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    Summary
    EudraCT Number:2013-000594-69
    Sponsor's Protocol Code Number:211LE202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-03-17
    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 number2013-000594-69
    A.3Full title of the trial
    A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects with Lupus Nephritis
    Estudio de extensión a largo plazo, multicéntrico, en grupos paralelos, con enmascaramiento de la dosis y dos niveles posológicos, para evaluar la seguridad, la eficacia y la inmunogenicidad de BIIB023 a largo plazo en sujetos con nefritis lúpica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Extension Study of BIIB023 in Subjects with Lupus Nephritis
    Estudio de extensión a largo plazo de BIIB023 en sujetos con nefritis lúpica
    A.3.2Name or abbreviated title of the trial where available
    Unknown
    A.4.1Sponsor's protocol code number211LE202
    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 Research 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 Research 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 Research 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, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34 91310 7166--
    B.5.6E-mailimmunologyclinicaltrials@biogenidec.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 nameBIIB023
    D.3.4Pharmaceutical form Solution for injection/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 INNNot Available
    D.3.9.2Current sponsor codeBIIB023
    D.3.9.3Other descriptive nameAnti-TWEAK monoclonal antibody BIIB023
    D.3.9.4EV Substance CodeSUB31986
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.IMP: 2
    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.2.1.1.1Trade name CellCept (mycophenolate mofetil)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.1CAS number 115007-34-6
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus Nephritis
    Nefritis Lúpica
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis
    Nefritis Lúpica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary 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 evaluate the long-term safety and tolerability of BIIB023 in subjects with LN.
    El objetivo principal del estudio es evaluar la seguridad y la tolerabilidad a largo plazo de BIIB023 en sujetos con NL.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are as follows:
    -To evaluate the long-term efficacy of BIIB023 in subjects with LN - To evaluate the long-term immunogenicity of BIIB023 in subjects with LN
    -To evaluate the long-term pharmacokinetics (PK) of BIIB023 in subjects with LN
    Los objetivos secundarios de este estudio son los siguientes:
    ? Evaluar la eficacia a largo plazo de BIIB023 en sujetos con NL.
    ? Evaluar la inmunogenicidad a largo plazo de BIIB023 en sujetos con NL.
    ? Evaluar la farmacocinética (FC) a largo plazo de BIIB023 en sujetos con NL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at Baseline (Day 1) 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 in accordance with national and local subject privacy regulations.
    2. Subjects who completed Week 52 of Study 211LE201 and did not discontinue BIIB023 or placebo study treatment.
    3. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.
    Para ser elegibles para participar en este estudio, los candidatos deben cumplir los siguientes criterios de elegibilidad al inicio (día 1) o en el punto temporal especificado en el criterio de elegibilidad individual indicado:
    1. Capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado firmado y fechado y la autorización para usar información sanitaria protegida de acuerdo con la normativa nacional y local sobre la privacidad de los sujetos.
    2. Sujetos que completaron la semana 52 del estudio 211LE201 sin interrumpir el tratamiento del estudio con BIIB023 o con placebo.
    3. Los sujetos en edad fértil deben tomar medidas anticonceptivas eficaces durante el estudio, así como estar dispuestos y ser capaces de continuar con estas durante los 6 meses posteriores a su última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at Baseline (Day 1) or at the timepoint specified in the individual criterion listed:

    1. Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects? participation. The Investigator must re-review the subject?s medical fitness for participation and consider any diseases that would preclude treatment under this protocol.
    2. Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
    3. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
    4. Previous participation in Study 211LE202; subjects who were enrolled in Study 211LE202 and consequently withdrew for any reason are prohibited from re-entering the study.
    5. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject?s ability to comply with the protocol.
    6. Subjects who were prescribed MMF >3 g/day during Study 211LE201 and/or subjects for whom the Investigator is planning to prescribe MMF >3 g/day during this study.
