. Basal y semana 96/192
    12-23. Hasta 48 semanas después de la última dosis de ocrelizumab
    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 No
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA161
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Brazil
    Bulgaria
    Croatia
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Mexico
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    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
    The end of the study is defined as the last patient last visit in the B-cell monitoring of the Follow-up Period.
    El final del estudio se define como la última visita del último paciente a efectos de vigilancia de los linfocitos B del período de seguimiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 600
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 416
    F.4.2.2In the whole clinical trial 600
    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)
    Patients who discontinue treatment early will be followed up for at least 48 weeks after the last infusion of study drug. Patients who complete the 192 weeks Treatment Period and, in agreement with their treating neurologist, decide not to continue in a separate LTE study, will be followed up for at least 48 weeks after the end of the Treatment Period.
    Los pacientes que interrumpen el tratamiento temprano serán seguidos durante al menos 48 semanas después de la última infusión del medicamento del estudio. Los pacientes que completen el período de tratamiento de 192 semanas y, de acuerdo con el neurólogo que los trata, deciden no continuar en un estudio separado de LTE, serán seguidos durante al menos 48 semanas después del final del período de tratamiento
    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 Decision2017-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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