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    Summary
    EudraCT Number:2011-001442-15
    Sponsor's Protocol Code Number:FTY720D2324
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-27
    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 number2011-001442-15
    A.3Full title of the trial
    A 32-week, patient- and rater-blinded, randomized, multicenter, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720)
    Studio multicentrico, randomizzato, con paziente e valutatore in condizioni di cecita', a gruppi paralleli, della durata di 32 settimane per valutare il controllo della malattia e la sicurezza in pazienti con sclerosi multipla recidivante-remittente che hanno subito la conversione da un precedente trattamento con natalizumab al trattamento con fingolimod (FTY720)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate disease control and safety in patients with RRMS (relapsing remitting multiple sclerosis) switching from natalizumab to fingolimod
    Uno studio per valutare il controllo della malattia e la sicurezza in pazienti con RRMS (sclerosi multipla recidivante-remittente)passando dal natalizumab al fingolimod
    A.4.1Sponsor's protocol code numberFTY720D2324
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNovartis
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 Gilenya
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFINGOLIMOD
    D.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720
    D.3.9.3Other descriptive nameGYLENIA
    D.3.9.4EV Substance CodeSUB30967
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsing remitting multiple sclerosis
    sclerosi multipla recidivante-remittente
    E.1.1.1Medical condition in easily understood language
    relapsing remitting multiple sclerosis
    sclerosi multipla recidivante-remittente
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate disease control during different lengths of treatment transition from natalizumab to fingolimod from the last natalizumab infusion through 8 weeks of fingolimod treatment.
    Valutare il controllo della malattia nel corso di periodi di transizione di diversa durata da natalizumab a fingolimod, misurato mediante il numero di lesioni T2 attive (nuove o di nuova estensione) dall’ultima infusione di natalizumab per 8 settimane di trattamento, aggiustato per il tempo di osservazione.
    E.2.2Secondary objectives of the trial
    To evaluate disease control during different lengths of treatment transition from natalizumab to the initiation of fingolimod treatment. To evaluate disease control after different lengths of treatment transition from natalizumab during the first 8 weeks of fingolimod treatment.
    Valutare il controllo della malattia nel corso di periodi di transizione di diversa durata da natalizumab a fingolimod,misurato mediante il numero di lesioni T2 attive (nuove o di nuova estensione) dall’ultima infusione di natalizumab all’inizio del trattamento con fingolimod,aggiustato per il tempo di osservazione.Valutare il controllo della malattia nel corso di periodi di transizione di diversa durata da natalizumab a fingolimod,misurato mediante il numero di lesioni T2 attive (nuove o di nuova estensione) dall’ultima infusione di natalizumab durante le prima 8 settimane di trattamento con fingolimod.Per maggiori dettagli consultare il capitolo 2 del protocollo originale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Must have relapsing remitting multiple sclerosis and must be on treatment with natalizumab for at least 6 months prior to screening where discontinuation of treatment is considered for the following reasons: - Treatment duration for more than 2 years - Positive JCV antibody status - Pretreatment with immunosuppressive agents - Adverse events, including hypersensitivity reactions - Presence of anti-natalizumab neutralizing antibodies - Any other valid medical reason
    Criteri di inclusione • Consenso informato scritto ottenuto prima dell’effettuazione di qualsiasi procedura • Soggetti di sesso maschile o femminile di eta` compresa tra i 18 e i 65 anni • Pazienti con sclerosi multipla recidivante-remittente (RRMS) definita secondo i criteri McDonald nella revisione del 2010 • Pazienti con punteggio 0-6.0 (estremi inclusi) nella Expanded Disability Status Scale (EDSS) • Pazienti in trattamento con natalizumab da almeno 6 mesi prima dello screening ai quali potrebbe essere sospeso il trattamento per le seguenti motivazioni: - Durata del trattamento per piu` di due anni - Positivita` all’anticorpo contro il JCV virus - Pretrattamento con farmaci immunosoppressori - Eventi avversi, comprese le reazioni di ipersensibilita` - Presenza di anticorpi neutralizzanti natalizumab - Altre valide motivazioni cliniche L’ultima infusione deve avvenire entro 1 settimana dalla randomizzazione
    E.4Principal exclusion criteria
    Patients with a type of MS that is not relapsing, Patients with history of chronic immune disease, crohns disease, certain cancers or uncontrolled diabetes, patients with certain eye disorders, patients who are on certain immunosuppressive medications or heart medications, patients with certain heart conditions, patients with certain lung conditions. Other protocol-defined inclusion/exclusion criteria may apply
    • Pazienti con malattia di Chron o colite ulcerosa • Pazienti che sono stati trattati con: o corticosteroidi o immunoglobuline nel mese precedente la randomizzazione o farmaci immunosoppressivi come azatioprina, ciclofosfamide o metotrexato nei 3 mesi precedenti la randomizzazione o anticorpi monoclonali (escluso natalizumab) nei 3 mesi precedenti la randomizzazione o cladribina o mitoxantrone in qualsiasi momento • Storia di malignita` di un qualsiasi sistema d’organo (ad eccezione del carcinoma cutaneo basocellulare in situ) • Diabete mellito non controllato (HbA1c&gt;7%) • Diagnosi di edema maculare durante la fase di screening (i pazienti con storia di edema maculare potranno entrare nello studio a condizione che non presentino edema maculare alla visita di screening) • Infezioni severe attive, infezioni croniche attive • Negativita` per gli anticorpi IgG del virus della varicella-zoster prima della randomizzazione • Pazienti con una qualsiasi delle seguenti condizioni e/o esiti cardiovascolari risultanti dall’ECG allo screening: o storia di arresto cardiaco o infarto miocardico nei 6 mesi precedenti la Visita 1 o con patologia cardiaca ischemica instabile in atto o storia di angina pectoris dovuta a spasmo coronarico o insufficienza cardiaca (Classe III-IV, secondo la classificazione della New York Heart Association) o patologia cardiaca grave a giudizio dello sperimentatore o storia o presenza di blocco atrioventricolare di secondo grado – Mobitz 2 o blocco atrioventricolare di terzo grado o intervallo QTc &gt;450 ms negli uomini e &gt;470 ms nelle donne corretto utilizzando la formula di Bazett nel referto della lettura centralizzata dell’ECG o pazienti che assumono farmaci antiaritmici di classe Ia (ajmalina, disopiramide, procainamide, chinidina) e di classe III (ad es. amiodarone, bretilio, sotalolo, ibulitide, azimilide, dofelitide) o storia documentata di sindrome del seno malato o di blocco cardiaco seno-atriale o ipertensione non controllata • Pazienti con malattia respiratoria severa, fibrosi polmonare o malattia polmonare cronica ostruttiva (Classe III-IV) • Pazienti con una delle seguenti patologie epatiche: o danno epatico severo (Child-Pugh classe C) o bilirubina totale superiore a 2 volte il limite di normalita`, se non nel contesto della sindrome di Gilbert o bilirubina coniugata superiore a 2 volte il limite di normalita` o AST (SGOT), ALT (SGPT) superiori a 2 volte il limite di normalita` o fosfatasi alcalina (AP) superiore a 2 volte il limite di normalita` o gamma-glutamil-transferasi (GGT) superiore a 2 volte il limite di normalita` • Pazienti con conta dei globuli bianchi (WBC) &lt;3,500/mm3 o conta linfocitica &lt;800/mm3 allo screening • Pazienti non in grado di sottoporsi alla RMN, compresi pazienti claustrofobici o con storia di ipersensibilita` al gladolinio-DTPA • Precedente partecipazione ad uno studio clinico con fingolimod Per maggiori dettagli consultare i paragrafi 4.1 e 4.2 del protocollo originale.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate disease control through MRI
    Valutazione del controllo della malattia attraversso la Ressonanza magnetica
    E.5.1.1Timepoint(s) of evaluation of this end point
    16, 20 or 24 weeks as applicable per arm
    16, 20 or 24 settimane come applicabile per braccio
    E.5.2Secondary end point(s)
    To evaluate disease control through MRI
    Valutazione del controllo della malattia attraversso la Ressonanza magnetica
    E.5.2.1Timepoint(s) of evaluation of this end point
    8, 12 or 16 weeks as applicable per arm
    8, 12 or 16 settimane come applicabile per braccio
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Israel
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV : 22/MAY/2013
    LPLV : 22/05/2013
    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 months19
    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 months22
    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 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 588
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 585
    F.4.2.2In the whole clinical trial 600
    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)
    FTY720 is registered in all countries participating in this study. This
    would allow patients to continue therapy on either FTY720 or any other
    medication. In case patients wants to continue therapy on FTY720 and
    the drug is not yet commercially available in the respective country, the
    patient can enter a long term extension study 2399.
    FTY720 è registrato in tutti i paesi che partecipano a questo studio. Ciò
    permetterebbe che i pazienti continuino la terapia con FTY720 o con qualsiasi altro farmaco. Nel caso i pazienti volessero continuare la terapia con FTY720 e il farmaco non fosse ancora disponibile in commercio nel rispettivo paese,il paziente può entrare nello studio di estensione a lungo termine 2399.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-11-29
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