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    Summary
    EudraCT Number:2012-000444-10
    Sponsor's Protocol Code Number:WA28029
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000444-10
    A.3Full title of the trial
    A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB
    Studio di fase IV per valutare la riduzione della frequenza di somministrazione di tocilizumab in pazienti affetti da artrite idiopatica giovanile sistemica (sJIA) che manifestano anomalie nei parametri di laboratorio durante il trattamento 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
    Studio per valutare un dosaggio meno frequente di tocilizumab in pazienti con artrite idiopatica giovanile sistemica (sJIA) che manifestano anomalie nei parametri di laboratorio durante il trattamento 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 organisationRoche SpA
    B.5.2Functional name of contact pointCountry Head of Clin Ops Italy
    B.5.3 Address:
    B.5.3.1Street Addressviale Stucchi, 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 039 247 5070
    B.5.5Fax number+39 039 247 5085
    B.5.6E-mailsergio.scaccabarozzi@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 AuthorisationUnited Kingdom
    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.3.9.4EV 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)
    Artrite idiopatica giovanile sistemica (sJIA)
    E.1.1.1Medical condition in easily understood language
    Systemic juvenile idiopathic arthritis (sJIA) is a disorder with onset prior to 16years of age.It affects the whole body and causes fever and rashes as well as inflamed and painful joints
    L'artrite idiopatica giovanile sistemica(sJIA)è un disordine che insorge prima dei16anni; colpisce tutto il corpo e causa febbre,rashes e articolazioni infiammate e doloranti
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    E.1.2System Organ Class 100000004859
    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.
    L’obiettivo primario dello studio è valutare l'efficacia di tocilizumab (TCZ) in regimi a ridotta frequenza di somministrazione (ogni 3 settimane [Q3W] e ogni 4 settimane [Q4W], secondo il caso) in base al punteggio di attività patologica Juvenile Arthritis Disease Activity Score (JADAS)-71, agli episodi di riacutizzazione dell'artrite idiopatica giovanile (JIA) e alla febbre.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of TCZ in reduced dosing frequency regimens. • describe the pharmacodynamics,using soluble interleukin-6 (sIL-6R) and C-reactive protein (CRP), and immunogenicity of TCZ in reduced dosing frequency regimens. • describe the pharmacokinetics of TCZ in reduced dosing frequency regimens.• Patient-Reported Outcome objectives: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
    Obiettivi di sicurezza: •Valutare la sicurezza di TCZ in regimi a ridotta frequenza di somministrazione. Obiettivi di farmacodinamica:•Descrivere la farmacodinamica, basandosi sui valori dell'interleuchina-6 solubile (sIL-6R) e della proteina C reattiva (PCR) e sull'immunogenicità di TCZ in regimi a ridotta frequenza di somministrazione. Obiettivi di farmacocinetica:•Descrivere la farmacocinetica di TCZ in regimi a ridotta frequenza di somministrazione. Obiettivi riferiti agli esiti riportati dal paziente(patient-reported outcome - PRO) dello studio sono:•Descrivere gli esiti del questionario Juvenile Arthritis Multidimensional Assessment Report (JAMAR) associati a regimi a ridotta frequenza di somministrazione di TCZ. •Descrivere la valutazione complessiva del genitore/paziente relativa all'attività patologica associata a regimi a ridotta frequenza di somministrazione di TCZ.
    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
    •Età compresa tra 2 e 17 anni inclusi allo screening •Diagnosi di sJIA in base alla classificazione dell'International League of Associations for Rheumatology (ILAR) (2001) •Punteggio JADAS-71 uguale o inferiore a 3,8 e assenza di febbre (correlata alla sJIA) allo screening e al basale •Precedente manifestazione (e risoluzione) di neutropenia, trombocitopenia o livelli elevati di ALT/AST in qualsiasi momento durante la terapia con TCZ al dosaggio approvato (Q2W) •Fertilità (pazienti di sesso femminile non potenzialmente fertili, oppure potenzialmente fertili che adottino efficaci misure contraccettive, con un test di gravidanza sulle urine negativo nelle 3 settimane precedenti la randomizzazione; oppure pazienti di sesso maschile sterili, oppure non sterili che adottino efficaci misure contraccettive con partner femminili potenzialmente fertili. (Le donne potenzialmente fertili devono utilizzare metodi affidabili di contraccezione [l'astinenza è una possibile opzione] per tutta la durata dello studio e fino a 12 settimane dopo l'ultima infusione del farmaco in studio). •Avere almeno una delle seguenti caratteristiche: non in terapia con metotressato (MTX) o terapia con MTX interrotta almeno 4 settimane prima della visita basale, oppure in terapia con MTX da almeno 12 settimane, immediatamente prima della visita basale, e a una dose stabile  20 mg/m2 da almeno 8 settimane prima della visita basale, unitamente ad acido folico o acido folinico in base allo standard di cura locale •Non essere in terapia con corticosteroidi orali, o con corticosteroidi orali a una dose, stabile da almeno 2 settimane prima della visita basale, non superiore a 10 mg/die o 0,2 mg/kg/die, a seconda di quale sia la più bassa •Non essere in terapia con farmaci antinfiammatori non steroidei (FANS) o in terapia con non più di un tipo di FANS, a una dose stabile da almeno 2 settimane prima della visita basale, con la dose che deve essere inferiore oppure uguale alla massima dose giornaliera raccomandata •Consenso informato scritto per la partecipazione allo studio da ottenere dal genitore o dal tutore legale, con eventuale assenso del paziente, se del caso, in funzione del suo livello di comprensione; accordo scritto del genitore o del tutore a rispettare i requisiti del protocollo di studio.
    E.4Principal exclusion criteria
    GENERAL: Wheelchair bound or bedridden. Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA. Not fully recovered from recent surgery or less than 6 weeks since surgery, at the time of screening visit; or planned surgery during the initial 12 weeks of the study. Lack of peripheral venous access. GENERAL SAFETY:Pregnant, lactating, or intending to become pregnant during study conduct and up to 12 weeks after the last administration of study drug. Any significant concurrent medical or surgical condition which would jeopardize the patient’s safety or ability to complete the trial. 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. Inborn conditions characterized by a compromised immune system. Known HIV infection or other acquired forms of immune compromise. History of alcohol, drug, or chemical abuse within 6 months of screening. Evidence of serious uncontrolled concomitant diseases, including but not limited to the nervous, renal, hepatic, or endocrine systems. Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection including but not limited to: acute or chronic renal / bladder infections and acute or chronic pulmonary infections. History of atypical tuberculosis (TB). Active TB requiring treatment within 2 years prior to the screening visit. Positive purified protein derivative (PPD) at screen (or equivalent result based on local methodology, e.g., Quantiferon gold), unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice. Any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completing within 4 weeks of the screening visit or oral antibiotics completing within 2 weeks of the screening visit. History of reactivation or new onset of a systemic infection, such as herpes zoster or Epstein Barr virus, within 2 months of the screening visit. Hepatitis B surface Antigen or hepatitis C Ab positive. Chronic hepatitis – viral or autoimmune. Significant cardiac or pulmonary disease. History or concurrent serious gastrointestinal (GI) disorders, such as ulcer or inflammatory bowel disease, Crohn’s disease, ulcerative colitis, or other symptomatic lower GI conditions, including ulcer and perforation. History of or current cancer or lymphoma. Uncontrolled diabetes mellitus with elevated Hgb A1c as defined by age-specific standards. History of macrophage activation syndrome (MAS) within 3 months prior to the screening visit. EXCLUDED PREVIOUS or CONCOMITANT THERAPY: Participation in another interventional clinical trial within the past 30 days or 5 serum half-lives of the investigative medication or the PD effect of the investigative medication, whichever is longer. Prior stem cell transplant at any time. Prohibited therapy as described in Section 4.3.2 of the protocol. LABORATORY EXCLUSIONS AT SCREENING: Serum creatinine > 1.5 x upper limit of normal (ULN) (for age and sex). Hemoglobin < 7.0 g/dL (<4.3 mmol/L)
    CRITERI DI CARATTERE GENERALE: Paziente costretto su sedia a rotelle o a letto.Qualsiasi altra malattia reumatica, autoimmune o sindrome concomitante alla sJIA. Recupero non completo da un recente intervento chirurgico oppure non devono essere trascorse meno di 6 settimane da un intervento chirurgico al momento della visita di screening; oppure intervento chirurgico programmato durante le 12 settimane iniziali dello studio.Assenza di accesso venoso periferico. DI SICUREZZA GENERALE:Pazienti di sesso femminile in stato di gravidanza, in allattamento o che pianifichino una gravidanza durante il periodo dello studio e fino a 12 settimane dopo l'ultima somministrazione del farmaco in studio. Qualsiasi affezione medica significativa o chirurgia concomitante che potrebbe pregiudicare la sicurezza del paziente o la sua capacità di completare lo studio. Anamnesi di significativi episodi di allergia o reazioni all'infusione in precedenti infusioni di TCZ e/o presenza di anticorpi anti-TCZ rilevati mediante test di conferma e/o test per la ricerca di anticorpi neutralizzanti allo screening. Patologie congenite caratterizzate da una compromissione del sistema immunitario. Nota infezione da HIV o altre forme di compromissione immunitaria acquisita. Anamnesi di abuso di alcol, farmaci o sostanze chimiche nei 6 mesi precedenti lo screening. Evidenza di gravi patologie concomitanti non adeguatamente controllate, tra cui ad esempio patologie a carico del sistema nervoso, renale, epatico o endocrino. Qualsiasi infezione acuta, subacuta, cronica o recidivante di origine batterica, virale o fungina sistemica. Anamnesi di tubercolosi (TB) atipica. TB attiva che abbia richiesto un trattamento nei 2 anni precedenti la visita di screening. Positività del derivato proteico purificato (PPD) allo screening (o risultato equivalente in base alla metodica locale, per es. Quantiferon TB gold), eccetto pazienti sottoposti a terapia anti-TB da almeno 4 settimane prima della somministrazione del farmaco in studio e radiografia toracica negativa per TB attiva nei 6 mesi precedenti la visita di screening, in base alla prassi locale. Qualsiasi episodio maggiore di infezione che richieda un ricovero oppure una terapia durante lo