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    Summary
    EudraCT Number:2013-005557-73
    Sponsor's Protocol Code Number:I10E-1302
    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:2014-08-27
    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 number2013-005557-73
    A.3Full title of the trial
    An international, multicentre, efficacy and safety study of I10E in
    initial and maintenance treatment of patients with Chronic
    Inflammatory Demyelinating Polyradiculoneuropathy
    Estudio internacional, multicéntrico, sobre la eficacia y la seguridad de I10E en tratamientos iniciales y de mantenimiento de pacientes con polirradiculoneuropatía desmielinizante inflamatoria crónica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study on efficacy and safety of I10E in CIDP patients
    Un estudio Internacional sobre eficacia y seguridad de I10E en pacientes con CIDP.
    A.3.2Name or abbreviated title of the trial where available
    PRISM
    PRISM
    A.4.1Sponsor's protocol code numberI10E-1302
    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 SponsorLFB BIOTECHNOLOGIES
    B.1.3.4CountryFrance
    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 supportLFB BIOTECHNOLOGIES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street Address3, avenue des Tropiques, BP 40305 ? LES ULIS
    B.5.3.2Town/ cityCOURTABOEUF CEDEX
    B.5.3.3Post code91958
    B.5.3.4CountryFrance
    B.5.4Telephone number+33169 82 70 10
    B.5.5Fax number+33169 82 72 72
    B.5.6E-mailneuharte@lfb.fr
    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 No
    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 namehuman normal immunoglobulin for intravenous administration
    D.3.2Product code I10E
    D.3.4Pharmaceutical form 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 INNHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.2Current sponsor codeI10E
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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 Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
    Polirradiculoneuropatía desmielinizante inflamatoria crónica (CIDP)
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired paralytic illness affecting peripheral nerves and caused by a demyelinating process.
    Polirradiculoneuropatía desmielinizante inflamatoria crónica (CIDP) es una enfermedad de parálisis adquirida que afecta a los nervios periféricos y que está causada por un proceso desmielinizante.
    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 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    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
    The primary objective of this study is to assess the efficacy of I10E in improving the disability of patients with CIDP.
    El objetivo principal de este estudio es evaluar la eficacia de I10E en la mejoría de la discapacidad de pacientes con CIDP.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety of I10E in patients with CIDP.
    El objetivo secundario es evaluar la seguridad de I10E en pacientes con CIDP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patient aged 18 years or more.
    2. - Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria.
    - Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out.
    - CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique).
    - Lewis-Sumner syndrome.
    3. Score of at least 2 on the adjusted INCAT disability scale.
    4. Patient who either :
    a) has never been previously treated with Ig (Ig-naive patient)
    Or
    b) was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening.
    5. Covered by national healthcare insurance system as required by local regulations.
    6. Written informed consent obtained prior to any study-related procedures.
    1. Hombre o mujer de 18 años en adelante.
    2. - PDIC probable o confirmada, según los criterios clínicos y neurofisiológicos de las directrices de 2010 de la Federación europea de sociedades neurológicas (European Federation of Neurological Societies, EFNS)/Sociedad del nervio periférico (Peripheral Nerve Society, PNS).
    - PDIC motora pura, siempre y cuando se haya descartado un diagnóstico de neuropatía motora multifocal.
    - PDIC asociada a gammapatía monoclonal de relevancia indeterminada (GMRI), siempre y cuando el título de anticuerpos anti-MAG sea inferior al límite de negatividad de la técnica empleada (1.000 BTU con la técnica de ELISA de Bühlmann).
    - Síndrome de Lewis-Sumner.
    3. Puntuación de al menos 2 en la escala de discapacidad INCAT ajustada.
    4. Paciente que:
    a) nunca antes haya recibido Ig (paciente sin tratamiento previo con Ig)
    O
    b) haya recibido Ig antes, pero padezca una recidiva clínica tras la retirada del tratamiento. En este último caso, el último tratamiento con Ig se debe haber administrado no menos de 3 meses antes de la selección.
    5. Cobertura del sistema nacional de la seguridad social, tal y como exige la normativa local.
    6. Obtención del consentimiento informado por escrito, antes de ningún procedimiento del estudio.
    E.4Principal exclusion criteria
    1. History of severe allergic reaction or serious adverse reaction to any immunoglobulin (Ig).
    2. Clinically documented lack of response to previous Ig treatment.
    3. History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented.
    4. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
    5. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
    6. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident.
    7. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy.
    8. History of personal or familial congenital thrombophilia or acquired thrombophilia.
    9. Factors contributing to venous stasis such as long-term bed confinement.
    10. Body mass Index (BMI) >/= 40 kg/m².
    11. Protein-losing enteropathy characterised by serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria >/= 3.5 g/24hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
    12. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation.
    13. Serum levels of alanine aminotransferase (AST) or aspartate aminotransferase (ALT), >2 times upper limit of normal range.
    1. Antecedentes de reacción alérgica grave o intensa a alguna inmunoglobulina (Ig).
    2. Ausencia de respuesta clínicamente documentada al tratamiento previo con Ig.
    3. Antecedentes de deficiencia de IgA, a menos que se haya documentado la ausencia de anticuerpos anti-IgA.
    4. Hipersensibilidad conocida a la Ig humana o a cualquiera de los excipientes de I10E (glicina y polisorbato 80).
    5. Antecedentes de insuficiencia cardíaca (Asociación de cardiología de Nueva York [New York Heart Association, NYHA] III/IV), arritmia cardíaca no controlada, cardiopatía isquémica inestable o hipertensión no controlada.
    6. Antecedentes de enfermedad tromboembólica venosa, infarto de miocardio o accidente cerebrovascular.
    7. Factor de riesgo de hiperviscosidad de la sangre, como crioglobulinemia o neoplasia hematológica con gammapatía monoclonal.
    8. Antecedentes de trombofilia congénita, familiar o personal, o trombofilia adquirida.
    9. Factores que contribuyan a la insuficiencia venosa, como la obligación de guardar cama durante un período prolongado.
    10. Índice de masa corporal (IMC) >/= 40 kg/m².
    11. Enteropatía con pérdida de proteínas, caracterizada por una proteinemia < 60 g/l y concentración sérica de albúmina < 30 g/l, o síndrome nefrótico, caracterizado por proteinuria >/= 3,5 g/24 horas, proteinemia < 60 g/l y concentración sérica de albúmina < 30 g/l.
    12. Tasa de filtración glomerular < 80 ml/(min·1,73 m²) según la fórmula del grupo MDRD (Modified Diet in Renal Disease).
    13. Concentración sérica de aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 2 veces el límite superior de la normalidad.
    E.5 End points
    E.5.1Primary end point(s)
    Responder rate at EOS visit.
    Responders are defined as patients with a decrease >/= 1 point in the
    adjusted INCAT score between baseline and the EOS visit.
    Tasa de pacientes con respuesta en la visita de FdE.
    Los pacientes con respuesta son aquellos con una reducción >/= 1 punto en la puntuación INCAT ajustada, entre el valor basal y la visita de FdE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline and the End Of Study visit.
    En el momento basal y la visita de Fin de Ensayo.
    E.5.2Secondary end point(s)
    - Responder rate at 12 weeks.
    - Time to response.
    - Percentage of patients at 12 weeks and EOS visit with no change in
    CIDP treatment.
    - Changes from baseline to 12 weeks and EOS visit in the following
    scores:
    o Adjusted INCAT score;
    o Grip strength with the Martin vigorimeter in both hands;
    o Rasch-built Overall Disability Scale (R-ODS);
    o Patient and Investigator Clinical Global Impression (CGI);
    o Medical Research Council (MRC) 12 muscles sum score (0 to 5) and Rasch-modified MRC (0 to 3).
    - Tasa de pacientes con respuesta a las 12 semanas.
    - Tiempo hasta la respuesta.
    - Porcentaje de pacientes a las 12 semanas y en la visita de FdE sin cambios en el tratamiento para la PDIC.
    - Cambio desde el valor basal hasta las 12 semanas y la visita de FdE en las siguientes puntuaciones:
    o Puntuación INCAT ajustada;
    o Fuerza prensil con el vigorímetro de Martin en ambas manos;
    o Puntuación en la Escala de discapacidad global según el modelo de Rasch (Rasch-built Overall Disability Scale, R-ODS);
    o Impresión clínica global (CGI) del investigador y del paciente;
    o Puntuación total en los 12 músculos (0 a 5) del Consejo de investigación médica de Reino Unido (Medical Research Council, MRC) y la MRC modificada según el modelo de Rasch (0 a 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, at 12 weeks and End of study visit
    Momento basal, a las 12 semanas y en la visita de Fin de Ensayo
    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 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
    Other exploratory objectives are:
    - To assess a potential relationship between total serum IgG trough levels, biomarkers levels and clinical changes -as assessed by neurological scales- in patients with CIDP.
    - To assess a potential relationship between US coupled to neurophysiology analysis of nerves and clinical changes -as assessed by neurological scales- in patients with CIDP (ancillary study in
    Italy).
    Otros objetivos exploratorios son:
    - Evaluar una posible relación entre la concentración mínima de IgG total en suero, la concentración de biomarcadores y las alteraciones clínicas (evaluadas mediante escalas neurológicas) en pacientes con PDIC.
    - Evaluar una posible relación entre el análisis de los nervios mediante ECO más neurofisiología y las alteraciones clínicas (evaluadas mediante escalas neurológicas) en pacientes con PDIC (estudio complementario en Italia).
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Brazo único
    Single arm
    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.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    France
    Italy
    Mexico
    Morocco
    Spain
    Tunisia
    Turkey
    United Kingdom
    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
    Ultima visita 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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 42
    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)
    At the last visit patients will be switched to the normal standard of care for the condition.
    En la última visita los pacientes serán pasados al tratamiento estándar para esta condición
    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 Decision2014-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-29
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