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    Summary
    EudraCT Number:2012-003490-26
    Sponsor's Protocol Code Number:WA28118
    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:2013-06-26
    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 number2012-003490-26
    A.3Full title of the trial
    A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS
    ESTUDIO DE FASE Ib, MULTICÉNTRICO, ABIERTO, PARA INVESTIGAR LA FARMACOCINÉTICA, FARMACODINAMIA Y SEGURIDAD DE TOCILIZUMAB TRAS ADMINISTRACIÓN SUBCUTÁNEA A PACIENTES CON ARTRITIS IDIOPÁTICA JUVENIL SISTÉMICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis
    Estudio de una nueva formulación subcutánea de Actemra/RoActemra en niños con
    artritis idiopática juvenil sistémica
    A.4.1Sponsor's protocol code numberWA28118
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/179/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. 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 Information Support Line-TISL
    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.5.6E-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 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 nametocilizumab SC
    D.3.2Product code Ro 487-7533/F10-04
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.2Current sponsor codeRO4877533
    D.3.9.3Other descriptive namerecombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
    D.3.9.4EV Substance CodeSUB20313
    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
    Systemic Juvenile Idiopathic Arthritis (sJIA)
    Artritis idiopatica Juvenil Sistemica (AIJS)
    E.1.1.1Medical condition in easily understood language
    Children with sJIA have arthritis and often have daily fever with rash, in addition to inflammation of the lining of the lung or heart, liver or spleen enlargement, or enlargement of the lymph nodes
    Niños con AIJS tienen artritis y amenudo fiebre diaria con rash, además de
    inflamación de la mucosa de pulmones o corazón, agrandamiento del hígado o bazo, o agrandamiento de los nodulos linfáticos
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    Primary Objective
    - To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with sJIA
    El objetivo farmacocinético (FC) de este estudio es definir la farmacocinética de TCZ SC en pacientes con AIJS.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To evaluate the pharmacodynamics of SC TCZ in patients with sJIA
    - To evaluate the safety of SC TCZ in patients with sJIA

    Exploratory Objective
    To describe the efficacy of SC TCZ in patients with sJIA
    El objetivo farmacodinámico (FD) de este estudio es evaluar la farmacodinamia de TCZ SC en pacientes con AIJS. El objetivo de seguridad de este estudio es evaluar la seguridad de TCZ SC en pacientes con AIJS.
    El objetivo exploratorio de este estudio es describir la eficacia de TCZ SC en pacientes con AIJS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children 1-17 years of age
    - Diagnosis systemic juvenile idiopathic arthritis
    - Inadequate clinical response (in the opinion of the treating physician) to NSAIDs and corticosteroids
    - Concurrent treatment with DMARDs (including methotrexate [MTX]), NSAIDs, and oral corticosteroids is permitted at the discretion of the investigator.
    - Discontinuation of biologic agents (other than tocilizumab if the patient is receiving IV TCZ) for 4 days to 20 weeks prior to baseline depending on biologic agent
    Tener edades comprendidas entre 1 y 17 años
    AIJS diagnosticada
    Haber presentado una respuesta clínica inadecuada (de acuerdo con la opinión del médico responsable del tratamiento) a un tratamiento previo con AINEs y corticosteroides.
    Tratamiento concomitante con DMARDs (incluido MTX) AINEs, y corticosteroides orales, se permiten a criterio del investigador
    Interrupción del tratamiento con agentes biologicos (diferentes a TCZ IV) de 4 días a 20 semanas previas al inicio del tratamiento en función del agente biologico
    E.4Principal exclusion criteria
    - Prior discontinuation of IV TCZ because of inadequate clinical response or safety events
    - Patients with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
    - sJIA that is well controlled by any treatment agent other than TCZ (JADAS-71?3.8 with no fever)
    - Patients who are wheelchair-bound or bedridden
    - Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA
    Suspensión de un tratamiento previo con TCZ IV debido a respuesta clínica inadecuada o problemas de seguridad (incluyendo reacciones de hipersensibilidad).
    Enfermedad mal controlada (de acuerdo con la opinión del médico responsable del tratamiento) a pesar del tratamiento actual con TCZ IV AIJS bien controlada con cualquier agente terapéutico, a excepción de TCZ (puntuación JADAS-71 menor o igual 3,8 en ausencia de fiebre). Pacientes en silla de ruedas o encamados.
    Presentar cualquier otra enfermedad autoinmune, reumática o síndrome de superposición distintos de AIJS
    E.5 End points
    E.5.1Primary end point(s)
    Serum TCZ concentration and population PK model-predicted PK exposures (AUC, Cmax and Cmin) for the QW and Q10D dosing regimens at steady state
    Concentración sérica de TCZ y exposiciones FC previstas basadas en un modelo FC poblacional (área bajo la curva de la concentración-tiempo [AUC], concentración plasmática máxima [Cmax] y Cmin) de los regímenes de administración CS y C10D en estado de equilibrio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Fixed timepoints during the first 14 weeks of the study
    Tiempos fijados durante las primeras 14 semanas del estudio
    E.5.2Secondary end point(s)
    Secondary endpoints:
    - Serum IL-6 and soluble IL-6R (sIL-6R) levels, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR)
    - The incidence and severity of adverse events (including local injection-site reactions) and serious adverse events
    - The incidence and severity of adverse events of special interest
    - The incidence and severity of clinical laboratory abnormalities
    - The incidence of anti-TCZ antibodies

