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    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-000444-10
    Sponsor's Protocol Code Number:WA28029
    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:2012-09-14
    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 number2012-000444-10
    A.3Full title of the trial
    A STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB
    ESTUDIO PARA EVALUAR LA DISMINUCIÓNDE LA FRECUENCIA DE DOSIS EN PACIENTES CON ARTRITIS IDIOPÁTICA JUVENIL SISTÉMICA ACTIVA (AIJS) QUE EXPERIMENTEN
    ANOMALÍAS DE LABORATORIO DURANTE EL TRATAMIENTO CON TOCILIZUMAB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab
    Estudio para ver la una dosificación menos frecuente en los pacientes con artritis idiopática juvenil sistémica (AIJ), que han experimentado una anomalía de laboratorio durante el tratamiento con tocilizumab
    A.4.1Sponsor's protocol code numberWA28029
    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 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 codeCH-4070
    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
    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.3.4Pharmaceutical 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 INNtocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeRO4877533
    D.3.9.3Other descriptive nameIL-6 receptor inhibitor, recombinant humanized monoclonal antibody
    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 number20
    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
    E.1.1.1Medical condition in easily understood language
    Systemic juvenile idiopathic arthritis (sJIA) is a disorder with onset prior to 16 years of age, which affects the whole body, and causes fever and rashes as well as inflamed and painful joints.
    Artritis idiopática juvenil sistémica es un trastorno con inicio antes de los 16 años, que afecta a todo el cuerpo, y causa fiebre y erupciones cutáneas, y articulaciones inflamadas y dolorosas.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    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
    Efficacy:
    ? To explore the efficacy of TCZ in reduced dosing frequency regimens (Q3W and Q4W, as appropriate) using Juvenile Arthritis Disease Activity Score (JADAS)-71, JIA flare, and fever
    Pharmacodynamic:
    ? To describe the pharmacodynamics, using sIL-6R and C-reactive protein (CRP), and immunogenicity of TCZ in reduced dosing frequency regimens.
    ? Investigar la eficacia de TCZ utilizando regímenes de administración menos frecuentes (C3S y C4S, según corresponda), basándose en la puntuación de la Actividad de la Enfermedad en Artritis Juvenil (JADAS)-71, los períodos de exacerbación de la AIJ y los episodios de fiebre.
    Farmacodinamia
    ? Describir la farmacodinamia basándose en las concentraciones de sIL-6R y proteína C reactiva (PCR) y la inmunogenicidad de TCZ utilizando regímenes de administración menos frecuentes.
    E.2.2Secondary objectives of the trial
    Safety:
    ? To evaluate the safety of TCZ in reduced dosing frequency regimens.
    Pharmacokinetic:
    ? To describe the pharmacokinetics of TCZ in reduced dosing frequency regimens.
    Patient-Reported Outcome:
    ? To describe the Juvenile Arthritis Multidimensional Assessment Report (JAMAR) outcomes with TCZ in reduced dosing frequency regimens.
    ? To describe parent/patient global assessment of disease activity with TCZ in reduced dosing frequency regimens
    ? Evaluar la seguridad de TCZ utilizando regímenes de administración menos frecuentes.
    Farmacocinética
    ? Describir la farmacocinética de TCZ utilizando regímenes de administración menos frecuentes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Age 2 years up to and including 17 years at screening into trial
    ? sJIA according to International League of Associations for Rheumatology (ILAR) classification (2001)
    ? JADAS-71 score of 3.8 or less and absence of fever (related to sJIA) at screening and baseline (Consolaro et al. 2012)
    ? Neutropenia, thrombocytopenia, or elevated ALT/AST (as per defined criteria) previously experienced (and resolved) on the labeled dose (Q2W) of TCZ at any time
    ? Must meet one of the following:
    ? Not receiving MTX or discontinued MTX at least 4 weeks prior to baseline visit, or
    ? Taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of ?20 mg/m2 for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care
    ? Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable dose for a minimum of 2 weeks prior to the baseline visit at no more than 10 mg/day or 0.2 mg/kg/day, whichever is less
    ? Not taking NSAIDs, or taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks prior to the baseline visit, with the dose being less than or equal to the maximum recommended daily dose
    1. Edades comprendidas entre 2 y 17 años, inclusive, en el momento de ser seleccionados para el estudio
    2. AIJs, de acuerdo con la clasificación de la International League of Associations for Rheumatology (ILAR) (2001)
    3. Puntuación JADAS-71 ? 3,8 y ausencia de fiebre (relacionada con AIJs) en el período de selección y basal
    4. Haber manifestado previamente neutropenia, trombocitopenia o elevaciones de ALT/AST (ya resueltas) durante el tratamiento con el régimen de administración autorizado (C2S) de TCZ en cualquier momento
    6. Deben cumplir uno de los criterios siguientes:
    No estar recibiendo metotrexato (MTX) o haber suspendido el tratamiento con este fármaco, como mínimo, 4 semanas antes de la visita basal, o
    Haber recibido MTX durante al menos las 12 semanas inmediatamente anteriores a la visita basal y a una dosis estable de ? 20 mg/m2 como mínimo en las 8 semanas previas a dicha visita, junto con ácido fólico o folínico, de acuerdo con la práctica clínica estándar local
    7. No estar recibiendo en la actualidad corticosteroides orales o estar tomando una dosis estable de corticosteroides orales durante un mínimo de 2 semanas antes de la visita basal, sin que la dosis exceda de 10 mg/día o de 0,2 mg/kg/día, según cual sea menor
    8. No estar recibiendo fármacos antiinflamatorios no esteroideos (AINEs) o no haber sido tratados con más de un 1 tipo de AINE a una dosis estable durante un mínimo de 2 semanas antes de la visita basal y que sea inferior o igual a la dosis diaria máxima recomendada
    9. Haber obtenido el consentimiento informado por escrito para la participación en el estudio de los padres o el tutor legal, con asentimiento por parte del paciente si procede, en función del nivel de entendimiento del paciente
    10. Haber obtenido la aceptación por escrito de los padres o el tutor para cumplir los requisitos del protocolo del estudio
    E.4Principal exclusion criteria
    ? Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA
    ? Any significant concurrent medical or surgical condition which would jeopardize the patient?s safety or ability to complete the trial
    ? Pregnant, lactating, or intending to become pregnant during study conduct and up to 12 weeks after the last administration of study drug
    ? History of significant allergic or infusion reactions to prior TCZ infusion, and/or presence of anti-TCZ antibodies by confirmatory and/or neutralizing assay at screening
    ? Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection including but not limited to:
    a) Acute or chronic renal / bladder infections
    b) Acute or chronic pulmonary infections
    ? Significant cardiac [e.g., congenital heart disease, valvular heart disease, constrictive pericarditis (unrelated to sJIA), myocarditis] or pulmonary disease, (e.g., asthma for which the patient has required the use of oral or parenteral corticosteroids for ? 2 weeks within 6 months prior to the baseline visit, cystic fibrosis)
    ? History of or current cancer or lymphoma
    ? History of MAS within 3 months prior to the screening visit
    1. Cualquier afección significativa concurrente médico o quirúrgico que pueda poner en peligro la seguridad del paciente o la capacidad para completar el ensayo
    2. Cualquier condición médica o quirúrgica concurrente significativa que podría comprometer la seguridad del paciente o su capacidad para completar el estudio.
