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    Summary
    EudraCT Number:2011-000770-60
    Sponsor's Protocol Code Number:CFTY720DIT03
    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:2011-09-01
    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 number2011-000770-60
    A.3Full title of the trial
    “An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists”
    Studio in aperto, multicentrico, di accesso allargato a fingolimod in pazienti con sclerosi multipla recidivante-remittente, per i quali non esiste una adeguata alternativa terapeutica
    A.3.2Name or abbreviated title of the trial where available
    ND
    ND
    A.4.1Sponsor's protocol code numberCFTY720DIT03
    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 Farma SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma SpA
    B.5.2Functional name of contact pointMultiple Sclerosis Unit
    B.5.3 Address:
    B.5.3.1Street AddressL.go Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number0296542752
    B.5.5Fax number029659066
    B.5.6E-mailVIRGINIO.OLDANI@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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namefingolimod
    D.3.2Product code FTY720D
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNother nervous system drugs
    D.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFINGOLIMOD
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
    circa 600 pazienti con SM recidivante-remittente per i quali non esista terapia idonea, cioe' quando le terapie esistenti hanno fallito.
    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 14.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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
    The objectives of the study are: - provide early access to fingolimod to patients who have been diagnosed with relapsing-remitting multiple sclerosis and for whom no suitable therapy exists i.e where existing therapies have failed. - generate additional safety and tolerability data, according to the label recommended by CHMP, in a population resembling that of future clinical practice.
    - offrire accesso allargato al trattamento con fingolimod ai pazienti in cui sia stata diagnosticata una sclerosi multipla recidivante-remittente e per i quali non vi sia terapia adeguata ,cioe' quando le terapie esistenti hanno fallito. - generare dati di sicurezza e tollerabilita' aggiuntivi, seguendo le indicazioni approvate dal CHMP, in una popolazione che assomiglia a quella identificabile nella futura pratica clinica.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this program have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Male or female patients aged at least 18 years old 3. Patients with relapsing-remitting MS 4. Patients for whom no suitable treatment alternative exists i.e where alternative therapy has failed. 5. An Expanded Disability Status Scale (EDSS) score of 0-6.5 inclusive 6. Patients previously treated with natalizumab may be considered for inclusion only after a wash-out period of at least 3 months following discontinuation of natalizumab
    I pazienti eleggibili per l’inclusione in questo programma devono soddisfare tutti i seguenti criteri: 1) Il consenso informato scritto deve essere ottenuto prima che sia stato condotto qualsiasi accertamento 2) Pazienti di entrambi i sessi, di almeno 18 anni di eta' 3) Pazienti con SM recidivante-remittente 4) Pazienti per i quali non esista un trattamento adeguato, vale a dire dove le terapie alternative hanno fallito 5) Punteggio EDSS (Expanded Disability Status Scale) di 0-6.5, compresi gli estremi dell’intervallo 6) Pazienti precedentemente trattati con natalizumab potranno essere presi in considerazione per l’inclusione solo dopo un periodo di wash-out di almeno 3 mesi dall’interruzione di natalizumab
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. History of chronic disease of the immune system other than MS or a known immunodeficiency syndrome 2. History or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin) 3. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy or uncontrolled diabetic patients with HbA1c>8% 4. Diagnosis of macular edema (patients with a history of macular edema will be allowed to enter the program provided that they do not have macular edema at the first visit). 5. Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively 6. Patients who have no history of chickenpox and test negative for varicella-zoster virus IgG antibodies at the first visit (such patients should be considered for VZV vaccination and may be included ≥ 1 month after vaccination) 7. Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to the first visit 8. Patients who have received total lymphoid irradiation or bone marrow transplantation 9. Patients who have been treated with: • corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to the first visit • immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to the first visit • immunoglobulins and/or monoclonal antibodies (including natalizumab) within at least 3 months prior to inclusion • cladribine, cyclophosphamide or mitoxantrone at any time 10. Any of the following cardiovascular conditions: • cardiac failure at time of the first visit (Class III, according to NYHA Classification) or any severe cardiac disease as determined by the physician • resting heart <45 bpm at time of the first visit • myocardial infarction within the previous 6 months • history or presence of a third degree AV block • history of Mobitz Type II second degree AV block • proven history of sick sinus syndrome or sino-atrial heart block • arrhythmia requiring current treatment with Class Ia (ajmaline, disopyramide, procainamide, quinidine) or Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide) • hypertension, uncontrolled by medication 11. Any of the following pulmonary conditions: • severe respiratory disease or pulmonary fibrosis • uncontrolled asthma 12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) 13. Any of the following hepatic conditions: • known history of alcohol abuse, chronic liver or biliary disease, severe hepatic impairment (Child-Pugh class C) • total bilirubin greater than the upper limit of the normal range unless in context of Gilbert’s syndrome • conjugated bilirubin greater than the upper limit of the normal range • alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range • AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range gamma-glutamyl-transferase (GGT) greater than 3 times the upper limit of the normal range
