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    Summary
    EudraCT Number:2015-005597-38
    Sponsor's Protocol Code Number:MA30005
    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:2016-03-18
    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 number2015-005597-38
    A.3Full title of the trial
    An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment
    Estudio abierto para evaluar la eficacia y la seguridad de ocrelizumab en pacientes con esclerosis múltiple remitente-recidivante que tienen una respuesta subóptima a un ciclo adecuado de tratamiento modificador de la enfermedad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis
    Estudio para evaluar la eficacia y la seguridad de ocrelizumab en pacientes con esclerosis múltiple remitente-recidivante.
    A.3.2Name or abbreviated title of the trial where available
    CASTING
    A.4.1Sponsor's protocol code numberMA30005
    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. que representa en España a F. 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 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-mailglobal.rochegenentechtrials@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
    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-recidivante (EMRR)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis is a disabling disease of brain and spinal cord that disrupts flow of information within brain, characterized by flare-ups with periods of remission in between (relapsing remitting)
    Esclerosis múltiple es una enfermedad incapacitante en cerebro y médula espinal que interrumpe el flujo de info en cerebro, con ataques de asma con períodos de remisión en medio(recaídas y remisiones)
    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 18.1
    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 18.1
    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 18.1
    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 18.1
    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 assess the efficacy of ocrelizumab 600 mg intravenous (IV) given every 24 weeks on the basis of the following endpoint
    - Proportion of patients who have no evidence of disease activity
    Evaluar la eficacia de ocrelizumab 600 mg por vía intravenosa (IV) administrado cada 24 semanas basándose en el criterio de valoración siguiente:
    - Porcentaje de pacientes sin signos de actividad de la enfermedad
    E.2.2Secondary objectives of the trial
    ? To evaluate the efficacy of ocrelizumab 600 mg IV given every 24 weeks on the basis of the following endpoints
    - Proportions of patients free from a protocol-defined event of disease activity
    - Time to first protocol-defined event of disease activity
    - Change in Expanded Disability Status Scale (EDSS)
    - Proportion of patients who have Confirmed Disability Improvement (CDI), Confirmed Disability Progression (CDP) or stable disability
    - Annualized rate of protocol-defined relapses
    - Time to onset of first protocol-defined relapse, 24 weeks CDP, first new and/or enlarging T2 lesion
    - Total number of T1 Gd-enhanced lesions detected by brain MRI
    - Change in total T2 lesion volume detected by brain MRI
    - Change in T1 hypointense lesions
    - Change in brain volume
    - Change in cognitive performance as measured by the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
    ? To evaluate the safety and tolerability of ocrelizumab 600 mg IV given every 24 weeks
    Evaluar eficacia de ocrelizumab 600 mg por vía intravenosa (IV) administrado cada 24 semanas:
    -% de pacientes sin signos de actividad de la enfermedad conforme episodios definidos en protocolo
    -Tiempo transcurrido hasta primer episodio de actividad de la enfermedad definido en protocolo
    - Variación de la EDSS
    - % pacientes con mejoría confirmada de discapacidad (MCD), progresión confirmada de discapacidad (PCD) o discapacidad estable
    -Tasa anualizada de recidivas definidas en protocolo
    -Tiempo transcurrido hasta comienzo de primera recidiva definida en protocolo, PCD 24 semanas, primera lesión en T2 nueva o aumentada de tamaño
    -Num total de lesiones en T1 realzadas con Gd, detectadas mediante RM cerebral
    -Variación vol total de lesiones en T2 detectadas mediante RM cerebral
    -Variación lesiones hipointensas en T1
    -Variación volumen cerebral
    -Variación rendimiento cognitivo según BICAMS
    -Evaluar eficacia y tolerabilidad de ocrelizumab 600 mg IV administrado cada 24 semanas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-55 years
    - Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria of <= 5 years
    - Have a length of disease duration, from first symptom, of < 10 years
    - Have received no more than two prior disease modifying treatments (DMTs), and the discontinuation of the most recent DMT was due to lack of efficacy
    - Suboptimal disease control while on a DMT
    - EDSS of 0.0 to 4.0, 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
    ? 18 a 55 años de edad
    ? Diagnóstico evidente de EMRR, confirmado según los criterios de McDonald modificados de 2010, desde hace ? 5 años
    ? Enfermedad de < 10 años de duración desde el primer síntoma
    ? Recepción de no más de dos TME previos y suspensión del TME más reciente por falta de eficacia
    ? Control subóptimo de la enfermedad con un TME
    ? EDSS de 0,0 a 4,0, inclusive, en la selección
    ? Mujeres en edad fértil: aceptación del uso de un método anticonceptivo aceptable durante el periodo de tratamiento y durante al menos 6 meses después de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    - Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing MS
    - Inability to complete an MRI
    - Known presence of other neurological disorders
    Exclusions Related to General Health
    - 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
    - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
    - History of opportunistic infections
    - History or known presence of recurrent or chronic infection
    - History of malignancy
    - Congestive heart failure
    - Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
    Exclusions Related to Medications
    - Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
    - Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
    - Contraindications to or intolerance of oral or IV corticosteroids, according to the country label, including a) Psychosis not yet controlled by a treatment; b) Hypersensitivity to any of the constituents
    - Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
    - Systemic corticosteroid therapy within 4 weeks prior to screening
    - Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
    - Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine or methotrexate
    - Previous treatment with natalizumab unless natalizumab was discontinued because of persistent anti-natalizumab antibodies
    - Treatment with IV immunoglobulin (Ig) within 12 weeks prior to baseline
    - Treatment with investigational DMT
    Exclusions Related to Laboratory Findings
    - Positive serum ? human chorionic gonadotropin (hCG) measured at screening
    - Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral DNA polymerase chain reaction [PCR]) or hepatitis C (HepCAb)
    - Lymphocyte count below lower limit of normal (LLN)
    - CD4 count<250/mcL
    - Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT) /serum glutamic pyruvic transaminase (SGPT)=> 3.0 × the upper limit of normal (ULN)
    - Platelet count <100,000/µL (<100 × 109/L)
    - Absolute neutrophil count <1.0 × 103/mcL
    ? Esclerosis múltiple progresiva secundaria (EMPS) o antecedente de EM progresiva primaria o progresiva recidivante
    ? Incapacidad para someterse a una RM
    ? Presencia conocida de otros trastornos neurológicos

    Exclusiones relacionadas con la salud general
    ? Cualquier enfermedad concomitante que requiera tratamiento crónico con corticosteroides o inmunodepresores sistémicos durante el estudio
    ? Inmunodeficiencia primaria o secundaria
    ? Antecedentes de reacciones alérgicas o anafilácticas intensas a anticuerpos monoclonales humanizados o murinos.
    ? Antecedentes de infecciones oportunistas importantes
    ? Antecedente o presencia conocida de infección recurrente o crónica
    ? Antecedente de malignidad
    ? Insuficiencia cardíaca congestiva
    ? Infección bacteriana, viral, fúngica o micobacteriana activa confirmada u otra infección, excluida la infección fúngica de los lechos ungueales

    Exclusiones relacionadas con medicamentos
    ? Recepción de una vacuna de microbios vivos o microbios vivos atenuados 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 cinco semividas del medicamento en investigación (lo que sea más largo) o tratamiento con cualquier procedimiento experimental para la EM (p. ej., tratamiento para la insuficiencia venosa cefalorraquídea crónica)
    ? Intolerancia a los corticosteroides orales o IV o contraindicaciones para recibirlos, según la ficha técnica del país, como:
    a) Psicosis no controlada todavía con un tratamiento;
    b) Hipersensibilidad a cualquiera de los componentes
    ? Administración previa de tratamientos dirigidos a los linfocitos B (es decir, rituximab, ocrelizumab, atacicept, belimumab o ofatumumab)
    ? Tratamiento con corticosteroides sistémicos en las 4 semanas previas a la selección
    ? Cualquier tratamiento previo con alemtuzumab (Campath/Mabcampath/Lemtrada), cladribina, mitoxantrona, daclizumab, laquinimod, irradiación corporal total o trasplante de médula ósea.
    ? Tratamiento con ciclofosfamida, azatioprina, micofenolato mofetilo, ciclosporina o metotrexato
    ? Tratamiento previo con natalizumab a menos que se haya suspendido por anticuerpos persistentes contra este medicamento
    ? Tratamiento con inmunoglobulina (Ig) IV en las 12 semanas previas al momento basal
    ? Tratamiento con TME en investigación

    Exclusiones relacionadas con resultados analíticos
    ? Positividad de la gonadotropina coriónica humana ß (hCG) en suero en la selección
    ? Positividad de las pruebas de detección de la hepatitis B (positividad del antígeno de superficie de la hepatitis B [HBsAg] o del anticuerpo central de la hepatitis B [HBcAb total] confirmada mediante una reacción en cadena de la polimerasa [PCR]) positiva del ADN viral o hepatitis C (HepCAb)
    ? Recuento de linfocitos menor que el LIN
    ? Recuento de CD4 < 250/?l.
    ? Aspartato aminotransferasa (AST)/ transaminasa glutamicooxaloacética (SGOT) en suero o alanina aminotransferasa (ALT) /transaminasa glutamicopirúvica (SGPT) en suero ? 3,0 × límite superior de la normalidad (LSN)
    ? Recuento de plaquetas < 100.000/?l (< 100 × 10^9/l)
    ? Recuento absoluto de neutrófilos < 1,0 × 10^3/?l
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients who have no evidence of disease activity (NEDA), as per protocol defined events during a 96-week period
    1. Porcentaje de pacientes sin episodios definidos en el protocolo hasta la semana 96 (es decir, pacientes sin SSAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 96 weeks
    1. Hasta la semana 96
    E.5.2Secondary end point(s)
    1. Proportions of patients free from a protocol-defined event of disease activity during a 24-week period and a 48-week period
    2. Time to first protocol-defined event of disease activity
    3. Change in EDSS from Baseline to Week 96
    4. Proportion of patients who, over a 96-week period, have CDI, CDP or stable disability
    5. Annualized rate of protocol-defined relapses at Week 96
    6. Time to onset of first protocol-defined relapse
    7. Time to onset of 24 weeks CDP
    8. Time to onset of first new and/or enlarging T2 lesion
    9. Total number of T1 Gd-enhanced lesions detected by brain MRI at Weeks 24, 48 and 96
    10. Change in total T2 lesion volume detected by brain MRI from Baseline to Weeks 24, 48 and 96
    11. Change in T1 hypointense lesions (volume and number) from Baseline to Weeks 24, 48 and 96
    12. Change in brain volume from baseline measured at Weeks 24, 48 and 96
    13. Change from Baseline in cognitive performance at Week 48 and Week 96 as measured by the BICAMS
    14. Incidence of adverse events
    15. Changes in vital signs, physical and neurological examinations, clinical laboratory results, locally reviewed MRI for safety and concomitant medications
    1. Porcentajes de pacientes sin un episodio de actividad de la enfermedad definido en el protocolo durante 24 semanas y 48 semanas
    2. Tiempo transcurrido hasta el primer episodio de actividad de la enfermedad definido en el protocolo
    3. Variación de la EDSS entre el momento basal y la semana 96
    4. Porcentaje de pacientes con mejoría confirmada de la discapacidad (MCD), progresión confirmada de la discapacidad (PCD) o discapacidad estable (es decir, ni MCD ni PCD) durante 96 semanas
    5. Tasa anualizada de recidivas definidas en el protocolo en la semana 96
    6. Tiempo transcurrido hasta el comienzo de la primera recidiva definida en el protocolo
    7. Tiempo transcurrido hasta el comienzo de la PCD a las 24 semanas
    8. Tiempo transcurrido hasta el comienzo de la primera lesión en T2 nueva o aumentada de tamaño
    9. Número total de lesiones en T1 realzadas con Gd, detectadas mediante RM cerebral en las semanas 24, 48 y 96
    10. Variación del volumen total de lesiones en T2 detectadas mediante RM cerebral entre el momento basal y las semanas 24, 48 y 96
    11. Variación de las lesiones hipointensas en T1 (volumen y número) entre el momento basal y las semanas 24, 48 y 96
    12. Variación del volumen cerebral entre el momento basal y las semanas 24, 48 y 96
    13. Variación del rendimiento cognitivo entre el momento basal y las semanas 48 y 96, según la BICAMS (Breve evaluación cognitiva internacional de la esclerosis múltiple)
    14. Incidencia de los acontecimientos adversos
    15. Variaciones de las constantes vitales, las exploraciones físicas y neurológicas, los resultados de los análisis clínicos, la RM revisada localmente para la seguridad y los fármacos concomitantes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. at Weeks 24 and 48
    2. Up to 96 weeks
    3. Baseline and Week 96
    4. Up to 96 weeks
    5. at Week 96
    6-8. Up to 96 weeks
    9. at Weeks 24, 48 and 96
    10-12. Baseline, Weeks 24, 48, and 96
    13. Baseline, Weeks 48, and 96
    14-15. Up to Week 192
    1. En semanas 24 y 48
    2. Hasta 96 semanas
    3. Basal y semana 96
    4. Hasta 96 semanas
    5. En semana 96
    6-8. Hasta 96 semanas
    9. en semanas 24, 48 y 96
    10-12. Basal, semanas 24, 48, y 96
    13. Basal, semanas 48, y 96
    14-15. Hasta semana 192
    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 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) 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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA220
    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
    Belgium
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Ireland
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    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
    Last patient last visit in the B-cell monitoring of the Follow-up Period.
    Ultima visita del último paciente en la vigilancia de los linfocitos B del periodo de seguimiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 months0
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 570
    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 completed the study and decided, in agreement with their treating neurologist, to continue on ocrelizumab treatment can either continue on commercial ocrelizumab if available locally and/or be rolled-over in an separate ocrelizumab LTE study.
    Los pacientes que completen el estudio y que, de acuerdo con el neurólogo que les trate, decidan continuar con el tratamiento de ocrelizumab, podrán continuar con ocrelizumab comercial si está disponible localmente y/o continuar en un estudio de extensión ELP independiente.
    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 Decision2016-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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