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    Summary
    EudraCT Number:2014-000092-62
    Sponsor's Protocol Code Number:LPS13650
    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:2014-07-04
    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 number2014-000092-62
    A.3Full title of the trial
    Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada.
    Estudio de un solo grupo para evaluar las guías detalladas de infusión para el
    manejo de las reacciones asociadas a la infusión (RAI) en pacientes con
    esclerosis múltiple remitente-recurrente (EMRR) tratados con LEMTRADA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Management of the infusion-associated reactions in RRMS patients treated with Lemtrada
    Manejo de las reacciones asociadas a la infusión (RAI) en pacientes tratados con LEMTRADA.
    A.3.2Name or abbreviated title of the trial where available
    EMERALD
    EMERALD
    A.4.1Sponsor's protocol code numberLPS13650
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1153-3922
    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 SponsorGenzyme Corporation
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.5Fax numberNA
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 Lemtrada
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Therapeutics Ltd.
    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 nameLemtrada
    D.3.2Product code GZ402673
    D.3.4Pharmaceutical form 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 INNalemtuzumab
    D.3.9.1CAS number 216503-57-0
    D.3.9.2Current sponsor codeGZ402673
    D.3.9.4EV Substance CodeSUB12459MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanised Monoclonal Antibody
    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
    Relapsing-remitting multiple sclerosis
    Esclerosis múltiple remitente-recurrente
    E.1.1.1Medical condition in easily understood language
    Relapsing-remitting multiple sclerosis
    Esclerosis múltiple remitente-recurrente
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the distribution of IARs by severity grade when Lemtrada is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions
    Evaluar la distribución de las RAI por grado de gravedad al administrar
    LEMTRADA a pacientes con EMRR medicados según un algoritmo
    especificado diseñado para manejar las reacciones asociadas a la infusión
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label
    - Signed written informed consent
    Criterios de inclusión:
    · Pacientes adultos con EMRR que inicien el tratamiento con LEMTRADA de acuerdo con la ficha técnica local aprobada
    · Formulario de consentimiento informado (FCI) firmado
    E.4Principal exclusion criteria
    - Previously treated with Lemtrada
    - Contraindications to Lemtrada according to the labeling in the country
    - Any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label
    - Currently participating in another investigational interventional study
    - Any technical/administrative reason that makes it impossible to enroll the patient in the study
    - Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
    - Patient who has withdrawn consent before enrollment (starting from signed informed consent form)
    - Despite screening of the patient, enrolment is stopped at the study level
    - Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy
    - Pregnancy (defined as positive beta-HumanChorionicGonadotropin blood test), breast feeding
    - Known infection with latent tuberculosis or active Tuberculosis
    - Known infection with Hepatitis B, Hepatitis C
    Principales criterios de exclusión
    · Contraindicaciones a la administración de LEMTRADA de acuerdo
    con la ficha técnica del país
    · Cualquier contraindicación conocida al tratamiento sintomático
    utilizado en las directrices sobre el manejo de las infusiones en
    función de su ficha técnica local aprobada
    · Pacientes tratados previamente con LEMTRADA
    · Pacientes que estén participando actualmente en otro estudio de
    intervención en fase de investigación
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC).
    An IAR is any adverse event occuring during or within 24 hours of Lemtrada infusion.

    Proportion of IARs

    Proportion and type of serious IARs

    Proportion by type (as defined by clinical symptoms)
    El objetivo principal se evaluará resumiendo:
    · El número (%) de RAI
    · El número (%) y el tipo de RAI graves
    · El número (%) por tipo (según los síntomas clínicos)
    Todos los resúmenes mostrarán el total general y las estadísticas desglosadas por momento y ciclo de infusión o por gravedad, si procede.
    Esto incluirá resúmenes del número (%) de RAI desglosado por intervalos de 2 horas desde el inicio de la infusión hasta 2 horas después del final de esta.
    Una RAI se define como cualquier acontecimiento adverso que aparece
    durante la infusión de LEMTRADA o en un plazo máximo de 24 horas tras la infusión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after each of the two treatment courses
    30 días después de cada uno de los ciclos de tratamiento
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 No
    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
    Guidance for the management of the infusion-associated reactions (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada
    Guía para el manejo de las reacciones asociadas a la infusión (RAI) en pacientes con esclerosis múltiple remitente-recurrente (EMRR) tratados con LEMTRADA.
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    France
    Netherlands
    Spain
    Switzerland
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    Última Visita del Último Paciente
    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 months7
    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 months7
    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: 56
    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
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 56
    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 end of the second course of Lemtrada treatment, patients will be followed by their physician in a regular healthcare setting until 48 months safety monitoring period is completed as required per Lemtrada local label.
    Después del final del segundo ciclo del tratamiento con Lemtrada, los pacientes serán seguidos por sus médicos en sus centros de salud habituales, hasta que se complete período de seguimiento de seguridad de 48 meses, tal y como se especifica en la ficha local de Lemtrada.
    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 Decision2014-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-01
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