    I pazienti che rispondono ad uno qualsiasi dei seguenti criteri non sono eleggibili per l’inclusione in questo studio: 1. Storia di malattia cronica del sistema immunitario diversa dalla SM o nota sindrome da immunodeficienza 2. Storia o presenza di tumore maligno (fatta eccezione per il carcinoma cutaneo baso- o squamo-cellulare trattato con successo) 3. Pazienti diabetici con retinopatia diabetica non proliferativa moderata o grave, o con retinopatia diabetica proliferativa, o pazienti con diabete non controllato con HbA1c &gt; 8% 4. Diagnosi di edema maculare (ai pazienti con storia di edema maculare sara' consentito di entrare nel programma purche' non presentino edema maculare alla prima visita) 5. Infezioni sistemiche batteriche, virali o micotiche in fase attiva, o diagnosi di AIDS, epatite B, epatite C definite come positivita' al test per gli anticorpi verso il virus HIV, per l’ antigene di superficie dell’epatite B o per gli anticorpi verso il virus dell’epatite C, rispettivamente 6. Pazienti che non presentino storia clinica di varicella e risultino negativi al test per gli anticorpi IgG verso il Virus Varicella-Zoster (VZV) alla prima visita (per questi pazienti si puo' prendere in considerazione la vaccinazione VZV, e potranno essere inclusi ≥ 1 mese dopo la vaccinazione) 7. Pazienti che abbiano ricevuto vaccini vivi o vivi attenuati (compresi quelli per Virus Varicella-Zoster o morbillo) nel mese precedente la prima visita 8. Pazienti che abbiano ricevuto irradiazione linfonodale totale o trapianto di midollo osseo 9. Pazienti che siano stati trattati con: • Corticosteroidi o ormone adrenocorticotropo (ACTH) nel mese precedente la prima visita • farmaci immunosoppressori quali azatioprina o metotrexate nei 6 mesi precedenti la prima visita • Immunoglobuline e/o anticorpi monoclonali (compreso natalizumab) nei 3 mesi precedenti l’inclusione • cladribina, ciclofosfamide o mitoxantrone in qualsiasi momento 10. Una qualsiasi delle seguenti patologie cardiovascolari: • Insufficienza cardiaca al momento della prima visita (Classe III, secondo la classificazione NYHA) o qualsiasi patologia cardiaca grave, secondo valutazione del medico • Frequenza cardiaca a riposo &lt; 45 bpm al momento della prima visita • Infarto miocardico nei 6 mesi precedenti • Storia o presenza di blocco AV di terzo grado • Storia di blocco AV di secondo grado tipo II secondo Mobitz • Storia clinica confermata di sindrome del seno malato o blocco cardiaco seno-atriale • Aritmia in trattamento attuale con farmaci antiaritmici di classe Ia (ajmalina, disopiramide, procainamide, chinidina) o di classe III (p.es. amiodarone, bretilio, sotalolo, ibutilide, zimilide, dofetilide) • Ipertensione non controllata dai farmaci 11. Una qualsiasi delle seguenti patologie polmonari: • malattia respiratoria severa o fibrosi polmonare • asma non controllata 12. Donne in gravidanza o che allattano al seno; si definisce gravidanza la condizione di una donna dopo il concepimento e fino al termine della gestazione, confermata da esame di laboratorio con positivita' di hCG (&gt; 5 mIU/mL) 13. Una qualsiasi delle seguenti patologie epatiche: • Nota storia di abuso di alcol, malattia epatica o biliare cronica, grave insufficienza epatica (classe C secondo Child-Pugh) • Bilirubina totale oltre il limite superiore della norma, a meno che non sia nel contesto di una sindrome di Gilbert • Bilirubina coniugata oltre il limite superiore della norma • Fosfatasi alcalina piu' di 1,5 volte oltre il limite superiore della norma • Valori di AST (SGOT) e ALT (SGPT) piu' alti di 2 volte oltre il limite superiore della norma e/o gamma-glutamil-transferasi (GGT) piu' alti di 3 volte oltre il limite superiore della norma
    E.5 End points
    E.5.1Primary end point(s)
    The objective of this study is to provide early access to fingolimod to patients who have been diagnosed with relapsing-remitting multiple sclerosis for whom no suitable therapy exists (i.e. where existing therapies have failed) and to generate additional safety and tolerability data, according to the label recommended by CHMP, in a population resembling that of future clinical practice. For this reason, data analysis will simply be descriptive. No sample size calculation was performed. It is expected that approximately 600 patients will be enrolled during the planned duration of the trial. The actual number of enrolled patients may therefore differ from the planned one, based on the actual accrual rate in the various participating sites.
    L’obiettivo di questo studio e' di offrire un accesso allargato al trattamento con fingolimod ai pazienti in cui sia stata fatta una diagnosi di sclerosi multipla recidivante-remittente e per i quali non vi sia terapia idonea (cioe' quando le terapie esistenti hanno fallito) e generare dati di sicurezza e tollerabilita' aggiuntivi, seguendo le indicazioni approvate dal CHMP, in una popolazione che assomiglia a quella identificabile nella futura pratica clinica. Per questo motivo, le analisi effettuate sui dati saranno semplicemente di tipo descrittivo. Non e' stato effettuato il calcolo della dimensione campionaria, ma e' previsto che circa 600 pazienti saranno arruolati nel corso dello studio. Il numero dei pazienti arruolati potra' quindi differire dal numero inizialmente pianificato, sulla base dell’effettiva frequenza di arruolamento nei centri che partecipano allo studio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    offrire un accesso allargato al trattamento con fingolimod ai pazienti in cui sia stata fatta una di
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 concerned89
    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
    Lo studio iniziera' in ogni centro dopo l’ottenimento delle relative autorizzazioni etico-amministrative e terminera' nel momento in cui il farmaco del commercio sara' disponibile per i pazienti afferenti al centro.
    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 months17
    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 months17
    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 Information not present in EudraCT
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-09-01. Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    • Paz. per i quali non esista un trattamento adeguato,dove le ter. alternative hanno fallito
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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 Decision2011-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
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