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    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).

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    Summary
    EudraCT Number:2011-005667-25
    Sponsor's Protocol Code Number:HGS1006-C1113
    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:2012-12-21
    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 number2011-005667-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled 52-Week Study
    to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
    Estudio Aleatorizado, Doble Ciego, Controlado Por Placebo, De 52 Semanas De Duración Para Evaluar Los Acontecimientos Adversos De Especial Interés En Adultos Con Lupus Eritematoso Sistémico activo, Con Autoanticuerpos Positivos, Que Toman Belimumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Belimumab Assessment of Safety in SLE (BASE)
    Evaluación de la Seguridad del Belimumab en LES (BASE)
    A.4.1Sponsor's protocol code numberHGS1006-C1113
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01705977
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHuman Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
    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 supportHuman Genome Sciences Inc
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044208 990 4466
    B.5.5Fax number0044208 990 4466
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 Benlysta 400 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd, Greenford, Middlesex UB6 0NN, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBelimumab
    D.3.2Product code L04AA26
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBELIMUMAB
    D.3.9.1CAS number 356547-88-1
    D.3.9.3Other descriptive nameBenlysta
    D.3.9.4EV Substance CodeSUB25607
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 placeboPowder for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus Erythematosus
    Lupus Eritematoso
    E.1.1.1Medical condition in easily understood language
    Lupus Erythematosus
    Lupus Eritematoso
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the following in adult SLE subjects receiving belimumab plus standard therapy versus subjects receiving placebo plus standard therapy:
    - Mortality and adverse events of special interest over 1 year (through 52 weeks).
    - Corticosteroid reduction during Weeks 40-52.
    Los objetivos de este estudio son evaluar los aspectos siguientes, en sujetos adultos con LES tratados con belimumab más tratamiento convencional frente a los tratados con placebo más tratamiento convencional:
    ? Mortalidad y acontecimientos adversos de interés especial durante 1 año (52 semanas).
    ? Reducción de corticosteroides durante las semanas 40-52.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    English Title: Pharmacogenetic Research
    Date: 08 March 2012
    Objectives:
    -Relationship between genetic variants and the pharmacokinetics of belimumab.
    -Relationship between genetic variants and safety and/or tolerability of belimumab.
    -Relationship between genetic variants and efficacy of belimumab.
    Título en español: Investigación Farmacogenética
    Fecha: Marzo 8 de 2012
    - Relación entre las variantes genéticas y la farmacocinética del belimumab.
    - Relación entre las variantes genéticas y la seguridad y/o la tolerabilidad del belimumab.
    - Relación entre las variantes genéticas y la eficacia del belimumab.
    E.3Principal inclusion criteria
    - Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
    - Active SLE disease.
    - Autoantibody-positive.
    - On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).
    -Tener un diagnóstico de LES, según los criterios del Colegio de Reumatología (ACR) .
    - Enfermedad de LES activa
    - Positividad para autoanticuerpos
    - Estar recibiendo un tratamiento estable para el LES consistente en corticosteroides (por ejemplo prednisona), Antipalúdicos (por ejemplo hidroxicloroquina) y/o inmunosupresores (como por ejemplo azatioprina, metotrexato, micofenolato)
    E.4Principal exclusion criteria
    - Pregnant or nursing.
    - Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
    - Have received a live vaccine within the past 30 days.
    - Have severe active lupus kidney disease.
    - Have severe active central nervous system (CNS) lupus.
    - Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
    - Estar en embarazo o en periodo de lactancia
    - Haber recibido tratamiento con cualquiera de los siguientes medicamentos: belimumab como producto comercializado o como producto en investigación; fármacos dirigidos contra los linfocitos B (p. ej., rituximab) en el año inmediatamente anterior; Cualquier fármaco biológico (p. ej., adalimumab, etanercept, infliximab, anakinra) en los 90 días anteriore
    - Haber recibido una vacuna de organismos vivos en los 30 días anteriores
    - Tener nefropatía lúpica grave
    - Tener lupus del sistema nervioso central (SNC) activo grave
    - Tener antecedentes o presencia actual de infección por Virus de Inmunodeficiencia Humana, de la hepatitis B o C.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    1) Incidence of all-cause mortality
    2) Incidence of adverse events of special interest. Summary of the number and percentage of participants with adverse events within 8 prespecified categories: serious infections, non-serious opportunistic infections and other infections of interest, malignancies (excluding non-melanoma skin cancers), non-melanoma skin cancers, psychiatric events, suicidality, serious infusion and hypersensitivity reactions, and all serious adverse events.
    Criterios de Valoración primarios:
    1) La incidencia de todas las causas de mortalidad
    2) La incidencia de acontecimientos adversos de especial interés. Resumen del número y porcentaje de participantes con acontecimientos adversos en 8 categorías preestablecidas: infecciones graves, infecciones oportunistas no graves y otras infecciones de interés, los tumores malignos (excluyendo a los cáncer de piel no-melanoma ), cáncer de piel no-melanoma , eventos psiquiátricos, tendencias suicidas , reacciones a la infusión y de hipersensibilidad graves, y todos los acontecimientos adversos graves.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints
    1) Incidence of all-cause mortality -Up to 52 weeks
    2) Incidence of adverse events of special interest -Up to 52 weeks
    Criterios de Valoracion en tiempo
    1) La incidencia de todas las causas de mortalidad- hasta 52 semanas
    2) La incidencia de acontecimientos adversos de especial interés- hasta 52 semanas
    E.5.2Secondary end point(s)
    Reduction in prednisone dose.
    Percent of participants whose average prednisone dose has been reduced by ? 25% from baseline to ? 7.5 mg/day during Weeks 40 through 52 in participants receiving greater than 7.5 mg/day at baseline.
    Reducción de la dosis de Prednisona
    Porcentaje de participante que en promedio han disminuido un 25% desde el inicio hasta 7.5mg/día durante las semanas 40 hasta la 52 en participantes reciviendo un máximo de 7.5 mg/día al inicio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint: Baseline, weeks 40 to 52.
    Criterio de valoracion en tiempo: desde el inicio, de la semana 40 hasta la 52
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    Estonia
    Hong Kong
    Hungary
    India
    Indonesia
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Malaysia
    Mexico
    New Zealand
    Norway
    Peru
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    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
    Last subject's 5 year follow up assessment
    Ultimo sujeto que complete la valoración del seguimiento de los 5 años
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state132
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 670
    F.4.2.2In the whole clinical trial 5000
    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)
    After the completion of the Week 52 assessments, subjects who wish to continue treatment may be able to do so by being prescribed commercially available belimumab. If belimumab is not commercially available in a subject?s country of participation, the subject may be able to receive belimumab under a separate continuation protocol.
    Después de completar las valoraciones de la semana 52, los sujetos que deseen continuar el tratamiento pueden estar en condiciones de hacerlo bajo prescripcion, el belimumab esta disponible comercialmente. Si el belimumab no está disponible comercialmente en el país del sujeto, el sujeto pueden estar en condicione de recibir belimumab bajo un protocolo de continuación separado.
    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 Decision2013-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-30
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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
    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.

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