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    Summary
    EudraCT Number:2009-010788-18
    Sponsor's Protocol Code Number:CAMMS03409
    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:2010-01-08
    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 number2009-010788-18
    A.3Full title of the trial
    Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.
    A.4.1Sponsor's protocol code numberCAMMS03409
    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 SponsorGenzyme Corporation
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name MABCAMPATH 10 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderGENZYME EUROPE, BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNALEMTUZUMAB
    D.3.9.3Other descriptive nameALEMTUZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.8Extractive medicinal product No
    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 Humanizado
    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 Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    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 de este estudio son evaluar: (1) la seguridad y la eficacia a largo plazo de alemtuzumab en pacientes con esclerosis múltiple (EM) que recibieron este fármaco en estudios previos patrocinados por Genzyme, incluidos los estudios CAMMS223, CAMMS323 o CAMMS32400507 (en adelante CAMMS324); (2) la seguridad y la eficacia de la repetición del tratamiento con alemtuzumab según las necesidades en estos pacientes tratados previamente con este fármaco y (3) la seguridad y la eficacia de 2 ciclos anuales fijos de alemtuzumab seguidos por la repetición opcional del tratamiento según las necesidades en pacientes que previamente recibieron interferón beta-1a subcutáneo (IFNb-1a SC) durante estos estudios
    E.2.2Secondary objectives of the trial
    También se evaluará la eficacia del tratamiento inmediato con alemtuzumab (TIA, es decir, alemtuzumab iniciado al comienzo del estudio CAMMS323 o CAMMS324) frente al tratamiento retrasado con alemtuzumab (TRA, es decir, alemtuzumab iniciado después de completar 2 años de los estudios CAMMS323 o CAMMS324).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes deben cumplir UNO de los siguientes criterios para participar en este estudio de extensión:
    1.Haber recibido alemtuzumab en los estudios CAMMS323 o CAMMS324, haber completado el periodo de 2 años de estudio y NO haber recibido posteriormente tratamientos modificadores de la enfermedad (TME) alternativos (aparte de acetato de glatiramer o interferón beta).
    2.Haber recibido IFNb-1a SC en los estudios CAMMS323 o CAMMS324, haber completado el periodo de 2 años del estudio y NO haber recibido posteriormente TME alternativos (aparte de acetato de glatiramer o u otro interferón beta).
    3.Haber participado en el estudio CAMMS223
    E.4Principal exclusion criteria
    Cualquier paciente que haya recibido alemtuzumab para indicaciones no autorizadas (es decir, fuera de uno de los estudios previos de Genzyme) será excluido de este estudio. Además, los pacientes tratados con alemtuzumab deben someterse a un examen para detectar posibles problemas de seguridad descalificantes (como se describe en el texto de este protocolo, Sección 9.2.3) antes de volver a recibir el tratamiento.
    Criterios de exclusión para los pacientes tratados con IFNb-1a SC de los estudios CAMMS223, CAMMS323 y CAMMS324
    Los pacientes que recibieron IFNb-1a SC en los estudios previos no serán elegibles para entrar en el estudio de extensión y recibir alemtuzumab si cumplen alguno de los siguientes criterios de exclusión:
    1. No desea recibir alemtuzumab.
    2. Participación en curso en algún otro estudio de investigación.
    3. Haber recibido alemtuzumab para una indicación no autorizada (es decir, fuera de uno de los estudios previos de Genzyme).
    4. Trastorno hemorrágico conocido (por ejemplo, disfibrinogenemia, deficiencia del factor IX, hemofilia, enfermedad de Von Willebrand, coagulación intravascular diseminada [CID], deficiencia de fibrinógeno u otra deficiencia de factores de coagulación) o anticoagulación terapéutica.
    5. Diagnóstico de púrpura trombocitopénica inmune (PTI) u otra anomalía hematológica autoinmune. Los pacientes a los que se les haya diagnosticado PTI según la definición del protocolo en uno de los estudios previos, pueden seguir siendo considerados para el estudio de extensión si la PTI no se consideró autoinmune. Dichas situaciones requieren la previa autorización de Genzyme.
    6. Antecedentes de neoplasia maligna, a excepción del carcinoma cutáneo basocelular.
    7. Intolerancia a terapia de pulso con corticoesteroides, especialmente antecedentes de psicosis inducida por esteroides.
    8. Enfermedad autoinmune significativa, incluyendo, aunque no exclusivamente: citopenias inmunes, artritis reumatoide, lupus eritematoso sistémico, otros trastornos del tejido conjuntivo, vasculitis, enfermedad inflamatoria intestinal, psoriasis grave o enfermedad anti-membrana basal glomerular (enfermedad anti-MBG, también conocida como síndrome de Goodpasture).
    9. Trastorno psiquiátrico grave o crisis epilépticas que no estén adecuadamente controlados con el tratamiento.
    10. Infección por el virus de la hepatitis B o C, seropositivo para el virus de la inmunodeficiencia humana (VIH). Solo aplicable a los pacientes del estudio CAMMS223.
    11. Antecedentes de infecciones micóticas invasivas.
    No estar dispuesto a aceptar el uso de un método anticonceptivo fiable y aceptable a lo largo del periodo de estudio (sólo en el caso de pacientes fértiles). Entre los métodos anticonceptivos fiables y eficaces se incluyen: dispositivo intrauterino (DIU), anticonceptivos hormonales, esterilización quirúrgica, abstinencia o anticonceptivos de doble barrera (condón y capuchón oclusivo [diafragma o capuchón cervical con espermicida]).
    E.5 End points
    E.5.1Primary end point(s)
    Los efectos a largo plazo de alemtuzumab en pacientes que recibieron dicho fármaco antes del estudio de extensión (p. ej., en los estudios CAMMS223, CAMMS323 o CAMMS324) se examinarán:
    -Resumiendo los criterios de valoración de la eficacia, que incluyen la progresión sostenida de la discapacidad (PSD), la tasa de recaída, la mejora sostenida de la discapacidad (MSD) y la variación en la EDSS, RM y CdV, desde la fase inical del estudio previo hasta el mes 36 de la extensión.
    -Resumiendo el porcentaje de pacientes que cumplen los criterios para repetir el tratamiento según las necesidades (RM frente a recaída) y el tiempo hasta que se cumplen los criterios para repetir el tratamiento.

    La eficacia de alemtuzumab en pacientes que recibieron IFNb-1a SC antes del estudio de extensión se evaluará mediante comparaciones antes y después del tratamiento con alemtuzumab sobre los criterios de eficacia señalados anteriormente.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Otras objetivos exploratorios secundarios y terciarios
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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 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
    Para cada paciente el estudio concluirá 26 meses( 3 años) después de su inclusión en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 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 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 455
    F.4.2.2In the whole clinical trial 1500
    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)
    Una vez el estudio de extension finalice, los pacientes seran tratados de acuerdo con el "tratamiento estandar". Cualquier seguimiento de seguridad adicional en relacion a este estudio ocurriara via un mecanismo diferente
    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 Decision2010-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-16
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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
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