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    Summary
    EudraCT Number:2005-000343-28
    Sponsor's Protocol Code Number:WX18411
    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:2006-02-02
    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 number2005-000343-28
    A.3Full title of the trial
    Continuación opcional del tratamiento doblemente enmascarado para los pacientes que hayan conseguido un buen control de los síntomas con la administración estable de prednisona y que hayan completado el Protocolo WX17798 (ver resto de título en protocolo)
    A.4.1Sponsor's protocol code numberWX18411
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 CellCept 500mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.1Product nameCellCept 500 mg tablets
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmycophenolate mofetil
    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) 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 typeallopathic medicinal product: immunosuppressive agent
    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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Miastenia grave
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10028417
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Abordar las preocupaciones del investigador relativas al tratamiento posterior al estudio de los pacientes que hayan mejorado con el tratamiento doblemente enmascarado del Protocolo WX17798 dando la opción de continuar dicho tratamiento con doble enmascaramiento hasta que pueda desenmascararse la asignación del tratamiento tras el cierre de la base de datos
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia y la tolerancia del tratamiento con MMF en comparación con placebo en pacientes con MG que estén recibiendo prednisona
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Pacientes que:
    1. Proporcionen su consentimiento informado por escrito para este estudio de continuación de tratamiento doblemente enmascarado opcional.
    2. Hayan completado 36 semanas de tratamiento con MMF o placebo doblemente enmascarados en el Protocolo WX17798
    3. Hayan conseguido un buen control de los síntomas con una dosis estable de prednisona. El buen control de los síntomas se define como Manifestaciones mínimas o remisión farmacológica (Definiciones modificadas del estado postintervencional de la MGFA) desde la Semana 32 hasta la finalización del estudio en la Semana 36 del Protocolo WX17798. La dosis estable de prednisona se define como la ausencia de necesidad de cambiar la dosis de prednisona después de la Semana 32.
    E.4Principal exclusion criteria
    1. Embarazo, lactancia o lactación o uso de métodos anticonceptivos no fiables
    2. Recepción o necesidad de recepción regular programada de plasmaféresis o tratamiento intravenoso con inmunoglobulinas (IVIG)
    3. Participación en otro ensayo clínico o utilización de fármacos experimentales durante la continuación con doble enmascaramiento
    4. Uso de otros tratamientos prohibidos
    5. Enfermedad, acontecimiento adverso o intolerancia al tratamiento doblemente enmascarado que pudiera impedir la continuación, entre ellas:
     timoma
     enfermedad gastrointestinal activa grave, diarrea grave persistente, hemorragia gastrointestinal
     úlcera péptica no cicatrizada activa
     inmunodeficiencia congénita o adquirida
     consumo excesivo, clínicamente significativo, de drogas o alcohol
     neoplasia maligna o enfermedad linfoproliferativa
     infección bacteriana grave (que precise antibioterapia IV), infección vírica grave (por ejemplo, enfermedad vírica invasora de órgano, como el H. simplex, el H. zoster y el citomegalovirus ciclomegalovirus) o enfermedad fúngica invasora durante el protocolo WX17798
     tiroidopatía no controlada
     enfermedad cardiovascular grave
     hipertensión persistente no controlada
     diabetes mellitus no controlada
     disfunción renal o hepática significativa [creatinina sérica ≥ 200 µmol/L; aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) o bilirrubina mayor de 2,5 veces el límite superior de lo normal
     insuficiencia pulmonar que precise complemento de oxígeno
     insuficiencia de la médula ósea; hemoglobina <9 g/dL; leucopenia [recuento de leucocitos <3000/mm3; recuento absoluto de neutrófilos (ANC) <1,5/µL]; trombocitopenia (recuento de plaquetas) <100.000/mm3
    6. Otra enfermedad que, a juicio del investigador, pueda estar asociada a un mayor riesgo para el paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Se compararán los grupos de tratamiento para medir la proporción de pacientes que alcanzan un estado de respondedor. Se considerará que un paciente es respondedor/a si cumple todos los criterios siguientes:

    1) Manifestaciones Mínimas o Remisión Farmacológica (definiciones modificadas del estado postintervencional de la MGFA) desde la Semana 32 hasta la terminación del estudio, en la Semana 36 Y
    2) Dosis de prednisona no superior a 7,5 mg/día desde la Semana 32 hasta la terminación del estudio, en la Semana 36 Y
    3) Dosis de inhibidor de la colinesterasa de  120 mg/día desde la Semana 33* hasta la terminación del estudio, en la Semana 36

    * los pacientes tienen una semana para reducir la dosis del inhibidor de la colinesterasa después de alcanzar los 7,5 mg/día de prednisona
    Safety assessments:
    - Clinical laboratory tests (hematology, serum chemistry, urinalysis)
    -Monitoring of Adverse events (AEs)
    - Physical examination , including clinical examination for tumors
    - Vital signs (blood pressure and heart rate)
    - Electrocardiograms (standard 12-lead tracing)
    - Record of all concomitant medications
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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
    Ver protocolo
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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) Yes
    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 2006-02-02. 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 136
    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)
    See the 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 Decision2006-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-11-01
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