    7. Subjects having received disallowed concomitant medication during Study 211LE201 including the following:
    a. Immunosuppressant used for therapy of LN (cyclophosphamide, nitrogen mustard, chlorambucil, vincristine, procarbazine, etoposide, mycophenolic acid, azathioprine, cyclosporine, methotrexate, atacicept, or any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], or anti-BLyS/B-cell activating factor [e.g., belimumab] therapy).
    b. Treatment with Campath (alemtuzumab)
    c. Anti-tumor necrosis factor (infliximab, adalimumab, etanercept, efalizumab or alefacept) treatment
    d. Cyclophosphamide, calcineurin, or a calcineurin inhibitor (i.e., cyclosporine A or tacrolimus)
    8. Subjects with the following laboratory test results at Week 48 of Study 211LE201:
    a. Absolute neutrophil count <1.5 × 1000/?L
    b. Platelet count <20,000/?L; subjects with platelet count >20,000/?L and <150,000/?L who are experiencing, or at high risk for developing, clinically significant bleeding or organ dysfunction requiring therapy (as determined by the Investigator)
    c. Hemoglobin <8.5 g/dL
    d. Aspartate aminotransferase/serum glutamate oxaloacetate transaminase or alanine aminotransferase/serum glutamate pyruvate transaminase >2 × upper limit of normal established by the central laboratory
    9. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, makes the subject unsuitable for enrollment.
    Los candidatos serán excluidos del estudio si cumplen con alguno de los siguientes criterios de exclusión al inicio (día 1) o en el punto temporal especificado en el criterio individual indicado:
    1. Cualquier cambio significativo en el historial médico de los sujetos del estudio 211LE201, incluidas las pruebas de laboratorio, o una afección actual clínicamente significativa que, en la opinión del investigador, habría excluido al sujeto de participar en el estudio. El investigador debe volver a revisar el estado médico del sujeto para poder participar y considerar cualquier enfermedad que pudiera impedir el tratamiento según este protocolo.
    2. Los sujetos del estudio 211LE201 que interrumpieron el tratamiento con BIIB023 o placebo antes de la semana 52 del estudio 211LE201.
    3. Sujetos del sexo femenino que se estén planteando quedarse embarazadas durante el estudio, que estén actualmente embarazadas o en periodo de lactancia.
    4. Participación previa en el estudio 211LE202; los sujetos que estuvieron inscritos en el estudio 211LE202 y posteriormente se retiraron por cualquier motivo tienen prohibido volver a entrar en el estudio.
    5. Falta de disposición o incapacidad por parte del sujeto de cumplir con los requisitos del protocolo, incluida la presencia de cualquier enfermedad (física, mental o social) que probablemente pueda afectar a la capacidad del sujeto de cumplir con el protocolo del estudio.
    6. Sujetos a los que se recetó MMF > 3 g/día durante el estudio 211LE201 y/o sujetos a los que el investigador tiene planeado recetar MMF > 3 g/día durante este estudio.
    7. Sujetos que han recibido medicación concomitante no permitida durante el estudio 211LE201, que incluye:
    a. Inmunosupresores utilizados para el tratamiento de la NL (ciclofosfamida, mostaza nitrogenada, clorambucilo, vincristina, procarbazina, etopósido, ácido micofenólico, azatioprina, ciclosporina, metotrexato, atacicept), o cualquier tratamiento biológico que cause depleción de linfocitos B (p. ej., anti-CD20 [rituximab], anti-CD22 [epratuzumab], o tratamiento con anti-BLyS/factor de activación de linfocitos B [p. ej., belimumab]).
    b. Tratamiento con Campath (alemtuzumab).
    c. Tratamiento antifactor de necrosis tumoral (infliximab, adalimumab, etanercept, efalizumab o alefacept).
    d. Ciclofosfamida, calcineurina, o inhibidor de la calcineurina (es decir, ciclosporina A o tacrolimus).
    8. Sujetos con los siguientes resultados de las pruebas de laboratorio de la semana 48 del estudio 211LE201:
    a. Recuento absoluto de neutrófilos < 1,5 × 103/?l.
    b. Recuento plaquetario < 20.000/?l; sujetos con recuento plaquetario > 20.000/?l y < 150.000/?l que padecen o tienen un elevado riesgo de desarrollar hemorragia clínicamente significativa o disfunción orgánica que requiera tratamiento (según lo determinado por el investigador).
    c. Hemoglobina < 8,5 g/dl.
    d. Aspartato aminotransferasa/transaminasa glutámico-oxalacética sérica o alanina aminotransferasa/transaminasa glutámico-pirúvica sérica > 2 x límite superior de la normalidad establecido por el laboratorio central.
    9. Otras razones no especificadas que, en opinión del investigador o de Biogen Idec, hagan que el sujeto no sea apto para la inscripción.
    E.5 End points
    E.5.1Primary end point(s)
    -Incidence of adverse events (AEs) and serious adverse events (SAEs)
    -Discontinuation of study treatment or withdrawal from the study due to an AE
    - Incidencia de acontecimiento adverso (AA) y acontecimiento advierso grave (AAG)
    - Interrupcion del tratamiento o retirada del estudio debido a un acontecimiento adverso
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 108 and throughout the duration of study
    Semana 108 y a lo largo de la duración del estudio
    E.5.2Secondary end point(s)
    -Proportion of subjects who develop antibodies to BIIB023 -Incidence of partial renal response
    -Incidence of complete renal response
    -Time to complete renal response in subjects without complete renal response at baseline
    -Duration of renal response
    -Proportion of subjects who experience a new renal flare
    -Time to renal flare
    -Time to first non-renal systemic lupus erythematosus (SLE) flare
    -Time to a major adverse renal event defined as the occurrence of one of the following:
    a. New renal flare during the Dose-Blinded
    -Treatment Period
    a. Sustained doubling (present in 2 consecutive visits at least 4 weeks apart) of serum creatinine from Baseline (Day 1)
    b. Initiation of rescue therapy for LN
    c. End-stage renal disease
    d. Death from any cause
    -Changes in SLE index: Safety of Estrogens in Lupus Erythematosus-National Assessment Systemic Lupus Erythematosus Disease Activity Disease Activity Index (SELENA-SLEDAI) and Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR)
    a. Steroid use
    b. (Mycophenolate mofetil) MMF use
    c. PK assessments
    ? Proporción de sujetos que desarrollan anticuerpos de BIIB023.
    ? Incidencia de respuesta renal parcial.
    ? Incidencia de respuesta renal completa.
    ? Tiempo hasta completar la respuesta renal en sujetos sin respuesta renal completa al inicio.
    ? Duración de la respuesta renal.
    ? Proporción de sujetos que sufren una nueva exacerbación renal.
    ? Tiempo hasta la exacerbación renal.
    ? Tiempo hasta la primera exacerbación no renal de LES.
    ? Tiempo hasta un acontecimiento adverso renal importante definido como la ocurrencia de uno de los siguientes:
    - Nueva exacerbación renal durante el periodo de tratamiento con enmascaramiento de la dosis.
    - Duplicación sostenida (presente en 2 visitas consecutivas con un mínimo de 4 semanas de separación) de la creatinina sérica desde el inicio (día 1).
    - Inicio del tratamiento de rescate para la NL.
    - ERT.
    - Muerte por cualquier causa.
    ? Cambios en el índice LES: Evaluación nacional de seguridad de los estrógenos en lupus eritematoso - Índice de actividad del lupus eritematoso sistémico (SELENA-SLEDAI) y Clínicas colaboradoras a nivel internacional en el lupus sistémico / Sociedad Estadounidense de Reumatología (SLICC/ACR).
    ? Uso de esteroides.
    ? Uso de MMF.
    ? Evaluaciones de FC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 108 and/or throughout the duration of study
    Semana 108 y a lo largo de la duración del estudio
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Multicéntrico, en grupos paralelos, con enmascaramiento de la dosis y dos niveles posológicos
    Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Canada
    China
    France
    Italy
    Portugal
    Argentina
    Australia
    Brazil
    Colombia
    Germany
    Hong Kong
    Hungary
    Korea, Republic of
    Malaysia
    Spain
    Thailand
    Israel
    Mexico
    Peru
    Philippines
    Poland
    Russian Federation
    Serbia
    South Africa
    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
    Last subject, last visit
    Ultimo paciente, Ultima visita
    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 months11
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months12
    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: 209
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 220
    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)
    No further provisions are made for access to the study treatment under this protocol. If BIIB023 is proven to be beneficial, all regulatory requirements regarding poststudy access will be met.
    No hay disposiciones adicionales para el acceso al tratamiento del estudio bajo este protocolo. Si BIIB023 ha demostrado ser beneficioso, se cumplirán todos los requisitos reglamentarios en materia de acceso al estudio posterior
    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 Decision2014-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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