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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-004061-41
    Sponsor's Protocol Code Number:101-MS-321
    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:2006-01-16
    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 number2005-004061-41
    A.3Full title of the trial
    Estudio de extensión abierto multicéntrico para evaluar la seguridad y la tolerabilidad de natalizumab después del reinicio de la administración en sujetos con esclerosis múltiple que han completado los estudios C-1801 o C-1802 y una evaluación de la seguridad de suspender la administración
    A.3.2Name or abbreviated title of the trial where available
    STRATA
    A.4.1Sponsor's protocol code number101-MS-321
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIOGEN IDEC LTD
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name TYSABRI
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGEN IDEC INC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameNATALIZUMAB
    D.3.2Product code BG00002
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeBG00002
    D.3.9.3Other descriptive nameAnticuerpo monoclonal recombinante humanizado anti-alpha 4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typeAnticuerpo monoclonal recombinante humanizado anti-alpha 4
    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
    Esclerosis múltiple

    Multiple sclerosis (MS)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Los objetivos principales de este estudio son evaluar con más detalle la seguridad de natalizumab en monoterapia:
    1)Evaluando el riesgo de hipersensibilidad e inmunogenicidad después de reanudar la exposición a natalizumab y
    2) Confirmando la seguridad de cambiar el tratamiento con IFN beta (IFNb), AG u otros fármacos para la EM por natalizumab.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio son examinar:
    1) la viabilidad de un método de detección y diferenciación precoz de la leucoencefalopatía multifocal progresiva (LMP) de la EM en sujetos que presentan signos o síntomas neurológicos nuevos durante el tratamiento con natalizumab
    2) si se pueden utilizar análisis seriados de sangre para vigilar la presencia de virus JC (VJC) en la población con EM y
    3)un método de detección de anticuerpos anti-natalizumab persistentes.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Deben otorgar su consentimiento informado por escrito y todas las autorizaciones exigidas por la legislación local
    2. Deben ser sujetos con EM que hayan completado el estudio C-1801 o C-1802 y haber completado una evaluación de la seguridad de suspender la administración (exploración neurológica y RM)
    3. El investigador debe considerar que no presentan signos ni síntomas que sugieran LMP de acuerdo con la historia clínica, la exploración física o las pruebas de laboratorio
    4. Deben estar dispuestos a suspender y a no recibir tratamiento inmunosupresor o inmunomodulador concomitante (incluido IFNby AG) durante todo el estudio.


    NOTA: si un paciente sufrió un acontecimiento adverso grave (AAG) en los estudios C-1801 o C-1802 y al romper el ciego se descubrió que el recibía placebo, podrá ser incluido en este estudio si completó una evaluación de la seguridad de suspender la administración, recibe la aprobación del director médico de Biogen Idec o del comité asesor competente, cumple todos los demás criterios de inclusión del presente estudio y no es excluido por los criterios de exclusión de este estudio.
    E.4Principal exclusion criteria
    1. Sujeto inmunodeprimido, en opinión del investigador, de acuerdo con la historia clínica, la exploración física o las pruebas de laboratorio o debido a un tratamiento inmunosupresor previo
    2. Antecedentes de anticuerpos persistentes anti-natalizumab, de acuerdo con los análisis realizados en estudios previos de natalizumab
    3. Antecedentes o resultados de laboratorio anómalos disponibles que indiquen cualquier enfermedad importante cardiaca, endocrinológica, hematológica, hepática, inmunológica, metabólica, urológica, pulmonar, gastrointestinal, dermatológica, psiquiátrica (incluida la depresión mayor), renal o de otro tipo, que impida la administración de un inmunomodulador de anticuerpos recombinantes humanizados durante 48 semanas.
    4. Antecedentes de neoplasia maligna (podrán participar los sujetos con carcinoma de células basales completamente extirpado antes de la inclusión en el estudio)
    5. Antecedentes de trasplante de órganos
    6. Antecedentes de reacciones alérgicas o anafilácticas graves o de hipersensibilidad conocida al fármaco
    7. Variación significativa (según el investigador) de la historia médica del sujeto con respecto al anterior estudio con natalizumab
    8. Enfermedad infecciosa clínicamente significativa (p. ej., celulitis, absceso, neumonía, septicemia) en los 30 días previos a la visita de selección del estudio
    9. Suspensión de natalizumab en un estudio previo debido a una reacción alérgica u otro AAG considerado relacionado con el tratamiento de natalizumab
    10. Suspensión del fármaco del estudio en los estudios C-1801 o C-1802 como consecuencia de un AA o por motivos diferentes a una progresión importante de la enfermedad
    11. Mujeres que no lleven 1 año de menopausia como mínimo, que no hayan sido esterilizadas por cirugía (no se incluye la ligadura de trompas) o que no deseen emplear métodos anticonceptivos eficaces (definidos por el investigador) durante el estudio.
    12. Mujeres lactantes, embarazadas o que tengan previsto quedarse embarazadas durante el estudio
    13. Participación actual en cualquier otro estudio sobre tratamientos o enfermedades
    14. Negativa o imposibilidad de cumplir los requisitos de este protocolo, incluida la presencia de cualquier circunstancia (física, mental o social) que pueda afectar a la capacidad del sujeto para cumplir el protocolo.
    15. Cualquier otro motivo no especificado que, en opinión del investigador y/o de Biogen Idec, impida la inclusión del sujeto en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Los objetivos principales de este estudio son evaluar con más detalle la seguridad de natalizumab en monoterapia evaluando el riesgo de hipersensibilidad e inmunogenicidad después de reanudar la exposición a natalizumab y confirmar la seguridad de cambiar el tratamiento con IFNb, AG u otros fármacos para la EM por natalizumab. Todos los análisis se basarán en los datos observados, no se utilizarán métodos de imputación para los datos perdidos.

    La variable de seguridad será la incidencia de acontecimientos adversos. También se evaluará la incidencia del desarrollo de anticuerpos frente a natalizumab.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Fin del estudio = visita telefónica de la semana 52 que es la última visita del último paciente
    Nota: La visita en el centro, en la semana 48 se describe en el protocolo como la visita final del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 900
    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 Decision2006-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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