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    Summary
    EudraCT Number:2010-019395-73
    Sponsor's Protocol Code Number:CPJMR0012201
    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:2012-02-28
    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 number2010-019395-73
    A.3Full title of the trial
    A 2-week single-blind, randomized, 3-arm proof of concept study of the effects of AIN457 (anti-IL17 antibody), ACZ885 (canakinumab, anti-IL1b antibody), or corticosteroids in patients with polymyalgia rheumatica, followed by an open label phase to assess safety and long term efficacy
    Studio proof of concept a 3 bracci, randomizzato, in singolo cieco, della durata di 2 settimane, per dimostrare gli effetti di AIN457 (anticorpo anti IL-17), ACZ885 (canakinumab, anticorpo anti IL-1β) o corticosteroidi in pazienti affetti da polimialgia reumatica, seguito da una fase in aperto per valutare la sicurezza e l efficacia a lungo termine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 2-week study in patients with polymyalgia rheumatica
    studio di 2 settimane nei pazienti con polimialgia reumatica
    A.4.1Sponsor's protocol code numberCPJMR0012201
    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 Pharma
    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 (VA)
    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 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 nameNA
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNSecukinumab
    D.3.9.2Current sponsor codeAIN457A
    D.3.9.3Other descriptive namerhumAb to Il-17A (IgG1-k-class)
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human monoclonal antibody to Interleukin-17A of the IgG1/kappa-class
    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 ILARIS*SC 1FL 150MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/439
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNCANAKINUMAB
    D.3.9.1CAS number 914613-48-2
    D.3.9.2Current sponsor codeACZ885
    D.3.9.3Other descriptive nameRecombinant human monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Yes
    D.3.11.13.1Other medicinal product typeFully human monoclonal antibody produced in mouse hybridoma Sp2/0 cells by recombinant DNA technolog
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednison Hexal
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    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 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 INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboTablet
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polymyalgia rheumatica
    Polimialgia reumatica
    E.1.1.1Medical condition in easily understood language
    Polymyalgia rheumatica
    Polimialgia reumatica
    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 PT
    E.1.2Classification code 10036099
    E.1.2Term Polymyalgia rheumatica
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 assess the efficacy of a single dose of AIN457 after 2 weeks as measured by the polymyalgia rheumatica activity score; - To assess the efficacy of a single dose of ACZ885 (canakinumab) after 2 weeks as measured by the polymyalgia rheumatica activity score.
    • Valutare l`€™efficacia di una singola somministrazione di AIN457 a 2 settimane attraverso il punteggio totale di attivita' della polimialgia reumatica • Valutare l`€™efficacia di una singola somministrazione di ACZ885 a 2 settimane attraverso il punteggio totale di attivita' della polimialgia reumatica
    E.2.2Secondary objectives of the trial
    - To assess the time to partial clinical response, time to complete response and time to first flare in patients who respond to a single dose of AIN457 or ACZ885 (canakinumab); - To assess the effect of AIN457 and ACZ885 on the number of flares over a 6 month period; - To assess the effect of AIN457 and ACZ885 on the cumulative and/or mean steroid dose over a 6 month period; - To assess the safety and tolerability of AIN457 and ACZ885 in patients with polymyalgia rheumatic; - To characterize the PKs of AIN457 and ACZ885 in patients with polymyalgia rheumatic; - To compare the initial response to AIN457 and ACZ885 with the response after redosing of AIN457 and ACZ885; - To assess the effect on health-related quality of life (HAQ, SF-36); - To assess the potential for immunogenicity induced by ACZ885 / AIN457 in PMR patients.
    • Valutare il tempo alla risposta clinica parziale, alla risposta clinica completa ed il tempo alla prima recidiva in pazienti con risposta positiva ad una singola dose di AIN457 o ACZ885 • Valutare l`€™effetto di AIN457 e ACZ885 sul numero di recidive a 6 mesi • Valutare l`€™effetto di AIN457 e ACZ885 sulla dose cumulativa e/o media di steroidi a 6 mesi • Valutare il profilo di sicurezza e tollerabilita' nei pazienti con polimialgia reumatica in trattamento con AIN457 o ACZ885 • Caratterizzare il profilo di farmacocinetica di AIN457 o ACZ885 nei pazienti con polimialgia reumatica • Comparare la risposta iniziale ad AIN457 o ACZ885 rispetto al ritrattamento successivo con AIN457 o ACZ885 • Valutare l`€™effetto sulla qualita' della vita legata alla salute (HAQ, SF-36) • Valutare il potenziale immunogenico di AIN457 o ACZ885nei pazienti con polimialgia reumatica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be aged `‰¥50 and `‰¤85 at time of consent. 2. Patients with newly diagnosed PMR as well as patients with a history of PMR or previous PMR episodes treated with corticosteroids. Corticosteroid treatment must not have been within 3 months of the screening visit. 3. All female subjects must have negative pregnancy test results at screening (serum) and baseline (urine). Women of childbearing potential (WoCBP) must be using simultaneously doublebarrier or two acceptable methods of contraception, (e.g. intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc., hormonal contraception as either oral or implantable is acceptable as one form), from the time of screening and for the duration of the study, through study completion and for 4 months following study completion and for 6 months post last dose of AIN457 / ACZ885 (canakinumab). Women on hormone contraception should be on this regimen for at least 2 months prior to study start. Postmenopausal females must have had no regular bleeding for at least two (2) years prior to initial dosing. If menopause is confirmed by a plasma FSH level of <40 IU/L at screening, pregnancy test will only be required at screening or consistent with menopause per local laboratory, pregnancy tests will be required before each infusion. Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and/or Principle Investigator and noted in the Relevant Medical History / Current Medical Conditions section in the eCRF. If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than six (6) months prior to first dosing. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 4. Male subjects must be using two highly effective methods of contraception, comprising a barrier method condom or occlusive cap plus spermicide) plus ensure use by the female partner of a second method of contraception. These measures should be in place for the entire duration of the study up the Study Completion visit, and males should refrain from fathering a child in at least 6 months post last dose of AIN457/ACZ885 (canakinumab) 5. Patients must meet all of the following criteria (based on BSR guideline on PMR): • Age `‰¥ 50 and `‰¤85 years • CRP > 1.0 mg/dl OR ESR > 30 mm/hr • New bilateral shoulder and/or hip pain • Early Morning stiffness `‰¥ 60 min (at least 60 minutes) • Duration of illness > 1 week (at the time of initial diagnosis) 6. Patient must be able to understand and communicate with the investigator, to understand and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed. 7. All patients receiving current vaccinations, especially influenza and pneumococcal as clinically indicated can be included. Patients should not receive any live vaccines (this includes nasal-spray flu vaccine) within 12 weeks before study entry and within 12 weeks of the last dose of AIN457 or ACZ885 (canakinumab). 8. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 17 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
    • Pazienti con nuova diagnosi di PMR o pazienti con anamnesi positiva per PMR o pazienti con precedenti episodi ascrivibili a PMR trattati con corticosteroidi. Il trattamento con corticosteroidi non deve essere avvenuto nei 3 mesi precedenti alla visita di screening • Pazienti di eta' compresa tra 50 e 85 anni (estremi inclusi) con o PCR `‰¥ 1.0 mg/L oppure o VES `‰¥ 30 mm/h o Dolore bilaterale di nuova insorgenza alle spalle e/o anche o Rigidita' mattutina di durata uguale o superiore a 60 min o Durata della malattia superiore ad 1 settimana • Test PPD 5 U o QuantiFERON negativo allo screening (`‰¤5 mm di indurazione)
    E.4Principal exclusion criteria
    - 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); - Men who are planning to initiate a pregnancy while enrolled in the study or for 4 months following completion of the study, or who are not willing to follow the restrictions in inclusion criterion 3. Male or female patients who plan to conceive during the time course of the study and 6 months post last infusion of AIN457/ACZ885 (canakinumab); - Presence of rheumatoid arthritis or other inflammatory arthritic processes (features of GCA (Giant Cell Arthrtitis), spondyloarthropathies, Osteoarthritis, symptomatic shoulder capsulitis), connective tissue disease, drug-induced myopathies, chronic pain syndromes, as assessed by base line screening including TSH, CK, RF, CCP, ANA, serum protein electrophoresis, urinalysis; - History of PMR and Previous PMR episodes treated with steroids; - Previous exposure to methotrexate or other immune suppressive agent within 3 months prior to randomization; - Previous exposure to AIN457 or ACZ885 (canakinumab) or other biologic targeting IL-17, IL-17 receptor, IL-1b or IL-1β receptor, or use of any investigational drug and/or devices within 4 weeks prior to randomization or 5 half-lives of the investigational agent, whichever is longer and for any other limitation of pariticipation based on local regulations; - Active systemic infections during the last two weeks (exception: common cold) prior to randomization or current use of antibiotics.
