Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-012072-28
    Sponsor's Protocol Code Number:MO22468
    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:2009-10-01
    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 number2009-012072-28
    A.3Full title of the trial
    Estudio randomizado en fase IIIb de MabThera® (rituximab) agregado a quimioterápia, bendamustina o clorambucilo, en pacientes con leucemia linfática crónica.

    A randomized Phase IIIb study of MabThera ® (rituximab) added to a chemotherapy, bendamustine or chlorambucil, in patients with Chronic Lymphocytic Leukemia.
    A.3.2Name or abbreviated title of the trial where available
    RiBECCA
    A.4.1Sponsor's protocol code numberMO22468
    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 Yes
    D.2.1.1.1Trade name MABTHERA 100 mg concentrado para solución para perfusión
    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.3.4Pharmaceutical 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameRITUXIMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 recombinante.
    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 LEUKERAN 2 mg
    D.2.1.1.2Name of the Marketing Authorisation holderWELLCOME FARMACEUTICA, S.A.
    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 Film-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 INNCLORAMBUCILO
    D.3.9.1CAS number 305-03-3
    D.3.9.3Other descriptive nameCHLORAMBUCIL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 No
    D.IMP: 3
    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 Ribomustin®
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Powder 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 INNbendamustine hydrochloride
    D.3.9.1CAS number 16506-27-2
    D.3.9.2Current sponsor codeRO5469113
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 No
    D.IMP: 4
    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 MABTHERA 500 mg concentrado para solución para perfusión
    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.3.4Pharmaceutical 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameRITUXIMAB
    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 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 recombinante.
    D.IMP: 5
    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 Ribomustin®
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Powder 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 INNbendamustine hydrochloride
    D.3.9.1CAS number 16506-27-2
    D.3.9.2Current sponsor codeRO5469113
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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 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
    Pacientes con leucemia linfática crónica (LLC) en primera linea o segunda línea (máximo de una línea de tratamiento previa) con necesidad de tratamiento. (En España, solo se incluirán pacientes en segunda línea).

    First line or second line (maximum of 1 line of previous treatment) patients with chronic lymphocytic leukemia (CLL) with need for treatment.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la tasa de respuesta completa (RC) confirmada después de 6 ciclos de tratamiento entre los dos brazos de tratamiento, en los pacientes con LLC en primera y en segunda línea combinados. En España, solo se incluirán pacientes en segunda línea.
    E.2.2Secondary objectives of the trial
    Confirmar aun más la efectividad de la adición de rituximab a bendamustina o clorambucilo en cuanto a las categorías de respuesta tumoral (tasa de respuesta global [TRG], respuesta completa [RC], RC con recuperación incompleta de la médula ósea (RCi), respuesta parcial [RP], respuesta parcial nodular [RPn], enfermedad estable [EE] o progresión de la enfermedad [PE]), supervivencia libre de progresión (SLP), supervivencia libre de enfermedad (SLE), supervivencia libre de eventos (SLEv), tiempo hasta el siguiente tratamiento de la leucemia (TSTL), duración de la respuesta, supervivencia global (SG), respuesta molecular y enfermedad mínima residual (EMR).
    Evaluar la seguridad en cuanto a acontecimientos adversos (AA), acontecimientos adversos graves (AAG), análisis de laboratorio (hematología habitual, inmunoglobulinas y bioquímica clínica), peso, constantes vitales y exploración física.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito, firmado y fechado.
    2. 18 años o más de edad
    3. Fenotipo de las células tumorales compatible con LLC: CD5+ CD20+ CD23+.
    4. LLC activa en estadio B o C de Binet progresivo y con necesidad de tratamiento según los criterios del NCI de 2008 [Apéndice 5 del protocolo] (nota: sólo es necesario cumplir uno de los criterios anteriores).
    5. Estado funcional del Eastern Cooperative Oncology Group (ECOG) &#8804; 2 (véase el Apéndice 4 del protocolo).
    6. No apto para recibir tratamiento con fludarabina. Los motivos pueden ser:
    a) Procesos médicos concurrentes, como antecedentes de infecciones oportunistas o infecciones de grado 3 ó 4 reiteradas de otros tipos.
    b) Pacientes con deterioro grave de la función de la MO (trombocitopenia, anemia o granulocitopenia), por motivos distintos a la enfermedad subyacente (LLC).
    c) Inmunodeficiencia.
    d) Ancianos (&#8805; 75 años), ya que hay datos limitados sobre el uso de fludarabina en esta población.
    e) Antecedentes de procesos autoinmunitarios o resultado positivo en la prueba de Coombs.
    f) Procesos autoinmunitarios (p. ej., anemia hemolítica autoinmune, trombocitopenia autoinmune, púrpura trombocitopénica, pénfigo o síndrome de Evans).
    g) A criterio del médico a cargo del tratamiento.
    7. Solo se permitirá el tratamiento previo con rituximab o clorambucilo.
    8. Las mujeres en que no hayan transcurridos 2 años desde el inicio de la menopausia y que no estén esterilizadas quirúrgicamente deberán contar con una prueba de embarazo en suero negativa en la semana anterior al primer ciclo de tratamiento.
    E.4Principal exclusion criteria
    1. Pacientes que hayan recibido tratamiento previo con rituximab o clorambucilo y que hayan recaído menos de 12 meses después de la primera dosis del tratamiento de primera línea.
    2. Trasplante autólogo de células stem previo o previsto durante el estudio.
    3. Trasplante alogénico de células stem previo o previsto durante el estudio.
    4. Radioinmunoterapia en los 6 meses anteriores al inicio del tratamiento.
    5. Cualquier otro tratamiento antineoplásico concurrente (p. ej., alquilantes, antimetabolitos, análogos de purina o anticuerpos monoclonales) o glucocorticoides a menos que se administren en dosis equivalentes a &#8804; 20 mg de prednisolona/día. Se permite el uso de esteroides inhalados o tópicos.
    6. Pacientes previamente tratados con ofatumumab.
    7. Pacientes con transformación a formas tumorales agresivas de células B(p. ej., linfoma de células grandes B, síndrome de Richter o leucemia prolinfocítica de estirpe B [LPL]).
    8. Afectación conocida o sospechada del sistema nervioso central (SNC) por la LLC.
    9. Tumor maligno pasado o actual en los 2 últimos años antes de la selección, excepto:
    a) Carcinoma de cuello uterino em estadio 1B o inferior.
    b) Carcinoma basocelular y espinocelular no infiltrante.
    c) Melanoma maligno con una RC de una duración > 10 años.
    d) Otros diagnósticos de cáncer con una RC de una duración > 5 años.
    10. Cirugía mayor (excepto biopsia ganglionar) en los 28 días anteriores al primer ciclo de tratamiento del estudio.
    11. Enfermedad infecciosa crónica o activa en curso con necesidad de tratamiento sistémico, por ejemplo, osteomielitis.
    12. Antecedentes de enfermedad cerebrovascular importante, por ejemplo, déficit neurológico isquémico reversible prolongado o accidente cerebrovascular (hemorrágico o isquémico).
    13. Pacientes con infección conocida por el virus de la inmunodeficiencia humana (VIH) o con infección activa por el virus de la hepatitis B (VHB) o C (VHC).
    14. Enfermedad subyacente grave que pueda afectar a la capacidad del paciente para participar en el estudio (p. ej., diabetes mellitus no controlada, úlceras gástricas, enfermedad autoinmune activa, hipertensión arterial no controlada o cardiopatía preexistente, enfermedad pulmonar obstructiva crónica grave con hipoxemia o disfunción orgánica importante [hígado, riñón]). Debe aplicarse el criterio del investigador.
    15. Valores analíticos de selección: determinar todos los valores analíticos
    a) Creatinina < 1,5 veces el límite superior de la normalidad [LSN].
    b) Bilirrubina total > 1,5 veces el LSN (a menos que se deba a afectación hepática por la LLC).
    c) Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 2,5 veces el LSN (a menos que se deba a afectación hepática por la LLC).
    d) Fosfatasa alcalina > 2,5 veces el LSN (a menos que se deba a afectación hepática por la LLC).
    16. Función hematológica inadecuada:
    a) Recuento absoluto de neutrófilos (RAN) < 1,0 109/l, a menos que se deba a afectación de la MO por la LLC.
    b) Recuento de plaquetas < 50 109/l, a menos que se deba a afectación de la MO por la LLC.
    c) Hemoglobina < 9,0 g/dl, a menos que se deba a afectación de la MO por la LLC.
    17. Hipersensibilidad conocida o sospechada a los componentes del producto en investigación (en particular, hipersensibilidad o reacción anafiláctica conocida a anticuerpos o proteínas murinas).
    18. Esperanza de vida inferior a 6 meses.
    19. Incapacidad conocida o sospechada del paciente para cumplir el protocolo del estudio.
    20. Embarazo o lactancia.
    21. Pacientes de ambos sexos en edad fértil no dispuestos a utilizar un método anticonceptivo eficaz (anticonceptivos orales, dispositivo intrauterino o método de barrera junto con gel espermicida o esterilización quirúrgica) durante el estudio y un año después de la última dosis de medicación del estudio.
    22. Incapacidad de otorgar el consentimiento informado.
    23. Citopenia autoinmune importante evaluada por el médico (los pacientes con una prueba de Coombs positiva sin signos clínicos de anemia hemolítica autoinmune son aptos para participar en el estudio).
    24. Pacientes que han recibido un tratamiento en investigación en los 30 días anteriores a la selección.
    25. Trastorno médico que requiere el uso crónico de corticosteroides orales.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal es la tasa de RC confirmada (sí/no) después del tratamiento con 6 ciclos de fármaco del estudio (la definición de RC confirmada se facilita en la sección 5.3.2. del protocolo).
    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 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 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 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 Yes
    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.8.3 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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    El final de la parte clínica del estudio es la fecha de la última visita del último paciente (UVUP), que se prevé aproximadamente para el tercer trimestre de 2013. Los pacientes serán objeto de seguimiento hasta la fecha límite de recogida de datos (en torno al tercer trimestre de 2013, o al mes 36, lo que ocurra antes)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 660
    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)
    El seguimiento continuará hasta la fecha de corte (aproximadamente el tercer trimestre de 2013, o el mes 36, lo que ocurra antes).
    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 Decision2009-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-31
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA