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    Summary
    EudraCT Number:2018-002145-11
    Sponsor's Protocol Code Number:101MS329
    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:2018-11-05
    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 number2018-002145-11
    A.3Full title of the trial
    A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment
    Estudio en fase IIIb, aleatorizado, controlado, abierto y con enmascaramiento para los evaluadores sobre la eficacia, la seguridad y la tolerabilidad de un intervalo ampliado de 6 semanas de administración de natalizumab (BG00002) en sujetos con esclerosis múltiple recidivante-remitente que anteriormente recibían tratamiento con natalizumab en un intervalo estándar de administración (IEA) de 4 semanas en relación con el tratamiento de IEA continuado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment
    Estudio para evaluar la eficacia, la seguridad y la tolerabilidad de un intervalo ampliado de 6 semanas de administración de natalizumab (BG00002) en sujetos con esclerosis múltiple recidivante-remitente que anteriormente recibían tratamiento con natalizumab en un intervalo estándar de administración (IEA) de 4 semanas en relación con el tratamiento de IEA continuado
    A.4.1Sponsor's protocol code number101MS329
    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.5.6E-mailclinicaltrials@biogen.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 Yes
    D.2.1.1.1Trade name TYSABRI
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    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.3.1Product nameAN100226, 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.3.9.4EV Substance CodeSUB22282
    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.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.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 recidivante-remitente (EMRR)
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of natalizumab extended interval dosing (EID) in
    subjects who have previously been treated with natalizumab standard interval dosing (SID) for at least
    12 months, in relation to continued SID treatment.
    El objetivo principal del estudio es evaluar la eficacia del IAA de natalizumab en sujetos que hayan sido tratados previamente con un IEA de natalizumab durante al menos 12 meses, en relación con un tratamiento de IEA continuado.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate additional clinical and MRI based efficacy endpoints, and safety of
    EID in subjects who have previously been treated with natalizumab SID for at least 12 months, in relation to
    continued SID treatment.
    Evaluar otras medidas de la eficacia clínica basadas en recidivas con un IAA de natalizumab en sujetos que hayan sido tratados previamente con un IEA de natalizumab durante al menos 12 meses, en relación con la continuación del tratamiento con un IEA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ability of the participant to understand the purpose and risks of the study and provide signed and dated
    informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
    • Diagnosis of relapsing remitting multiple sclerosis (RRMS) according to the McDonald criteria [Thompson
    2018].
    • Treatment with natalizumab as disease-modifying monotherapy for RRMS that is consistent with the
    approved dosing for a minimum of 12 months prior to randomization. The participant must have received at
    least 11 doses of natalizumab in the 12 months prior to randomization with no missed doses in the 3 months
    prior to randomization.
    • Expanded Disability Status Scale (EDSS) <=5.5 at screening.
    • No relapses in the last 12 months prior to randomization, as determined by the enrolling Investigator

    NOTE: Other protocol-defined inclusion criteria may apply.
    • Capacidad del sujeto de comprender el propósito y los riesgos del estudio y proporcionar el consentimiento informado firmado y fechado así como la autorización para usar información médica de acuerdo con la normativa nacional y local sobre la privacidad de los sujetos.
    • Diagnóstico de EMRR según los criterios de McDonald [Thompson 2018].
    • Tratamiento con natalizumab como monoterapia modificadora de la enfermedad para la EMRR y con una dosis coherente con la administración aprobada durante un mínimo de 12 meses antes de la aleatorización. El sujeto debe haber recibido un mínimo de 11 dosis de natalizumab en los 12 meses anteriores a la aleatorización y no haber omitido ninguna dosis en los 3 meses anteriores a la aleatorización.
    • EDSS ≤5,5 en la selección.
    • Sin recidivas en los 12 últimos meses anteriores a la aleatorización, según lo determinado por el investigador que realiza la inscripción.

    NOTA: Otros criterios de inclusion definidos en el protocolo podrian aplicar
    E.4Principal exclusion criteria
    • Primary and secondary progressive multiple sclerosis (MS).
    • MRI positive for Gd-enhancing lesions at screening.
    • Participants for whom MRI is contraindicated (e.g., have a contraindicated pacemaker or other contraindicated implanted metal device, have suffered, or are at risk for, side effects from Gd, or have claustrophobia that cannot be medically managed).
    • History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical
    study, in the opinion of the Investigator.
    • Presence of anti-natalizumab antibodies at screening.

    NOTE: Other protocol-defined exclusion criteria may apply.
    • EM progresiva primaria y secundaria.
    • RM positiva para lesiones potenciadas con Gd en la selección.
    • Los sujetos para los que la RM está contraindicada (p. ej., llevan un marcapasos contraindicado u otros implantes metálicos contraindicados, han sufrido o presentan riesgo de sufrir efectos secundarios con Gd o padecen claustrofobia que no se puede controlar médicamente).
    • Antecedentes de cualquier enfermedad cardíaca, endocrinológica, hematológica, hepática, inmunitaria, metabólica (incluido la diabetes), urológica, pulmonar, neurológica (excepto la EMRR), dermatológica, psiquiátrica, renal u otra enfermedad importante clínicamente significativa (según lo determinado por el investigador) que impida participar en un estudio clínico, en opinión del investigador.
    • Presencia de anticuerpos contra natalizumab en la selección.

    NOTA: Otros criterios de inclusion definidos en el protocolo podrian aplicar
    E.5 End points
    E.5.1Primary end point(s)
    Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 48
    Número de lesiones hiperintensas en T2 nuevas o que hayan aumentado de tamaño en la semana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    •Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC)
    •Number of new Gadolinium (Gd) Enhancing and new T1 Hypointense Lesions at Weeks 24, 48 and 72
    •Annualized Relapse Rate at Weeks 48 and 72
    •Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 72
    •Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    o Tiempo hasta la primera recidiva (las recidivas serán adjudicadas por un comité independiente de evaluación neurológica)
    o Número de nuevas lesiones hipointensas en T1 y de nuevas lesiones potenciadas con gadolinio (Gd) en las semanas 24, 48 y 72
    o Número de lesiones hiperintensas en T2 nuevas o que hayan aumentado en la semana 24 y la semana 72
    o Evaluaciones de seguridad de los acontecimientos adversos y acontecimientos adversos graves
    E.5.2.1Timepoint(s) of evaluation of this end point
    Variable time frames throughout the study
    Marcos de tiempo variables a lo largo 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 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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Israel
    Italy
    Netherlands
    New Zealand
    Spain
    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
    LVLS
    LPLV
    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 months2
    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 months2
    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: 480
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 480
    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)
    There is no provision to provide study treatment after the study. Natalizumab is available
    commercially and subjects/Investigators can continue Tysabri treatment via a commercial
    source.
    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 Decision2019-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-26
    P. End of Trial
    P.End of Trial StatusOngoing
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