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   41232   clinical trials with a EudraCT protocol, of which   6757   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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:2005-001009-25
    Sponsor's Protocol Code Number:DR04-07-02
    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:2006-03-15
    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 number2005-001009-25
    A.3Full title of the trial
    Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA.
    Efficacia, sicurezza e tollerabilita` dell`Atorvastatina 40 mg in pazienti con sclerosi multipla recidivante remittente in trattamento con Interferone beta. (ARIANNA)
    A.3.2Name or abbreviated title of the trial where available
    ARIANNA
    ARIANNA
    A.4.1Sponsor's protocol code numberDR04-07-02
    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 SponsorDR DIMENSIONE RICERCA
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 TORVAST*10CPR 10MG
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    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 Film-coated tablet
    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 INNAtorvastatin
    D.3.9.1CAS number 134523-03-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number40
    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 TORVAST*10CPR 10MG
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    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 Film-coated tablet
    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 INNAtorvastatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Multiple sclerosis treatment
    Trattamento della sclerosi multipla
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint of the study is the efficacy of Atorvastatin compared to placebo, in patients RRMS already in treatment with Interferon-beta, evaluating the disease activity measured by the changes in brain atrophy after 24 months of treatment.
    Efficacia dell Atorvastatina, in confronto al placebo, somministrata in pazienti con sclerosi multipla recidivante-remittente (SMRR) gia` in trattamento con interferone beta, valutando l attivita` di malattia attraverso la misurazione del cambiamento dell atrofia cerebrale dopo 24 mesi di trattamento.
    E.2.2Secondary objectives of the trial
    1.Clinical disease progression (EDSS, MSFC)2.Functional systems subscores of EDSS and MSFC 3.Cognitive performance by Rao battery tests4.Proportion of patients relapse-free after 12 and 24 months of treatment5.Relapse rate after 12 and 24 months of treatment6. Hazard rate of relapses7.Time to first relapse 8. Number of T1 lesions for each patient after 12 and 24 months of treatment 9. Number of T2 lesions for each patient after12 and 24 months of treatment10. New T2 lesions after 24 months 11.Number of Gd-enhancing lesion on T1-weighted images after 12 and 24 months of treatment12. Volume changes of total T2 lesions after 12 and 24 months of treatment13.Volume changes of total T1 lesions after 12 and 24 monthsoftreatment 14.Proportion of patients without increase of total lesion volume after 12 and 24 months of treatment 15.Changes in brain volume,(atrophy after 12months, grey matter and white matterafter12and24 months)16.NAband MxAtitles17Serum lipid levels18.Correlationof APOE
    Progressione clinica della malattia(EDSS,MSFC)2.Sottopunteggi dei sistemi funzionali di EDSS e MSFC 3.Performance cognitiva4.Proporzione di paz liberi da ricadute dopo 12 e 24 mesi di tratt 5.Tasso di ricadute dopo 12 e 24 mesi di tratt 6.Tasso di rischio di ricaduta 7.T alla prima ricaduta 8.NR di lesioni T1 per ciascun paz dopo 12 e 24 mesi di tratt 9.Numero di lesioni T2 per ciascun paz dopo 12 e 24 mesi di tratt 10.Proporzione di paz con nuove lesioni in T2 dopo 24 mesi di tratt.11.NR di lesioni captanti gadolinio in immagini T1 pesate dopo 12 e 24 mesi di tratt 12.Variaz di volume di tutte le lesioni in T2 dopo 12 e 24 mesi di tratt 13.Variaz di volume di tutte le lesioni in T1 dopo 12 e 24 mesi di tratt 14.Proporzione di paz senza aumento del volume totale di lesioni dopo 12 e 24 mesi di tratt 15.Modificazioni del volume cerebrale(atrofia dopo 12 mesi,sostanza grigia e bianca dopo 12 e 24 mesi)16.Titolazioni di NAB e MxA 17.Livelli plasmatici dei lipidi
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI:
    1. Dosaggio delle proteine MxA 2. Dosaggio Apolipoproteina E

    E.3Principal inclusion criteria
    1. Patients with relapsing-remitting forms of Multiple Sclerosis (according to McDonald s criteria; 28) with disease duration > 3 months and - 5 years. 2. EDSS score between 1.0 and 5.5, inclusive. 3. Currently treated with, and tolerating, Interferon beta, and having received this treatment for more than 3 and less than 12 months. 4. Age between 18 and 50 years, inclusive. 5. Patients must agree to avoid macrolids, including erytromicine and claritromicine for the whole study duration. 6. A woman of child-bearing potential must agree to adapt the proper behaviour adequately to avoid pregnancy while on study. 7. Negative pregnancy test results at screening day (all women of childbearing potential only). 8. Consent to go on the diet (appendix 2). 9. Written informed consent. 10. Serum lipid profile, as defined in appendix 3. 11. Adequate bone marrow, renal, and hepatic function, as defined in appendix 4.
    1. Pazienti con SMRR (clinicamente definita sec. i criteri di McDonald) con durata della malattia &gt; 3 mesi e - 5 anni 2. EDSS compresa tra 1.0 e 5.5 incluso 3. Pazienti in trattamento, ben tollerato, con Interferone beta da almeno 3 mesi e non piu` di 12 4. Eta` compresa tra 18 e 50 anni compiuti 5. Pazienti disponibili ad evitare terapie con macrolidi, incluso eritromicina e claritromicina, per tutta la durata dello studio 6. Pazienti di sesso femminile in eta` fertile disponibili ad adattare il proprio comportamento per evitare di contrarre una gravidanza per tutta la durata dello studio 7. Test di gravidanza negativo al giorno della selezione (per le pazienti di sesso femminile in eta` fertile) 8. Consenso a seguire una dieta (appendice 2) 9. Consenso informato scritto 10. Profilo lipidico sierico come da valori riportati nell appendice 3 11. Funzione midollare, renale ed epatica adeguate come da valori riportati in appendice 4
    E.4Principal exclusion criteria
    1. Any disease other than Multiple Sclerosis that would better explain the patient s signs and symptoms. 2. Primary progressive MS. 3. Secondary progressive MS. 4. Uncontrolled, clinically significant heart diseases, such as dysrhythmias, angina, or uncompensated congestive heart failure. 5. Previous confirmed venous thromboembolic disease including deep vein phlebitis and/or pulmonary embolism or known hemostatic disorder predisposing to thromboembolic complications. 6. Uncontrolled Seizure disorder. 7. Myopathy or clinically significant liver disease. 8. Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study. 9. Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study. 10. Well-known hypersensitivity to either Atorvastatin or Interferon &#946; or other human proteins including albumin.11. Well-known hypersensitivity to gadolinium. 12. Inability to undergo a MRI scan. 13. A relapse started within 30 days prior to screening or between screening and baseline. 14. A history of substance abuse (hard and soft drugs, alcoholic drinks) in the 90 days prior to screening. 15. Previous (at any time ) therapy with any of the following: monoclonal antibodies, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocoticotropic hormone; ACTH), total lymphoid irradiation. 16. Previous therapy, administrated for &#8805;12 months, with other interferon beta drugs, Mitoxantrone, Azathioprine or Glatiramer acetate in the 12 months before start of the currently interferon beta treatment.. 17. Previous treatment (at any time) with statins. 18. Treatment with any of the following in the 30 days before baseline: systemic corticosteroids, ACTH, or other investigational drugs.
    1. Qualunque malattia, oltre alla sclerosi multipla, che potrebbe meglio spiegare i segni ed i sintomi riferiti dal paziente 2. Sclerosi Multipla primariamente progressiva 3. Sclerosi Multipla secondariamente progressiva 4. Patologie cardiache, non controllate, clinicamente significative, come aritmie, angina o insufficienza cardiaca congestizia scompensata 5. Malattia venosa tromboembolica precedentemente confermata inclusa la flebite venosa profonda, e/o l embolia polmonare o disordini noti dell emostasi predisponenti a complicazioni tromboemboliche. 6. Epilessia non controllata 7. Miopatia o patologia epatica clinicamente significativa 8. Condizioni mediche o psichiatriche che possano compromettere la capacita` di sottoscrivere il consenso informato, rispettare il protocollo o completare lo studio 9. Impossibilita`, secondo l opinione dello sperimentatore o di un membro dello staff, di rispettare le richieste del protocollo per tutta la durata dello studio 10. Ipersensibilita` nota all Atorvastatina o all Interferone beta o ad altre proteine inclusa l albumina 11. Ipersensibilita` nota al Gadolinio 12. Impossibilita` ad eseguire la Risonanza magnetica 13. Una ricaduta che sia iniziata nei 30 gg prima dello screening o nell intervallo tra giorno della selezione e la visita del giorno 1 14. Storia di tossicodipendenza ( droghe pesanti o leggere ed alcol) nei 90 giorni precedenti giorno della selezione 15. Precedente terapia con: Anticorpi monoclonali e/o farmaci citotossici o immunosoppressivi (escluso corticosteroidi ormone adenocorticotropo e ACTH); radioterapia 16. Nei 12 mesi precedenti l inizio della terapia corrente con interferone beta terapia con Mitoxantrone, Azatioprina o Glatiramer acetato per 12 mesi o piu` 17. Precedente trattamento (in qualunque momento) con statine 18. Trattamento nei 30 giorni precedenti la visita del giorno 1 con corticosteroidi, ACTH o altri farmaci sperimentali
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint variable will be the changes in brain atrophy by brain MRI after 24 months.
    La variabile obiettivo primario sara` la misurazione del cambiamento dell atrofia cerebrale rivelata dalla risonanza magnetica dopo 24 mesi di trattamento.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned44
    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
    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 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.1.3Elderly (>=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 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 2006-03-15. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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 Decision2005-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA