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:2010-022837-27
    Sponsor's Protocol Code Number:CNTO328MCD2002
    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:2012-09-26
    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 number2010-022837-27
    A.3Full title of the trial
    An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease
    Estudio Abierto, Multicéntrico para Valorar la Seguridad del Tratamiento a Largo Plazo de Siltuximab en Sujetos con Enfermedad de Castleman Multicéntrica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's Disease
    Estudio para Valorar la Seguridad del Tratamiento a Largo Plazo de Siltuximab en Sujetos con Enfermedad de Castleman Multicéntrica
    A.4.1Sponsor's protocol code numberCNTO328MCD2002
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)715242166
    B.5.5Fax number+31(0)715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/508
    D.3 Description of the IMP
    D.3.1Product nameCNTO328
    D.3.2Product code CNTO328
    D.3.4Pharmaceutical form Powder 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 INNNA
    D.3.9.1CAS number 541502-14-1
    D.3.9.2Current sponsor codeCNTO328
    D.3.9.3Other descriptive nameSILTUXIMAB
    D.3.9.4EV Substance CodeSUB32552
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100.400
    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 typeAnticuerpo Monoclonal
    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
    Multicentric Castleman's Disease
    Enfermedad de Castleman Multicéntrica
    E.1.1.1Medical condition in easily understood language
    Multicentric Castleman's Disease
    Enfermedad de Castleman Multicéntrica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10050251
    E.1.2Term Castleman's disease
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the long-term safety of siltuximab in subjects with MCD.
    El objetivo principal es evaluar la seguridad a largo plazo del siltuximab en pacientes con enfermedad de Castleman multicéntrica (ECM).
    E.2.2Secondary objectives of the trial
    - To determine the proportion of previously responding subjects who maintain disease control
    - To determine the proportion of siltuximab-naive subjects who experience disease control
    - To describe the duration of disease control and survival
    - To assess reliability of a multicentric Castleman?s disease symptom scale (MCDSS)
    - To evaluate IL-6 levels
    - To assess formation of antibodies to siltuximab (immunogenicity) after long-term treatment in the MCD population
    -Determinar la proporción de pacientes previamente respondedores que mantienen el control de la enfermedad.
    -Determinar la proporción de pacientes sin exposición previa a siltuximab que presenten control de la enfermedad.
    -Describir la duración del control de la enfermedad y la supervivencia.
    -Evaluar la fiabilidad de una escala de síntomas de la enfermedad de Castleman multicéntrica (MCDSS).
    -Evaluar los niveles de IL-6.
    -Evaluar la formación de anticuerpos contra siltuximab (inmunogenicidad) después del tratamiento a largo plazo en la población con ECM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have multicentric Castleman's disease
    - Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm)
    - Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose
    - Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible
    - Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study.
    -Los pacientes deben tener enfermedad de Castleman multicéntrica.
    -Los pacientes deben haber participado previamente en el estudio C0328T03 o CNTO328MCD2001 (en cualquier grupo de tratamiento).
    -Los pacientes deben haber recibido la última administración del tratamiento del estudio (siltuximab o placebo) menos de 6 semanas (margen de +2 semanas) antes de la primera dosis.
    -Los pacientes no deben haber presentado progresión de la enfermedad durante el tratamiento con siltuximab. Para aquellos pacientes asignados originalmente a placebo en el estudio CNTO328MCD2001, también serán elegibles los que hayan recibido siltuximab durante menos de 4 meses después del cambio de tratamiento.
    -Parámetros analíticos adecuados en las 2 semanas previas a la primera dosis de siltuximab en relación con este protocolo
    E.4Principal exclusion criteria
    - Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study
    - Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
    - Known unmanageable allergies, hypersensitivity, or intolerance to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients
    -Toxicidad incontrolable, acontecimiento adverso, progresión de la enfermedad o retirada del consentimiento como motivo de la suspensión del tratamiento en un estudio de siltuximab anterior iniciado por el promotor.
    -Vacunación con vacunas de microorganismos vivos atenuados en las 4 semanas previas a la primera dosis de este estudio.
    -Alergias, hipersensibilidad o intolerancia conocidas y no controlables a anticuerpos monoclonales, a proteínas murinas, quiméricas o humanas o a sus excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients for adverse events as a measure of safety
    La proporcion de pacientes por acontecimientos adversos como medida de seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 5 years
    Hasta 5 años
    E.5.2Secondary end point(s)
    - Proportion of multicentric Castleman's disease (MCD) patients evaluated for pharmacodynamic biomarkers
    - Proportion of previously responding MCD patients and siltuximab-naive patients who maintain disease control
    - Duration of MCD disease control and survival
    - Proportion of patients for Multicentric Castleman's Disease Symptom Scale (MCDSS) as a measure of the severity of symptoms
    - Assessment of glycoform clearance analysis
    - Assessment of in vivo protein degradation analysis
    -La proporción de pacientes con Enfermedad de Castleman Multicéntrica (ECM) evaluados por biomarcadores farmacodinámicos
    -La proporción de pacientes EMC con respuesta previa y sin exposición previa a siltuximab que presenten control de la enfermedad.
    -Duración del control de la enfermedad EMC y la supervivencia
    -La proporción de pacientes con Escala de síntomas de la enfermedad de Castleman multicéntrica (MCDSS) como una medida de la gravedad de los síntomas.
    -Análisis del aclaramiento de formas glucosiladas
    -Analisis de la degradación de la proteína in vivo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5 Years
    Hasta 5 años
    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 Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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
    Brazil
    Canada
    China
    Egypt
    France
    Germany
    Hong Kong
    Israel
    Korea, Republic of
    New Zealand
    Norway
    Singapore
    Spain
    Taiwan
    United Kingdom
    United States
    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
    The end of study is the date of the last assessment for the last subject (eg, last survival follow-up).
    El final del estudio será la fecha de la última evaluación del último paciente (por ejemplo, último seguimiento de la supervivencia).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years5
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 80
    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)
    All subjects will be treated until they progress, withdraw, experience unacceptable toxicity, or until commercial availability of siltuximab in their region, whichever comes first. A data cutoff will occur 4 years after start of enrollment; however, continued drug supply will be ensured for study subjects who would not otherwise have access to siltuximab.
    Se tratará a todos los pacientes hasta que presenten progresión de la enfermedad, se retiren o presenten toxicidad inaceptable o hasta la comercialización de siltuximab en su región, lo que ocurra antes. La fecha de corte de los datos será 4 años después del inicio del reclutamiento; sin embargo, se garantizará un suministro continuado del fármaco para los pacientes del estudio que, de no ser así, no tendrían acceso a siltuximab.
    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 Decision2012-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-01
    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-Tue Apr 23 18:51:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA