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    EudraCT Number:2010-021978-11
    Sponsor's Protocol Code Number:101MS326
    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:2011-09-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-021978-11
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo de la eficacia de natalizumab para reducir la progresión de la incapacidad en pacientes con esclerosis múltiple secundaria progresiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS
    Estudio de la eficacia de natalizumab para reducir la progresión de la incapacidad en pacientes con esclerosis múltiple secundaria progresiva
    A.4.1Sponsor's protocol code number101MS326
    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 SponsorBiogen Idec Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Limited
    B.5.2Functional name of contact pointNot available
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    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 Yes
    D. name Tysabri
    D. of the Marketing Authorisation holderElan Pharma International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code AN100226, BG00002
    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 INNNATALIZUMAB
    D.3.9.1CAS number 189261-10-7
    D.3.9.3Other descriptive nameSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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
    Secondary Progressive Multiple Sclerosis
    Esclerosis Múltiple Secundaria Progresiva
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Esclerosis Múltiple
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    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
    The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS.
    El objetivo principal del estudio es investigar si el tratamiento con natalizumab retrasa la progresión de la discapacidad no relacionada con recidivas en sujetos con EMSP.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine in this study population:
    ? the proportion of subjects with consistent improvement in Timed 25-foot Walk (T25FW)
    ? the change in subject-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12)
    ? the change in manual ability based on the ABILHAND Questionnaire
    ? the impact of natalizumab on subject-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical)
    ? the change in whole brain brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI)
    ? the proportion of subjects experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores
    Los objetivos secundarios de este estudio consisten en determinar en la población de estudio:
    ? la proporción de sujetos que presentan mejoras constantes en la marcha de 25-pasos cronometrada (T25FW)
    ? el cambio en el estado ambulatorio notificado por el sujeto, medido por la escala de 12 ítems para evaluar la marcha en la EM (MSWS-12)
    ? el cambio en la habilidad manual basado en el cuestionario ABILHAND
    ? el impacto de natalizumab sobre la calidad de vida notificada por el sujeto, medido por la escala de 29 ítems que evalúa el impacto de la esclerosis múltiple sobre el estado físico (MSIS-29 impacto físico)
    ? el cambio en el volumen cerebral total entre el final del estudio y la semana 24, medido mediante una resonancia magnética (RM)
    ? la proporción de sujetos que experimentan progresión de la discapacidad, medida por la puntuación individual de la escala ampliada del estado de discapacidad (EDSS) a nivel físico
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies are detailed in main protocol , version 2 Final dated 29 June 2011, section 13.5.
    The substudies to be performed in any of the involved countries are as follows:
    - CSF Concentrations of Natalizumab and Inflammatory Markers: US, Canada, UK, Sweden, Denmark, Poland and Germany
    - Cognition: Australia, Canada, Italy, Spain, UK, US
    - Genetic Analysis: in all the countries after patient consent.
    Los subestudios se detallan en el protocolo principal, version final de fecha 29 de Junio de 2011, sección 13.5. Los subestudios que se llevaran a cabo en los paises involucrados son:
    - Concentraciones de natalizumab y marcadores inflamatorios en LCR: EEUU, Canadá, Reino Unido, Suecia, Dinamarca, Polonia y Alemania
    - Cognición: Australia, Canadá, Italia, España, Reino Unido, EEUU
    - Análisis de ADN: En todos los paises tras la obtención del consentimiento del paciente.
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization (Day 0), or at the timepoint specified in the individual eligibility criterion listed:
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Be between the ages of 18 and 58, inclusive, at the time of informed consent.
    3. Onset of SPMS at least 2 years prior to enrollment. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by MS relapses (Lublin, Reingold, 1996) ) for at least 2 years.
    4. Have EDSS score of 3.0 to 6.5, inclusive.
    5. Have an MS Severity Score (MSSS) of 4 or higher.
    6. Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment as defined in the Study Reference Guide.
    7. Subjects must have completed those baseline assessments associated with components of the primary endpoint (EDSS, T25FW, 9HPT) prior to randomization (Day 0).
    8. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last infusion.
    Para ser considerado aptos para participar en este estudio, los candidatos deben cumplir los siguientes criterios de elegibilidad en el momento de la aleatorización (día 0) o en el punto temporal especificado en los criterios de elegibilidad individuales enumerados:
    1. Capacidad de comprender la finalidad y los riesgos del estudio y proporcionar un consentimiento informado firmado y fechado y una autorización para usar la información médica protegida (IMP) de acuerdo a las normas locales sobre la privacidad de los sujetos.
    2. Tener entre 18 y 58 años de edad, ambos inclusive, en el momento del consentimiento informado.
    3. Aparición de EMSP desde hace al menos 2 años previa a la inscripción. EMPP definida como una enfermedad remitente-recidivante seguida de una progresión de la discapacidad independiente o no explicada por las recidivas de la EM (Lublin, Reingold, 1996) durante al menos 2 años.
    4. Tener una puntuación de entre 3,0 y 6,5, ambos inclusive, en la escala EDSS.
    5. Tener una puntuación de 4 o más en la Escala de gravedad de la EM (MSSS).
    6. Tener evidencia documentada y confirmada de la progresión de la enfermedad independiente de las recidivas clínicas a lo largo de 1 año antes de la inscripción en el estudio, según se define en la Guía de referencia del estudio.
    7. Los sujetos deben haber realizado esas evaluaciones iniciales asociadas con componentes del criterio principal de valoración (EDSS, T25FW, 9HPT) antes de la aleatorización (Día 0).
    8. Las participantes con capacidad reproductiva deben utilizar métodos anticonceptivos eficaces durante el estudio y estar dispuestas a continuar utilizando métodos anticonceptivos durante 3 meses después de la última infusión
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of randomization (Day 0), or at the timepoint specified in the individual criterion listed:
    1.Have a diagnosis of RRMS or primary progressive MS as defined by the revised McDonald Committee criteria (Polman et al 2005).
    2. Had a recent clinical relapse (within 3 months) prior to randomization.
    3. Have a T25FW test of >30 seconds during the screening period.
    4. Any value below the lower limit of normal for blood levels of leukocytes, lymphocytes, or neutrophils.
    5. Considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or any other testing required by local guidelines, or due to prior immunosuppressive or immunomodulating treatment.
    6. Subjects for whom MRI is contraindicated (i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed).
    7. History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical study.
    8. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
    9. Known history of or positive test result for Human Immunodeficiency Virus (HIV).
    10. Positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
    11. History of transplantation or any anti-rejection therapy.
    12. Presence of any infectious disease (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to screening.
    13. History of PML or other opportunistic infections including active tuberculosis.

    Treatment History
    14. Any prior treatment with cell-depleting therapies, including total lymphoid irradiation, cladribine, rituximab, alemtuzumab, or bone marrow ablation.
    15. Any prior treatment with natalizumab.
    16. Treatment with mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, T cell or T cell receptor vaccination, fingolimod, daclizumab, or cytapheresis within 6 months prior to randomization.
    17. Treatment with IV or oral corticosteroids, intravenous immunoglobulin (IVIg), or plasmapheresis for treatment of MS within the 3 months prior to randomization.
    18. Treatment with glatiramer acetate or any interferon beta preparations within 4 weeks prior to randomization.
    19. Treatment with 4-aminopyridine within 30 days prior to randomization, unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study.

    20. Female subjects considering becoming pregnant while in the study.
    21. Female subjects of childbearing potential who have a positive pregnancy test at either the Screening Visit or Week 0.
    22. Female subjects who are pregnant or currently breastfeeding.
    23. History of drug or alcohol abuse, in the opinion of the Investigator, within 2 years prior to entry.
    24. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
    25. Participation in any other investigational treatment study within the 3 months prior to screening or concurrent with this study.
    26. Any pre-scheduled elective procedure during the study period that, in the opinion of the Investigator, would interfere with study parameters.
    27. Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study.
    28. Previous participation in this study.
    Los candidatos serán excluidos del estudio si existe alguno de los siguientes criterios de exclusión en el momento de la aleatorización (día 0) o en el punto temporal especificado en los criterios individuales enumerados:
    1. Habérseles diagnosticado EMRR o EM primaria progresiva, definida según los criterios del Comité de McDonald (Polman et al.2005). 2. Haber tenido una recidiva clínica reciente (hace menos de 3 meses) antes de la aleatorización.
    3. Tener una prueba de T25FW >30 segundos durante el periodo de selección.
    4. Cualquier valor por debajo del límite inferior de la normalidad para los niveles sanguíneos de leucocitos, linfocitos o neutrófilos.
    5. Que el investigador considere que el sujeto está inmunocomprometido basándose en el historial médico, la exploración física, las pruebas de laboratorio o cualquier otra prueba requerida por las directrices locales, o debido a un tratamiento inmunosupresor o inmunomodulador previo.
    6. Sujetos en los que está contraindicado la realización de RM (p. ej., portadores de marcapasos o otros dispositivos metálicos implantados en los que esté contraindicada, sujetos alérgicos al gadolinio o que padezcan claustrofobia que no se pueda controlar médicamente).
    7. Antecedentes de cualquier afección clínicamente significativa (a criterio del investigador) de tipo cardiaco, endocrino, hematológico, hepático, inmunológico, metabólico, urológico, pulmonar, neurológico (aparte de EM), dermatológico, psiquiátrico y renal, o cualquier otra enfermedad importante que impediría la participación en un estudio clínico.
    8. Antecedentes de neoplasias malignas, incluidos tumores sólidos y hematológicos (con la excepción de carcinomas cutáneos de células basales y células escamosas que hayan sido extirpados completamente y estén considerados como curados).
    9. Antecedentes conocidos de un resultado positivo en la prueba del virus de la inmunodeficiencia humana (VIH).
    10. Resultado positivo en la prueba del virus de la hepatitis C (prueba del anticuerpo del virus de la hepatitis C [HCV ab]) o del virus de la hepatitis B (prueba del antígeno de superficie de la hepatitis B [HBsAg] y/o anticuerpo del núcleo de la hepatitis B [HBcAb]).
    11. Antecedentes de trasplantes o de cualquier terapia antirrechazo.
    12. Presencia de cualquier enfermedad infecciosa (p. ej., celulitis, absceso, neumonía, septicemia) en los 30 días previos a la selección.
    13. Antecedentes de LMP o de cualquier otra infección oportunista incluida la tuberculosis activa.
    Antecedentes de tratamiento
    14. Cualquier tratamiento previo con terapias de reducción del número de células, incluidas irradiación linfoide total, cladribina, rituximab, alemtuzumab o ablación de la médula ósea.
    15. Cualquier tratamiento previo con natalizumab 16. Tratamiento con mitoxantrona, ciclofosfamida, ciclosporina, azatioprina, metotrexato, micofenolato de mofetilo, vacuna de linfocitos T o de receptor de linfocitos T, fingolimod, daclizumab o citaféresis en los 6 meses previos a la aleatorización.
    17. Tratamiento con corticosteroides IV u orales, inmunoglobulina intravenosa (IVIg) o plasmaféresis para el tratamiento de la EM en los 3 meses previos a la aleatorización.
    18. Tratamiento con acetato de glatiramer o cualquier preparación de interferón beta en las 4 semanas previas a la aleatorización.
    19. Tratamiento con 4-aminopiridina en los 30 días previos a la aleatorización, salvo que se haya mantenido una dosis estable durante al menos 30 días antes de la aleatorización y se vaya a continuar para toda la duración del estudio.
    20. Mujeres que estén considerando quedarse embarazadas durante su participación en el estudio.
    21. Mujeres con capacidad reproductiva con resultado positivo en la prueba de embarazo en la visita de selección o la Semana 0.
    22. Mujeres embarazadas o en periodo de lactancia.
    23. Antecedentes de abuso de drogas o alcohol, en opinión del investigador, en los 2 años previos a la inscripción.
    24. Falta de voluntad o incapacidad para cumplir con los requisitos de este protocolo, lo que incluye la presencia de cualquier afección (física, mental o social) que probablemente afecte la capacidad del sujeto para cumplir con el protocolo del estudio.
    25. Participación en cualquier otro estudio de tratamiento experimental en los 3 meses previos a la selección o concurrente con este estudio.
    26. Cualquier procedimiento electivo preprogramado durante el periodo del estudio que, en opinión del investigador, pueda interferir con los parámetros del estudio.
    27. Cualquier otra afección, hallazgo clínico o motivo que, en opinión del investigador, se considere inadecuada para la inscripción en este estudio.
    28. Participación previa en este estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a binary outcome of confirmed progressors or non-progressors of disability, where progressors are defined as subjects who meet at least one of the
    following criteria:

