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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38569   clinical trials with a EudraCT protocol, of which   6334   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).
     
    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:2018-001931-27
    Sponsor's Protocol Code Number:STARS-trial
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-10-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001931-27
    A.3Full title of the trial
    Comparison of STep-up and step-down therapeutic strategies in childhood ARthritiS
    Confronto di strategie terapeutiche step-up e step-down nell'artrite idiopatica giovanile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of therapeutic strategies in childhood ARthritiS
    Confronto di strategie terapeutiche nell'artrite idiopatica giovanile
    A.3.2Name or abbreviated title of the trial where available
    the STARS trial
    the STARS trial
    A.4.1Sponsor's protocol code numberSTARS-trial
    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 SponsorIRCCS Istituto Giannina Gaslini
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAIFA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportCompagnia di San Paolo
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPRINTO
    B.5.2Functional name of contact pointPRINTO
    B.5.3 Address:
    B.5.3.1Street AddressVia Gaslini5
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16147
    B.5.3.4CountryItaly
    B.5.4Telephone number003901056362795
    B.5.5Fax number00390104211018
    B.5.6E-mailprinto@gaslini.org
    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 Reumaflex
    D.2.1.1.2Name of the Marketing Authorisation holderAlfasigma
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for infusion 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 INNMETHOTREXATE
    D.3.9.1CAS number 59-05-2
    D.3.9.2Current sponsor codeMETHOTREXATE
    D.3.9.3Other descriptive nameMETHOTREXATE
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder and solution for 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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.2Current sponsor codeETANERCEPT
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    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
    Juvenile idiopathic arthritis (JIA) is an umbrella term that encompasses a heterogeneous group of disorders characterised by prolonged synovial inflammation that may cause destructive damage to joint structures. Permanent changes may also develop in extraarticular organs, particularly the eye (as a complication of chronic anterior uveitis), or may result from side effects of medications.
    L’artrite idiopatica giovanile (AIG) è una malattia cronica caratterizzata da infiammazione persistente alle articolazioni; i segni tipici di infiammazione alle articolazioni sono dolore, gonfiore e limitazione dei movimenti. "Idiopatica" significa che non conosciamo la causa della malattia e "giovanile", in questo caso, significa che l’inizio dei sintomi di solito avviene prima dei 16 anni d’età.
    E.1.1.1Medical condition in easily understood language
    Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent inflammation of the joints, pain, swelling and limitation of motion.
    L’artrite idiopatica giovanile (AIG) è una malattia cronica caratterizzata da infiammazione persistente alle articolazioni, dolore, gonfiore e limitazione dei movimenti.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059177
    E.1.2Term Juvenile arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is aimed to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (Step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on a combination of conventional and biological DMARDs (Step-down strategy).
    The hypothesis tested in this trial is whether an early aggressive therapy with a 6-month course of an anti-TNF agent in combination with methotrexate or with methotrexate alone in the milder forms of oligoarthritis (Step-down arm) is more effective in inducing clinical remission on medication (i.e. at least 6-month of continuous inactive disease while receiving anti-rheumatic medications) than a conventional therapeutic approach based on treatment escalation (Step-up arm), which efficacy is maximized through the implementation of a treat-to-target approach
    Obiettivo dello studio è confrontare l’efficacia nell’indurre uno stato di remissione di malattia persistente di due diverse strategie terapeutiche per l’AIG: l’avvio precoce di un breve ciclo di terapia massimale combinata (Step-down) e una terapia convenzionale basata sulla progressiva intensificazione del trattamento e ottimizzata con un approccio treat-to-target (Step-up).
    E.2.2Secondary objectives of the trial
    • Inactive disease
    The rate of patients who achieve the JADAS/JIA ACR state of ID at any single point in time throughout the study period will be compared between the 2 arms.
    • Time to inactive disease as per JADAS/JIA ACR criteria
    Time to achieve the JADAS/JIA ACR state of ID will be calculated as the time difference (in days) between the date of randomization and the date of the visit at which the patient will be observed to be in ID.
    • Time to JADAS/JIA ACR clinical remission
    Time to achieve the JADAS/JIA ACR state of clinical remission will be calculated as the time difference (in days) between the date of randomization and the date of the visit at which the patient will be observed to be in clinical remission (i.e. persistent inactive disease for at least 6 months).
    • malattia inattiva
    Il tasso di pazienti che raggiungono lo stato di malattia inattiva JADAS / JIA ACR in un preciso momento nel tempo durante lo studio sarà confrontato tra i 2 bracci.
    • Tempo di malattia inattiva secondo i criteri JADAS / JIA ACR
    Il tempo necessario per ottenere lo stato di malattia inattiva secondo i criteri JADAS / JIA ACR verrà calcolato come differenza in giorni tra la data di randomizzazione e la data della visita in cui la malattia del paziente verrà definita come inattiva.
    • Tempo per la remissione clinica JADAS / JIA ACR
    Il tempo necessario per ottenere lo stato di remissione clinica della malattia secondi i criteri JADAS / JIA ACR sarà calcolato come differenza in giorni tra la data di randomizzazione e la data della visita in cui la malattia del paziente sarà definita in remissione clinica (es. persistente malattia inattiva per almeno 6 mesi).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I. Newly-diagnosed and synthetic or biologic DMARD-naïve children (only treatment with 1 NSAID is allowed and no corticosteroid joint injections prior to randomization ) with a JIA classified according to the following ILAR categories:
    i. Oligoarthritis
    ii. Rheumatoid factor negative polyarthritis
    II. Active arthritis
    III. Onset of JIA symptoms no more than 6 months before randomization
    IV. Age 2 to 17 years at enrolment.
    V. Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial, and then every 3 months. If sexually active, they must agree to use adequate contraception, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use adequate birth control methods if sexually active.
    VI. Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate
    VII. Duly executed, written, informed consent/assent obtained from the parents/patient.
    Bambini appena diagnosticati e mai trattati con farmaci sintetici o biologci DMARD (è consentito solo il trattamento con 1 FANS e nessuna iniezione di corticosteroidi prima della randomizzazione) con una diagnosi di AIG secondo le seguenti categorie ILAR:
    io. Oligoartrite
    ii. Poliartrite da fattore reumatoide negativo
    II. Artrite attiva
    III. Inizio dei sintomi AIG non più di 6 mesi prima della randomizzazione
    IV. Età da 2 a 17 anni all'arruolamento.
    V. I pazienti di sesso femminile in età fertile devono avere un test di gravidanza negativo all'inizio dello studio e successivamente ogni 3 mesi. Se sessualmente attivi, i pazienti devono accettare di utilizzare una contraccezione adeguata, durante la partecipazione allo studio, e non devono avere intenzione di concepire durante il corso dello studio. I maschi post-puberali non devono avere intenzione di concepire un figlio durante lo studio e devono esprimere il proprio consenso ad usare adeguati metodi anticoncezionali se sessualmente attivi.
    VI. Capacità di rispettare tutte le procedure dello studio, capacità di comunicare efficacemente con lo staff medico, deve avere le capacità di esprimere il proprio consenso informato in forma scritta; da sottoporre ai genitori e / o ai pazienti, a seconda dei casi
    VII. Consenso / assenso informato debitamente compilato e firmato, ottenuto dai genitori / paziente.
    E.4Principal exclusion criteria
    I. Classification in one of the following JIA categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis
    II. Patients who need systemic treatment for uveitis
    III. Tuberculosis related issues: patients are excluded from the study if they have:
    a. Active TB or a history of incompletely treated TB
    b. PPD or QuantiFERON-TB positive patients (with no active disease) unless it is documented by a specialist that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the study investigator and / or an infectious disease specialist.
    c. Suspected extrapulmonary TB infection
    d. Patients at high risk of contracting TB, such as close contact with individual with active or latent TB
    IV. Previous treatment with any synthetic or biologic DMARD
    V. Any live attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines and throughout the study. Killed or inactive vaccine may be permitted based on the investigator’s judgment
    VI. Prior or current history of malignancy or any other significant concomitant illness(es) as per the treating physician evaluation

    I. Classificazione in una delle seguenti categorie AIG: artrite sistemica, poliartrite FR-positivo, artrite psoriatica, artrite assocoata ad entesite, artrite indifferenziata
    II. Pazienti che necessitano di un trattamento sistemico per l'uveite
    III. Problemi legati alla tubercolosi: i pazienti sono esclusi dallo studio se hanno:
    una TB attiva o una storia di TB non completamente guarita
    b. Pazienti positivi ai test PPD o QuantiFERON-TB (senza malattia attiva) a meno che non sia documentato da uno specialista che il paziente è stato adeguatamente trattato per la TB e può iniziare il trattamento con un agente biologico, sulla base del giudizio medico dello sperimentatore dello studio e / o di uno specialista in malattie infettive.
    c. Sospetta infezione da TB extrapolmonare
    d. Pazienti ad alto rischio di contrarre la tubercolosi, come stretto contatto con individui con TB attiva o latente
    IV. Trattamento precedente con qualsiasi DMARD sintetico o biologico
    V. Qualsiasi vaccino vivo attenuato fatto entro 4 settimane prima della visita basale, come varicella-zoster, poliomielite orale, morbillo, parotite o rosolia e durante lo studio. Il vaccino ucciso o inattivo può essere autorizzato sulla base del giudizio dello sperimentatore
    VI. Anamnesi positiva o precedente di neoplasie maligne o di qualsiasi altra malattia concomitante significativa secondo la valutazione del medico curante
    E.5 End points
    E.5.1Primary end point(s)
    • Inactive disease
    The rate of patients who achieve the JADAS/JIA ACR state of ID at any single point in time throughout the study period will be compared between the 2 arms.
    • Time to inactive disease as per JADAS/JIA ACR criteria
    Time to achieve the JADAS/JIA ACR state of ID will be calculated as the time difference (in days) between the date of randomization and the date of the visit at which the patient will be observed to be in ID.
    • Time to JADAS/JIA ACR clinical remission
    Time to achieve the JADAS/JIA ACR state of clinical remission will be calculated as the time difference (in days) between the date of randomization and the date of the visit at which the patient will be observed to be in clinical remission (i.e. persistent inactive disease for at least 6 months).
    • malattia inattiva
    Il tasso di pazienti che raggiungono lo stato di malattia inattiva JADAS / JIA ACR in un preciso momento nel tempo durante lo studio sarà confrontato tra i 2 bracci.
    • Tempo di malattia inattiva secondo i criteri JADAS / JIA ACR
    Il tempo necessario per ottenere lo stato di malattia inattiva secondo i criteri JADAS / JIA ACR verrà calcolato come differenza in giorni tra la data di randomizzazione e la data della visita in cui la malattia del paziente verrà definita come inattiva.
    • Tempo per la remissione clinica JADAS / JIA ACR
    Il tempo necessario per ottenere lo stato di remissione clinica della malattia secondi i criteri JADAS / JIA ACR sarà calcolato come differenza in giorni tra la data di randomizzazione e la data della visita in cui la malattia del paziente sarà definita in remissione clinica (es. persistente malattia inattiva per almeno 6 mesi).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated at 3, 6, 9, 12 months after enrollment.
    I pazienti verranno valutati a 3, 6, 9, 12 mesi dopo l’arruolamento.
    E.5.2Secondary end point(s)
    • Inactive disease