    Exploratory endpoints:
    - Juvenile Arthritis Disease Activity Score (JADAS)-71
    - Inactive disease and clinical remission
    - Childhood Health Assessment Questionnaire (CHAQ)
    Concentraciones séricas de interleuquina 6 (IL-6) y del receptor de IL-6 soluble (sIL-6R), proteína C reactiva (PCR) y velocidad de sedimentación globular (VSG)
    Incidencia de anticuerpos anti-TCZ Incidencia de AA (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
    Las variables de valoración exploratorias de este estudio son las siguientes:
    JADAS-71
    Enfermedad inactiva y remisión clínica
    Childhood Health Assessment Questionnaire (CHAQ)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints:
    - Pharmacodynamic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14]
    - Adverse events, adverse events of special interest and clinical laboratory abnormalities will be recorded for the entire duration of the study [Weeks 0-52]
    - The presence of anti-TCZ antibodies will be evaluated at baseline and at regular intervals with event-driven testing in cases of anaphylaxis, serious hypersensitivity events, or any hypersensitivity event (including non-serious events) leading to treatment withdrawal (at the time of the event and at least 6 weeks after the event)

    Exploratory endpoints:
    - All endpoints will be measured for the duration of the study [Weeks 0-52]
    Se realizarán evaluaciones FC para evaluar los regímenes de administración
    durante las 14 primeras semanas del estudio.
    Los acontecimientos adversos y los acontecimientos adversos de especial interés y anomalías de laboratorio serán registradas durante toda la duración del ensayo (0-52 semanas).
    La presencia de anticuerpos anti-TCZ será evaluada desde el inicio y a intervalos regulares en casos de anafilaxia, hipersensibilidad grave o cualquier evento de hipersensibilidad (incluyendo eventos no graves) hacia el retiro del tratamiento (en el momento del evento y al menos 6 semanas después del evento)
    Variables de evaluación exploratoria: -Todas las variables de evaluación exploratoria se medirán durante la duración del estudio (0-52 semanas)
    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
    dose evaluation in paediatric patients (adaptive design)
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    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
    El estudio terminará cuando el último paciente complete la última visita programada del estudio o si el promotor del mismo decide, por cualquier razón, interumpir el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days21
    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: 48
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 48
    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 evaluate the appropriateness of continuing to provide SC TCZ to study patients after evaluating the data gathered in the study; analyses may be conducted prior to study completion. If the data support the use of SC administration of TCZ to patients with sJIA, the Sponsor will initiate a new study to continue to provide SC TCZ in an open-label extension study to patients who have shown benefit from SC TCZ treatment during this study and who meet specified eligibility criteria.
    El promotor considerará si apropiado continuar suministrando TCZ SC a los pacientes del estudio tras evaluar los datos recogidos en el estudio;análisis pueden ser antes de completar el estudio;Si respaldan el uso de la administración SC de TCZ a los pacientes con AIJS,el promotor iniciará un nuevo estudio,de extensión abierta,para continuar suministrando TCZ SC a los pacientes que se han beneficiado del tto con TCZ SC durante el presente estudio y que cumplan determinados criterios de selección.
    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 Decision2013-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-15
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