    • Evidenza di infezioni attive o uso corrente di antibiotici • Anamnesi positiva per infezioni da HIV, HCV o HBV • Trattamento pregresso con MTX o altre terapie immunosoppressive durante i 3 mesi precedenti alla visita basale • Anamnesi positiva per neoplasie durante i 5 anni precedenti l`€™entrata in studio, ad eccezione di carcinoma a cellule squamose o basali non metastatico trattato con successo, e/o carcinoma localizzato in situ della cervice uterina • Evidenza allo screening (e confermato dal reperto laboratoristico sulla base di TSH, CK, FR, CCP, ANA, elettroforesi delle proteine, analisi delle urine) di artrite reumatoide o altri processi artritici infiammatori, malattie del connettivo, miopatie indotte da farmaco, disordini endocrini o neurologici, sindromi da dolore cronico Per maggiori dettagli consultare i paragrafi 5.1 e 5.2 del protocollo originale.
    E.5 End points
    E.5.1Primary end point(s)
    PMR-AS on Day 15
    PMR-AS al giorno 15
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15
    Giorno 15
    E.5.2Secondary end point(s)
    Secondary End Point - To assess the time to partial clinical response, time to complete response and time to first flare in patients who respond to a single dose of AIN457 or ACZ885 (canakinumab) using the PMR activity score. - To assess the effect of AIN457 and ACZ885 (canakinumab) on the number of flares over a 6 month period using the PMR activity score at 6 month timepoint. - To assess the effect of AIN457 and ACZ885 (canakinumab) on the cumulative and/or mean steroid dose over a 6 month period comparing the steroid use due to flares in patients after 6 months. - To assess the safety and tolerability of AIN457 and ACZ885 (canakinumab) in patients with polymyalgia rheumatica by monitoring different standard lab parameters throughout the study period and collecting information on adverse events including infections from these patients. - To characterize the PKs of AIN457 and ACZ885 (canakinumab) in patients with polymyalgia rheumatica measured in blood serum samples. - To compare the initial response to AIN457 and ACZ885 (canakinumab) with the response after re-dosing of AIN457 and ACZ885 (canakinumab) using the PMR activity scores measured at these timepoints. - To assess the effect on health-related quality of life (HAQ, SF-36) by completion of respective patient reported outcome questionnaires. - To assess the potential for immunogenicity induced by ACZ885 (canakinumab) / AIN457 in PMR patients measured in blood serum samples.
    • Valutare il tempo alla risposta clinica parziale, alla risposta clinica completa ed il tempo alla prima recidiva in pazienti con risposta positiva ad una singola dose di AIN457 o ACZ885 • Valutare l`€™effetto di AIN457 e ACZ885 sul numero di recidive a 6 mesi • Valutare l`€™effetto di AIN457 e ACZ885 sulla dose cumulativa e/o media di steroidi a 6 mesi • Valutare il profilo di sicurezza e tollerabilita' nei pazienti con polimialgia reumatica in trattamento con AIN457 o ACZ885 • Caratterizzare il profilo di farmacocinetica di AIN457 o ACZ885 nei pazienti con polimialgia reumatica • Comparare la risposta iniziale ad AIN457 o ACZ885 rispetto al ritrattamento successivo con AIN457 o ACZ885 • Valutare l`€™effetto sulla qualita' della vita legata alla salute (HAQ, SF-36) • Valutare il potenziale immunogenico di AIN457 o ACZ885nei pazienti con polimialgia reumatica
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described in the Secondary end point.
    Come descritto nell'End point secondario.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicita'
    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 Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    United States
    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 : 18/APR/2012
    LVLS : 18/04//2012
    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 months7
    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 months14
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 35
    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)
    Based on the evidence of efficacy and safety will be planning a further clinical development plan for perpetrating the best treatment for the cure of the disease in question.
    Sulla base delle evidenze di efficacia e sicurezza sarà pianificato un ulteriore piano di sviluppo clinico atto a perpetrare il trattamento migliore per la cura della patologia in oggetto.
    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 Decision2011-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-01-29
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