    • Time to inactive disease as per JADAS/JIA ACR criteria

    • Time to JADAS/JIA ACR clinical remission

    • Time spent in JADAS/JIA ACR inactive disease
    • malattia inattiva

    • Tempo di malattia inattiva secondo i criteri JADAS / JIA ACR

    • Tempo per la remissione clinica JADAS / JIA ACR

    • Tempo trascorso in malattia inattiva JADAS / JIA ACR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated at 3, 6, 9, 12 months after enrollment.
    I pazienti verranno valutati a 3, 6, 9, 12 mesi dopo l’arruolamento.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    confronto di strategie terapeutiche
    therapeutic strategies are compared
    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 concerned50
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 260
    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: 130
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 130
    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 No
    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
    pediatric patients
    pazienti pediatrici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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)
    After the conclusion of the 12-month observation period of the trial, patients will be followed for up to 5 years for the evaluation of disease course, medication requirements, adverse events, and long-term disease-related morbidity.
    Dopo la conclusione del periodo di osservazione di 12 mesi dello studio, i pazienti verranno seguiti per un massimo di 5 anni per la valutazione del decorso della malattia, dei farmaci, degli eventi avversi e della morbilità correlata alla malattia a lungo termine.
    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 - IRCCS Giannina Gaslini
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-05
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA