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    Summary
    EudraCT Number:2009-016095-68
    Sponsor's Protocol Code Number:M10-877
    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:2010-06-04
    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 number2009-016095-68
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo diseñado para demostrar la eficacia y la seguridad del adalimumab como tratamiento de mantenimiento en sujetos adultos que precisan corticosteroides en dosis altas por uveítis intermedia, uveítis posterior o
    panuveítis no infecciosa activa.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberM10-877
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 HUMIRA 40 mg solución inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES 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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.3Other descriptive nameADALIMUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uveítis intermedia, uveítis posterior o panuveítis no infecciosa activa

    Active Non-infectious Intermediate-, Posterior-, or Pan-uveitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10022557
    E.1.2Term Intermediate uveitis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10033687
    E.1.2Term Panuveitis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo de este estudio es evaluar la eficacia y la seguridad de una dosis inicial de 80 mg de
    adalimumab seguida de una dosis de 40 mg administrada cada dos semanas por vía subcutánea
    (s.c.) a partir de la semana 1 en comparación con un placebo como tratamiento de mantenimiento en sujetos que precisan corticosteroides en dosis altas por uveítis intermedia, uveítis posterior o panuveítis no infecciosa activa.
    E.2.2Secondary objectives of the trial
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • El sujeto tiene una edad &#8805; 18 años.
    • El sujeto ha recibido un diagnóstico de uveítis intermedia, uveítis posterior o panuveítis no infecciosa.
    • El sujeto debe padecer enfermedad activa en la visita basal, definida como la presencia de al menos
    uno de los siguientes parámetros en un ojo como mínimo a pesar de haber recibido al menos dos
    semanas de tratamiento con prednisona en dosis &#8805; 10 mg/día (o un corticosteroide oral equivalente):
    o lesión vascular retiniana inflamatoria y/o coriorretiniana inflamatoria activa
    o grado de células en la cámara anterior &#8805; 2+ (criterios del grupo de trabajo SUN
    [Standardization of Uveitis Nomenclature, normalización de la nomenclatura de la uveítis)
    o grado de opacidad del vítreo &#8805; 2+ (criterios del NEI [National Eye Institute]/SUN)
    • El sujeto ha estado recibiendo prednisona en dosis &#8805; 10 mg/día (o un corticosteroide equivalente)
    durante al menos 2 semanas antes de la selección y se mantiene con la misma dosis desde la selección
    hasta la visita basal.
    E.4Principal exclusion criteria
    • Sujetos con uveítis anterior aislada.
    • Sujetos con respuesta previa insuficiente o intolerancia a corticosteroides en dosis altas (equivalente de 1 mg/kg diario o 60 a 80 mg/día de prednisona).
    • Sujetos con uveítis infecciosa confirmada o sospechada, por ejemplo, uveítis infecciosa debida a
    tuberculosis, infección por citomegalovirus, enfermedad de Lyme, toxoplasmosis e infección por el VHS (virus del herpes simple).
    • Sujetos con coroidopatía serpiginosa.
    • Sujetos con opacidad corneal o del cristalino que impida la visualización del fondo del ojo o que
    probablemente requiera cirugía de cataratas durante el estudio.
    • Sujetos con una presión intraocular &#8805; 25 mm Hg y que estén recibiendo &#8805; 2 medicamentos para el
    glaucoma o que presenten signos de lesión glaucomatosa del nervio óptico.
    • Sujetos que tengan una mejor agudeza visual corregida (MAVC) inferior a 20/200 (logMAR de
    ETDRS > 1,0) en un ojo como mínimo.
    • Sujetos con uveítis intermedia y síntomas o hallazgos en la IRM indicativos de una enfermedad
    desmielinizante como la esclerosis múltiple. Todos los sujetos con uveítis intermedia deberán haberse
    realizado una RM cerebral previa en el momento del diagnóstico de la uveítis intermedia o con
    posterioridad.
    • Sujetos que han recibido previamente tratamiento anti-TNF y con cualquier producto biológico con una
    posible repercusión terapéutica sobre la uveítis no infecciosa.
    • Sujetos que hayan recibido un implante de glucocorticosteroides (Retisert®).
    • Sujetos que hayan recibido corticosteroides intraoculares o perioculares en los 90 días previos a la visita basal.
    • Sujetos con retinopatía diabética no proliferativa intensa o proliferativa.
    • Sujetos con anomalías de la interfaz vitreorretiniana (p. ej., tracción vitreomacular, membranas epirretinianas, etc.) que puedan causar lesión estructural macular independiente del proceso
    inflamatorio.
    • Sujetos con una opacidad del vítreo grave que impida la visualización del fondo del ojo en la visita de Selección.
    E.5 End points
    E.5.1Primary end point(s)
    El tiempo hasta el fracaso del tratamiento. Por favor, remitánse a la seccion 5.3.3.1 del protocolo del estudio para más información.
    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 Yes
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    The end-of-study is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is later (refer section 13 of the protocol)
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 250
    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 Decision2010-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
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