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    Summary
    EudraCT Number:2013-005212-98
    Sponsor's Protocol Code Number:WA29231
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-06-09
    Trial 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 number2013-005212-98
    A.3Full title of the trial
    LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS
    Estudio de extensión a largo plazo para evaluar la seguridad y la eficacia de tocilizumab administrado por vía subcutánea en pacientes con artritis idiopática juvenil de curso poliarticular y artritis idiopática juvenil sistémica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.
    Estudio a largo plazo para evaluar la seguridad y la eficacia de tocilizumab administrado por vía subcutánea en pacientes con artritis idiopática juvenil de curso poliarticular y sistémica
    A.4.1Sponsor's protocol code numberWA29231
    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 SponsorRoche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Inform Support -Marta Maislan
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number34913257300
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited 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.3.1Product nametocilizumab SC
    D.3.2Product code Ro 487-7533/F10-04
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNtocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB SC
    D.3.9.4EV Substance CodeSUB122597
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA)
    Artritis idiopática juvenil poliarticular y artritis idiopática juvenil sistémica
    E.1.1.1Medical condition in easily understood language
    pcJIA: arthritis in children causing joint symptoms that can lead to disability. sJIA: arthritis in children often causing fever with rash, organ inflammation (including of lung, heart and liver)
    AIJP puede causar daño en las articulaciones llegando a producir incapacidad AIJS causa frecuentemente fiebre con picor, e inflamación en los organos (incluyendo pulmon, corazón e higado)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    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
    To evaluate the long-term safety of SC administration of TCZ in patients with pcJIA and sJIA
    To describe the long-term efficacy of SC TCZ in patients with pcJIA and sJIA
    Evaluar la seguridad a largo plazo de la administración SC de TCZ en pacientes con AIJcp y AIJs
    Describir la eficacia a largo plazo de tocilizumab (TCZ) subcutáneo (SC) en pacientes con artritis idiopática juvenil de curso poliarticular (AIJcp) y artritis idiopática juvenil sistémica (AIJs)
    E.2.2Secondary objectives of the trial
    Exploratory objectives:
    To assess long-term pharmacodynamics of SC TCZ in patients with pcJIA and sJIA
    To assess long-term pharmacokinetics of SC TCZ in patients with pcJIA and sJIA
    Evaluar la farmacodinamia a largo plazo de TCZ SC en pacientes con AIJcp y AIJs
    Evaluar la farmacocinética a largo plazo de TCZ SC en pacientes con AIJcp y AIJs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Completion of either of the JIGSAW studies, study WA28117 (for patients with pcJIA) or study WA28118 (for patients with sJIA)

    - Adequate disease control with the use of SC RoActemra/Actemra, as assessed by the investigator

    - Written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patients parents or guardian, with assent as appropriate by the patient, depending on the level of the patients understanding

    - For patients of reproductive potential: use of effective contraception as defined by the study protocol
    Haber completado el estudio WA28117 (pacientes con AIJcp) o el estudio WA28118 (pacientes con AIJs)

    Mantener un control adecuado de la enfermedad con el uso de TCZ SC/IV, de acuerdo con el criterio clínico del investigador

    Obtener el consentimiento informado por escrito para participar en el estudio, otorgado por el paciente (si tiene ?18 años) o por sus padres o tutor, con el asentimiento del paciente, si procede, dependiendo del nivel de comprensión del paciente

    Los pacientes en edad fértil deben comprometerse a seguir los métodos anticonceptivos indicados en el protocolo
    E.4Principal exclusion criteria
    - Therapy with biologic agents (except RoActemra/Actemra) in the period between completion of the JIGSAW study and screening for the current study

    - Concurrent treatment with DMARDs (including MTX), NSAIDs, and oral corticosteroids is permitted at the discretion of the investigator

    - Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide, is prohibited

    - Pregnancy or breast-feeding

    - Any significant concurrent medical or surgical conditions or findings that would jeopardize the patients safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection

    - History of alcohol, drug, or chemical abuse within 6 months prior to screening

    - History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening

    - Tratamiento con agentes biológicos (excepto TCZ) en el período comprendido entre la
    terminación del estudio JIGSAW correspondiente y la selección en el estudio actual
    - Está permitido el tratamiento concomitante con fármacos antirreumáticos modificadores
    de la enfermedad (incluyendo metotrexato), antiinflamatorios no esteroideos y corticosteroides orales, de acuerdo con el criterio del investigador.
    - Está prohibida la administración de vacunas vivas o atenuadas e inmunosupresores,
    tales como ciclosporina y ciclofosfamida.
    - Mujeres que estén en período de lactancia
    - Cualquier condición médica o quirúrgica concurrente significativa que pueda comprometer la seguridad del paciente o su capacidad para completar el estudio, incluyendo, aunque no exclusivamente, enfermedades de los sistemas nervioso, renal, hepático, cardíaco,
    pulmonar o endocrino
    - Antecedentes de abuso de alcohol, drogas o sustancias químicas en los 6 meses previos a la visita de selección
    - Antecedentes de tuberculosis (TB) atípica o activa que ha requerido tratamiento en los 2
    años previos a la visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events
    Incidence of serious adverse events
    Incidence of adverse events of special interest
    Incidence of clinical laboratory abnormalities
    Change in Juvenile Arthritis Disease Activity Score (JADAS-71)
    Change in Childhood Health Assessment Questionnaire (CHAQ) score
    Inactive disease/clinical remission
    Incidencia y severidad de los acontecimientos adversos (incluyendo reacciones locales en la zona de inyección) y acontecimientos adversos graves
    Incidencia y severidad de los acontecimientos adversos de especial interés
    Incidencia y severidad de las anomalías de laboratorio clínico
    Puntuación de la Juvenile Arthritis Disease Activity Score (JADAS-71)
    Puntuación del cuestionario Childhood Health Assessment Questionnaire (CHAQ)
    Enfermedad inactiva y remisión clínica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 3 years
    Hasta 3 años
    E.5.2Secondary end point(s)
    The exploratory PK outcome measures will be trough TCZ plasma concentrations measured at specified time-points, and those for PD include Soluble IL-6R (sIL-6R) levels, CRP, ESR , and incidence of anti-TCZ antibodies.
    Concentraciones de IL-6R soluble, proteína C reactiva y velocidad de sedimentación globular
    Incidencia de anticuerpos anti-TCZ
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 years
    Hasta 3 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    long-term extension study
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Canada
    France
    Germany
    Italy
    Mexico
    Peru
    Russian Federation
    Spain
    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 the study will occur when the last patient completes the last scheduled visit of the study or if the Sponsor decides for whatever reason to discontinue the study. Patients will be enrolled in the study until TCZ is commercially available in the applicable region or country. Participation may continue until commercial availability or for a maximum of 3 years.
    El estudio terminará cuando el último paciente complete la última visita planificada del estudio o en caso de que el promotor decida cancelar el estudio por cualquier motivo. Los pacientes serán incluidos en el estudio hasta que TCZ esté disponible comercialmente en la región o el país correspondiente. Cada paciente podrá continuar participando en el estudio hasta que TCZ esté disponible comercialmente o durante un máximo de 3 años, según sea lo que ocurra antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 Yes
    F.1.1Number of subjects for this age range: 96
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 64
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 32
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 96
    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)
    The Sponsor will offer post-trial access to study drug (TCZ) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in the study protocol.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation PRINTO
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation PRCSG
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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