    3. Pacientes embarazadas, en período de lactancia o que tengan intención de quedarse embarazadas en el transcurso del estudio y hasta 12 semanas después de la administración de la última dosis del fármaco del estudio
    4. Antecedentes de reacciones significativas relacionadas con la infusión o de tipo alérgico a una infusión previa de TCZ y/o presencia de anticuerpos anti-TCZ en un ensayo confirmatorio y/o de detección de anticuerpos neutralizantes realizado en la visita de selección
    5. Cualquier infección fúngica sistémica, viral o bacteriana, recurrente o crónica, aguda o subaguda activa, incluyendo las siguientes, aunque no exclusivamente:
    a. Infecciones renales/de vejiga agudas o crónicas
    b. Infecciones pulmonares agudas o crónicas
    6. Enfermedades cardíacas [p. ej., cardiopatía congénita, valvulopatía, pericarditis constrictiva (no relacionada con AIJs), miocarditis] o pulmonares (p. ej. asma que haya requerido la administración de corticosteroides por vía oral o parenteral durante ? 2 semanas en los 6 meses previos a la visita basal, fibrosis quística) que sean significativas
    7. Antecedentes o presencia de cáncer o linfoma
    8. Antecedentes de síndrome de activación macrofágica (SAM) en los 3 meses previos a la visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    ? JADAS-71 will be utilized to describe efficacy in patients on Q3W and Q4W dosing as appropriate in this study
    ? JIA flare will be used to determine those patients not maintaining efficacy who are to be withdrawn from the study
    ? Fever will be measured at each study visit in patients on Q3W and Q4W dosing (as appropriate) to describe efficacy and to determine patients not maintaining efficacy to be withdrawn from the study

    Pharmacodynamic:
    ? Serum IL-6 and sIL-6R levels and inflammatory markers (CRP and erythrocyte sedimentation rate [ESR])
    ? Anti-TCZ antibodies
    ?JADAS-71, que se utilizará para describir la eficacia en los pacientes tratados C3S o C4S, según corresponda, en este estudio.
    ?Exacerbación de la AIJ, que se utilizará para determinar si los pacientes en los que no se mantenga la eficacia deben ser retirados del estudio.
    ?Fiebre, que se evaluará en cada visita del estudio en los pacientes tratados C3S o C4S (según corresponda), para describir la eficacia y determinar si los pacientes en los que no se mantenga la eficacia deben ser retirados del estudio.
    Farmacodinamicos:
    ?Concentraciones séricas de IL-6 y sIL-6R y marcadores inflamatorios (PCR y velocidad de sedimentación globular [VSG])
    ?Anticuerpos anti-TCZ
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    E.5.2Secondary end point(s)
    Safety:
    ? Adverse events (including adverse events of special interest)
    ? Serious adverse events
    ? Clinical laboratory results

    Pharmacokinetic:
    ? Serum TCZ concentration and population PK model predicted PK exposures (area under the serum concentration-time profile [AUCt], maximum concentration observed [Cmax], and minimum concentration under steady-state conditions within a dosing interval [Cmin]) for Q3W and Q4W dosing regimens as appropriate

    Patient-Reported Outcome:
    ? The JAMAR
    ? Parents/patients global assessment of disease activity
    ?Acontecimientos adversos (incluyendo aquellos que sean de especial interés)
    ?Acontecimientos adversos graves
    ?Resultados de laboratorio clínico
    Farmacocineticos:
    ? Concentración sérica de TCZ y exposiciones FC previstas basándose en un modelo FC poblacional (perfil del área bajo la curva de la concentración sérica-tiempo [AUCt], concentración máxima observada [Cmax] y concentración mínima en estado de equilibrio en un intervalo de administración [Cmin]) para los regímenes de administración C3S y C4S, según corresponda
    Evaluación por el paciente:
    ? JAMAR
    ? Evaluación global de la actividad de la enfermedad realizada por los padres/paciente
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    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 Yes
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Australia
    Canada
    Germany
    Italy
    Mexico
    Norway
    Spain
    Sweden
    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
    The end of the study will occur when the last participating patient completes the last scheduled visit in the study, or if the Sponsor decides to discontinue the study.
    El estudio terminará cuando el último paciente participante complete la última visita planificada del estudio o cuando el promotor decida cancelar el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 20
    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: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Written informed consent for study participation will be obtained from parent or legal guardian, with assent as appropriate by the patient, depending on the level of the patient?s understanding.
    Se obtiene consentimiento informado, por escrito, para la participación en el estudio de los padres o tutor legal, con asentimiento en su caso por el paciente, en función del nivel de comprensión de este.
    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 12
    F.4.2.2In the whole clinical trial 20
    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 does not intend to provide TCZ or other study interventions to patients after conclusion of the study or any earlier patient withdrawal as TCZ is commercially available for sJIA patients, within the countries selected to participate in this trial.
    El Sponsor no tiene la intención de proporcionar TCZ u otras intervenciones del estudio a los pacientes después de la finalización del mismo o a los pacientes que se retiren. TCZ está disponible comercialmente para pacientes AIJ sistémica, en los países seleccionados para participar en este juicio.
    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 Decision2012-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-09
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