screening, oppure un trattamento con antibiotici e.v. completato nelle 4 settimane precedenti la visita di screening, oppure antibiotici orali completati nelle 2 settimane precedenti la visita di screening. Anamnesi di riattivazione o nuovo esordio di infezione sistemica, ad esempio da virus herpes zoster o Epstein Barr, nei 2 mesi precedenti la visita di screening. Positività dell'antigene di superficie dell'epatite B o degli anticorpi anti-epatite C. Epatite cronica - virale o autoimmune. Significativa cardiopatia o pneumopatia. Anamnesi o presenza attuale di disturbi gastrointestinali (GI) seri, quali ulcera o malattia infiammatoria intestinale, morbo di Crohn, colite ulcerosa o altre patologie sintomatiche del basso apparato GI, incluse ulcera e perforazione. Anamnesi o presenza concomitante di tumore o linfoma. Diabete mellito non adeguatamente controllato, con elevati livelli di Hgb A1c in base agli standard specifici per l'età. Anamnesi di sindrome da attivazione dei macrofagi (MAS) nei 3 mesi precedenti la visita di screening. TERAPIE, PRECEDENTI O CPNCOMITANTI, PROIBITE: Partecipazione a un altro studio clinico interventistico negli ultimi 30 giorni o 5 emivite sieriche del medicinale sperimentale, oppure effetto farmacodinamico del farmaco sperimentale: a seconda di quale sia il più lungo. Precedente trapianto di cellule staminali, in qualsiasi momento. Terapie proibite, così come illustrate nel paragrafo 4.3.2 del protocollo. ESCLUSIONI SUI PARAMETRI DI LABORATORIO ALLO SCREENING: Creatinina sierica&gt;1,5 x il limite superiore della norma (ULN) (per età e sesso). Emoglobina &lt;7,0 g/dl (&lt;4,3 mmol/l)
    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
    Le misure di valutazione dell'efficacia sono:• Lo strumento JADAS-71 sarà utilizzato per descrivere l'efficacia nei pazienti sottoposti ai regimi di somministrazione Q3W e Q4W, secondo il caso;
    • Gli episodi di riacutizzazione di JIA saranno usati per stabilire quali pazienti che, non mantenendo l’efficacia, dovranno essere ritirati dallo studio;
    • La temperatura corporea sarà rilevata a ogni visita di studio nei pazienti in regime di somministrazione Q3W e Q4W (secondo il caso) per illustrare l'efficacia e stabilire quali pazienti non avranno mantenuto l'efficacia e dovranno essere ritirati dallo studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 settimane
    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
    Misure di valutazione della sicurezza: • Eventi avversi (inclusi gli eventi avversi di interesse speciale);
    • Eventi avversi seri;
    • Risultati degli esami clinici di laboratorio.
    Misure di valutazione degli esiti di farmacodinamica e farmacocinetica PK/PD: • Concentrazione sierica di TCZ ed esposizioni PK previste in base al modello di farmacocinetica di popolazione (profilo dell’area sottesa alla curva di concentrazione sierica-tempo [AUC], massima concentrazione osservata [Cmax], e minima concentrazione in stato stazionario con una data frequenza di somministrazione [Cmin]) per i regimi di somministrazione Q3W e Q4W, secondo il caso;
    • Livelli sierici di IL-6 e sIL-6R e marker dell'infiammazione (PCR e velocità di sedimentazione eritrocitaria [VES]);
    • Anticorpi anti-TCZ.
    Misure di valutazione degli esiti riferiti dal paziente(PRO):• Il questionario JAMAR;
    • La valutazione complessiva del genitore/paziente sull’attività della malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 settimane
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicità
    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 Yes
    E.8.1.7.1Other trial design description
    studio per valutare la riduzione della frequenza di somministrazione
    This is a study to look at reducing dosing frequency.
    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 concerned4
    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
    Mexico
    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.
    Lo studio terminerà quando l'ultimo paziente partecipante completerà l'ultima visita programmata dello studio, oppure qualora lo Sponsor decidesse di interrompere lo studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months39
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months39
    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.
    Consenso informato scritto per la partecipazione allo studio da ottenere dal genitore o dal tutore legale, con eventuale assenso del paziente, se del caso, in funzione del suo livello di comprensione
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    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.
    Lo sponsor non fornirà il TCZ ai pazienti dopo la conclusione dello studio o a pazienti che sono usciti in anticipo dallo studio, in quanto il TCZ è disponibile in commercio per i pazienti con sJIA nei pazienti selezionati per partecipare allo studio.
    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 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation PRCSG
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-09
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