    ? Confirmed progression in EDSS: EDSS score increased from baseline by at least
    1 point if baseline EDSS ?5.5 or by at least 0.5 points if baseline EDSS ?6,
    confirmed at a second visit at least 6 months later
    ? Confirmed progression in T25FW: Time taken for T25FW increased by at least
    20% of the baseline walk, confirmed at a second visit at least 6 months later
    ? Confirmed progression in 9HPT: Time taken for 9HPT increased by at least 20%
    of the time taken at baseline, confirmed at a second visit at least 6 months later.
    The progression in 9HPT can occur on either hand, but will have to be confirmed
    on the same hand.
    El criterio de valoración primario es un resultado binario de los sujetos con progresión de la discapacidad confirmada o sujetos sin progresión; se definen como sujetos con progresión aquellos que cumplen al menos uno de los siguientes criterios:
    ? Progresión confirmada en EDSS: La puntuación de EDSS aumentó desde el inicio del estudio en al menos 1 punto si la puntuación de EDSS al inicio era ?5,5 o al menos 0,5 puntos si la puntuación de EDSS al inicio era ?6, confirmado en una segunda visita al menos 6 meses después
    ? Progresión confirmada en T25FW: Tiempo que tardó en hacer la prueba T25FW aumentado por al menos un 20% de la marcha al inicio del estudio, confirmado en una segunda visita al menos 6 meses después
    ? Progresión confirmada en 9HPT: Tiempo que tardó hacer la prueba 9HPT aumentado por al menos un 20% desde el tiempo que tardó al inicio del estudio, confirmado en una segunda visita al menos 6 meses después. La progresión en 9HPT puede producirse en cualquier mano, pero deberá confirmarse en la misma mano
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 month intervals
    en intervalos de 6 meses
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are as follows:
    ? Percentage of T25FW responders (defined as any improvement from best pre-dose T25FW in at least 75% of the scheduled on-treatment visits through Week 96).
    ? Change from baseline in MSWS-12 score to Week 96.
    ? Change from baseline in ABILHAND Questionnaire scores to Week 96.
    ? Change from baseline in MSIS-29-Physical score to Week 96.
    ? Percentage change from Week 24 in whole brain volume at Week 96.
    ? Percentage of subjects experiencing confirmed worsening in the individual EDSS Physical Functional System Scores where confirmed is defined as 2 examinations at least 6 months apart
    Los criterios de valoración secundarios de este estudio son los siguientes:
    ? Porcentaje de respondedores de T25FW (definido como cualquier mejora desde el mejor registro de T25FW antes de la dosis en al menos un 75% de las visitas programadas con tratamiento hasta la semana 96).
    ? Cambio desde el inicio del estudio en la puntuación de MSWS-12 hasta la semana 96.
    ? Cambio desde el inicio del estudio en las puntuaciones del cuestionario de ABILHAND hasta la semana 96.
    ? Cambios desde el inicio del estudio en la puntuación del MSIS-29 impacto físico hasta la semana 96 ? Cambio porcentual desde la semana 24 en el volumen cerebral total en la semana 96.
    ? Porcentaje de sujetos que experimentan un agravamiento confirmado de las puntuaciones individuales del sistema funcional físico de la EDSS, en donde confirmado se define como 2 exploraciones físicas separadas por al menos 6 meses
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Percentage of T25FW responders (defined as any improvement from best predose
    T25FW in at least 75% of the scheduled on-treatment visits through Week
    96) (every 3 months)

    ? Change from baseline in MSWS-12 score to Week 96 (every 3 months)

    ? Change from baseline in ABILHAND Questionnaire scores to Week 96 (every 3 months)

    ? Change from baseline in MSIS-29-Physical score to Week 96 (every 6 months)

    ? Percentage change from Week 24 in whole brain volume at Week 96 (every 6 months)

    ? Percentage of subjects experiencing confirmed worsening in the individual EDSS Physical Functional System Scores where confirmed is defined as 2 examinations
    at least 6 months apart (6 month intervals)
    Porcentaje de respondedores a T25FW (Un respondedor a T25FW se define como un sujeto que tarda menos tiempo en caminar 25 pasos en comparación con el tiempo más corto que le llevó antes de la dosis en al menos el 75% de las evaluaciones de T25FW bajo tratamiento a lo largo de 96 semanas) (cada 3 meses)
    Cambio en MSWS-12 desde el inicio del estudio hasta la semana 96 (cada 3 meses)
    Cambio en la puntuación del cuestionario ABILHAND desde el inicio del estudio hasta la semana 96 (cada 3 meses)
    Cambio en el cuestionario MSIS-29 impacto físico desde el inicio del estudio hasta la semana 96 (cada 6 meses)
    Por favor, vease protocolo
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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.8.2.4Number of treatment arms in the trial2
    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 concerned80
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA126
    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
    Czech Republic
    Russian Federation
    United Kingdom
    United States
    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
    The end of study is last subject, last visit for final collection of data.
    El fin de estudio es la última visita del último sujeto para la recogida final de datos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 856
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 506
    F.4.2.2In the whole clinical trial 856
    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)
    All subjects who complete this study according to the protocol and who are eligible may choose to be enrolled into an open label extension study in which all subjects will receive natalizumab. This extension study will be described under a separate protocol.
    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 Decision2011-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-13
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