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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2009-016508-21
    Sponsor's Protocol Code Number:ORDI-02
    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:2009-12-04
    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 number2009-016508-21
    A.3Full title of the trial
    ESTUDIO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE LA LENALIDOMIDA EN EL TRATAMIENTO DEL LUPUS ERITEMATOSO CUTÁNEO.
    A.4.1Sponsor's protocol code numberORDI-02
    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 SponsorHospital Universitario Vall D'Hebron. Departamento de Medicina Interna
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 REVLIMID 5 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    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 Capsule*
    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 INNLENALIDOMIDA
    D.3.9.3Other descriptive nameLENALIDOMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Lupus Eritematoso Cutáneo
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level HLT
    E.1.2Classification code 10025135
    E.1.2Term Lupus erythematosus (incl subtypes)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia y seguridad del tratamiento con lenalidomida en pacientes con lupus eritematoso cutáneo. La eficacia se evaluará mediante la tasa de pacientes que consigan una remisión completa evaluada por el índice de actividad y severidad del CLASI a la semana 12 de tratamiento. Remisión Completa quedará definida como la resolución completa de la lesión o la presencia de un CLASI 0 a la semana 12 de tratamiento. Remisión parcial se definirá como una mejora en el 50% en la escala del CLASI después del tratamiento.
    E.2.2Secondary objectives of the trial
    •Evaluar la seguridad de tratamiento
    •Evaluar la frecuencia de brotes después de la retirada del fármaco o de su disminución
    •Evaluar el tiempo desde remisión a rebrote de la enfermedad
    •Evaluar la eficacia de un segundo tratamiento con el fármaco o respuesta del brote.
    •Evaluar el impacto en los parámetros inmunológicos como los títulos de anticuerpos anti-DNA y los niveles de complemento.
    •Evaluar el efecto de la Lenalidomida en las citoquinas séricas de pacientes con LEC
    •Evaluar las secuelas residuales (CLASI, variante daño) (28).
    •Evaluar el efecto de la Lenalidomida en la enfermedad sistémica del Lupus.
    •Evaluar la tolerabilidad y desarrollo de efectos secundarios por parte de ambos fármacos.
    •Evaluar posibles biomarcadores de respuesta séricos o tisulares
    •Estudio del mecanismo de acción de la Lenalidomida en el Lupus Cutáneo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Este estudio está destinado a evaluar los posibles mecanismos etiopatogénicos que participan en el desarrollo de lupus cutáneo así como estudiar el mecanismo por el cual actúa la lenalidomida en estos pacientes a nivel cutáneo, tanto en la inmunidad celular como en la apoptosis
    Objetivos:
    Determinación de niveles de citoquinas séricas.
    Estudios histológicos e inmunohistoqíimicos en piel pre y post tratamiento
    Detección de apoptosis por tinción TUNEL
    Niveles de expresión de mRNA tisular
    E.3Principal inclusion criteria
    1.- Edad &#8805;18 años (18 – 65).
    2.- Lupus Eritematoso Cutáneo crónico (Discoide o Tumidus) o Lupus Eritematoso Subagudo demostrado por biopsia, con o sin evidencia de afectación sistémica por la enfermedad.
    3.- Presencia de al menos un grado II de eritema definido por la escala de severidad de la afectación cutánea (CLASI – Cutaneous lupus Activity and Severity Index) (ANEXO I)
    4.- Aquellos pacientes tratados con talidomida que presenten efectos secundarios que no permitan su continuación o presenten falta de eficacia y tengan evidencia de lesiones activas.
    5.- Pacientes con Lupus Eritematoso Cutáneo que han fallado al tratamiento convencional de por lo menos 3 meses con antimaláricos (plaquenil/cloroquina) a dosis adecuadas y corticoides tópicos.
    6- Pacientes que presenten un Lupus Eritematoso Cutáneo con una afectación del más del 18% de la superficie corporal (calculado según la regla de los nueve para calcular la superficie corporal) (ANEXO II)
    7.- Obtención del consentimiento informado.
    8.- Capacidad de adherirse al esquema de visitas del estudio y a los requerimientos del estudio.
    9.- Mujeres no embarazas y que no planeen quedarse embarazadas durante el estudio.
    10.- Mujeres en edad fértil deben tener un test de embarazo sérico o urinario en el día de la inclusión y deben comprometerse a utilizar métodos anticonceptivos eficaces durante el estudio. Los pacientes hombres deberán también comprometerse a medidas contraceptivas y a varios test de embarazo durante el estudio.
    Los varones deben comprometerse a utilizar métodos de barrera incluso si han tenido una vasectomía durante el estudio.
    E.4Principal exclusion criteria
    1.- Falta de consentimiento informado.
    2.- Embarazo o lactancia o aquellos pacientes que planeen una gestación durante el estudio.
    3.- Historia conocida de hipersensibilidad a la Talidomida
    4.- Brote de enfermedad sistémica severa asociada que precise por criterio del médico responsable de otros tratamientos inmunosupresores
    5.-Patología psiquiátrica o social concomitante que dificulte la colaboración y el seguimiento del paciente y que le impidiera entender el consentimiento informado.
    6.-Evidencia de una alteración analítica, en los 30 días antes de la inclusión en el estudio
    . Plaquetas <30x10E9 cells/L
    . Leucocitos <1500x106 /L

    7- Evidencia de enfermedad renal actual (FGR<50 mL/min) o síntomas de enfermedad renal progresiva o poco controlada
    8.- Cualquier otra condición médica relevante, incluyendo alteraciones analiticas, que pudiera poner al paciente en situación de riesgo pudiera dificultar la capacidad de interpretar los datos del estudio.
    9.- Historia de previos episodios trombóticos (TVP o PE)
    10.- Presencia de anticuerpos antifosfolípido (anticardiolipina o anticoagulante lúpico) por su efecto protrombótico.
    11.- Infeccion por HIV o virus de la hepatitis B o C
    E.5 End points
    E.5.1Primary end point(s)
    Evaluar la eficacia y seguridad del tratamiento con lenalidomida en pacientes con lupus eritematoso cutáneo.
    Remisión Completa quedará definida como la resolución completa de la lesión o la presencia de un CLASI 0 a la semana 12 de tratamiento. Remisión parcial se definirá como una mejora en el 50% en la escala del CLASI después del tratamiento.
    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
    Estudio de mecanismos de acción del fármaco
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned 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
    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 Decision2010-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-31
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 22:43:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA