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    Summary
    EudraCT Number:2007-001162-32
    Sponsor's Protocol Code Number:CAMMS32400507
    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:2008-07-14
    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 number2007-001162-32
    A.3Full title of the trial
    A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy
    Studio randomizzato di Fase 3, con valutatore e dose in cieco, di confronto tra due diversi dosaggi di Alemtuzumab somministrato per via endovenosa annualmente e tre iniezioni sottocutanee settimanali di Interferone beta-1a (Rebif) in pazienti con sclerosi multipla recidivante-remittente che abbiano presentato una recidiva durante il trattamento con immunomodulanti
    A.3.2Name or abbreviated title of the trial where available
    CARE MS-II
    CARE MS-II
    A.4.1Sponsor's protocol code numberCAMMS32400507
    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 SponsorGenzyme Corporation
    B.1.3.4CountryUnited States
    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 MABCAMPATH
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    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 INNAlemtuzumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number10
    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 typeNon Applicabile
    D.IMP: 2
    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 REBIF
    D.2.1.1.2Name of the Marketing Authorisation holderIND.FARMACEUTICA SERONO 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNInterferon beta-1a
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number44
    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 typeNon Applicabile
    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
    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 10048393
    E.1.2Term Multiple sclerosis relapse
    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 this study are to compare the safety and efficacy of 2 annual cycles of either 12 mg/day or 24 mg/day intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta-1a (Rebif) in patients with active relapsing-remitting multiple sclerosis (RRMS) who have experienced at least 1 relapse during prior treatment with an interferon beta or glatiramer acetate, after having received that therapy for &#8805; 6 months.
    Gli obiettivi di questo studio sono confrontare la sicurezza e l`efficacia di 2 cicli annuali di dosi endovenose (IV) da 12 mg/die o da 24 mg/die di alemtuzumab con 3 iniezioni sottocutanee (SC) settimanali di interferone beta-1a (Rebif) in pazienti con sclerosi multipla recidivante-remittente (RRMS) attiva in cui si e` evidenziata almeno 1 recidiva durante il precedente trattamento con interferone beta-1a o glatiramer acetato, dopo aver ricevuto tale terapia per &#8805; 6 mesi.
    E.2.2Secondary objectives of the trial
    • Proportion of patients who are relapse free at Year 2. • Change from baseline in EDSS. • Acquisition of disability as measured by change from baseline in MSFC. • Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2.
    • Proporzione dei pazienti senza recidive al secondo anno.• Cambiamento nel punteggio EDSS dalla visita di baseline.• Acquisizione della disabilita` misurata come cambiamenti dalla visita di baseline nella MSFC.• Cambiamento in percentuale dalla visita di baseline nel volume della lesione iperintensa T2 MRI al secondo anno
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:2 A1
    Date:2008/07/03
    Title:
    Objectives:



    FARMACOCINETICA/FARMACODINAMICA:
    Vers:2 A1
    Data:2008/07/03
    Titolo:sottostudio di farmacocinetica
    Obiettivi:si veda protocollo 9.1.1.4

    ALTRI SOTTOSTUDI:
    (inclusi nel protocollo) e condotti in centri selezionati o su sottopopolazioni: 1- di laboratorio 2-del seme (analisi conta spermatica e mobilita`, anticorpi)3- imaging

    E.3Principal inclusion criteria
    1- Signed informed consent form (ICF) 2- Age 18 to 55 years old (inclusive) as of the date the ICF is signed 3- Diagnosis of MS per update of McDonald criteria 4- Onset of MS symptoms (as determined by a neurologist, at present or retrospectively) within 10 years of the date the ICF is signed 5- EDSS score 0.0 to 5.0 (inclusive) at Screening 6- &#8805;2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF is signed, with &#8805;1 attack in the 12 months prior to the date the ICF is signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider. The objective signs may be identified retrospectively. 7- &#8805;1 MS attack (relapse) during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for &#8805;6 months within 10 years of the date the ICF is signed 8- Neurologically stable for the 30 days prior to the date the ICF is signed (eg, no relapse) 9- MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist o &#8805;9 T2 lesions at least 3 mm in any axis o a gadolinium-enhancing lesion at least 3 mm in any axis plus &#8805;1 brain T2 lesions o a spinal cord lesion consistent with MS plus &#8805;1 brain T2 lesions
    1- Modulo di consenso informato (ICF) firmato. 2- Eta` compresa tra 18 e 55 anni (inclusi), alla data della firma del modulo ICF. 3- Diagnosi di SM in accordo ai criteri di McDonald aggiornati. 4- Comparsa dei sintomi della SM (determinata da un neurologo, attualmente o retrospettivamente) nei 10 anni precedenti la data della firma del modulo ICF. 5- Punteggio EDSS compreso tra 0.0 e 5.0 (inclusi) allo screening. 6- &#8805;2 attacchi di SM (primo episodio o recidiva) occorsi nei 24 mesi precedenti la data della firma del modulo ICF, con &#8805;1 attacco nei 12 mesi precedenti la data della firma del modulo ICF, con segni neurologici oggettivi confermati da un medico, un infermiere specializzato o un altro operatore sanitario approvato da Genzyme. I segni oggettivi possono essere identificati retrospettivamente. 7- &#8805;1 attacco di SM (recidiva) durante il trattamento con interferone beta o glatiramer acetato dopo essere stato in tale terapia per &#8805;6 mesi nei 10 anni precedenti la data della firma del modulo ICF. 8- Stabilita` neurologica nei 30 giorni precedenti la data della firma del modulo ICF (nessuna recidiva). 9- Scansione MRI che dimostra la presenza di lesioni della sostanza bianca attribuibili alla SM e rispetto di almeno 1 dei seguenti criteri, determinato dal neurologo o dal radiologo: o &#8805;9 lesioni T2 di almeno 3 mm in qualunque asse; o una lesione captante il gadolinio di almeno 3 mm in qualunque asse piu` &#8805;1 lesioni cerebrali T2; o una lesione del midollo spinale coerente con la SM piu` &#8805;1 lesioni cerebrali T2.
    E.4Principal exclusion criteria
    •Previous treatment with alemtuzumab • Current participation in another clinical study or previous participation in CAMMS323 • Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Patients who received one of these medications more than 6 months before the date the ICF is signed may be eligible for study entry if approval is granted by Genzyme •Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) •Previous treatment with any investigational medication, ie drug has not been approved at any dose or for any indication. (Prior treatment with herbal medications or nutritional supplements is permitted) •Any progressive form of MS •History of malignancy, except basal skin cell carcinoma •Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS and return to within normal limits after washout • Previous hypersensitivity reaction to any immunoglobulin product • Known allergy or intolerance to interferon beta, human albumin, or mannitol • Intolerance of pulsed corticosteroids, especially a history of steroid psychosis • Inability to self-administer SC injections or receive SC injections from caregiver • Inability to undergo MRI with gadolinium administration • Confirmed platelet, CD4+, CD8+, B-cell, absolute neutrophil count <LLN at Screening (see protocol) • Known bleeding disorder (see protocol) • Seropositivity for human immunodeficiency virus (HIV) • Significant autoimmune disease (see protocol)• Presence of anti thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (ie, above LLN) • Active infection, (see protocol) • In the Investigator's opinion, is at high risk for infection (see protocol) • Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis (see Study Operations Manual (SOM)) • Infection with hepatitis C virus • Past or present hepatitis B infection (positive hepatitis B serology) • Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating • Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period (see protocol) • Epileptic seizures that are not adequately controlled by treatment • Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results (see protocol)• Medical, psychiatric (not adequately controlled by treatment), cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study • Prior history of invasive fungal infections • Cervical high risk human papillomavirus (HPV) positivity or abnormal cervical cytology (see protocol) • Seropositive for Trypansoma cruzi or the human T-lymphotropic virus type I or type II (HTLV-I/II) (testing required in endemic regions only). Guidance on region-specific testing recommendations and patient eligibility is provided in the SOM • Any other illness or infection could be exacerbated by either study medication (see protocol) • Any hepatic or renal function value grade 2 or higher at Screening, with the exception of hyperbilirubinemia due to Gilbert's syndrome (see protocol)
    •Precedente trattamento con alemtuzumab •Partecipazione concomitante a un altro studio clinico o precedente partecipazione a CAMMS323 •Trattamento con natalizumab, metotrexato, azatioprina o ciclosporina negli ultimi 6 mesi.I pazienti che hanno ricevuto uno di questi farmaci oltre 6 mesi prima della data della firma del modulo ICF potranno essere considerato idonei per questo studio, nel caso in cui Genzyme conceda l`approvazione.•Precedente trattamento con mitoxantrone, ciclofosfamide, cladribina, rituximab o qualunque altra terapia con immunosoppressori o citotossici (diversi dagli steroidi) •Precedente trattamento con farmaci sperimentali, ovvero farmaci che non sono stati approvati in qualunque dosaggio o per qualunque indicazione.(E` ammesso un precedente trattamento con erbe mediche o integratori nutrizionali) •Qualunque forma progressiva di SM • Storia di neoplasie, ad eccezione del carcinoma a cellule basali della pelle •Ogni disabilita` dovuta a traumi o ad altre malattie che, secondo il parere dello Sperimentatore, possa interferire con la valutazione della disabilita` dovuta alla SM •Precedente reazione di ipersensibilita` a prodotti contenenti immunoglobulina •Allergia o intolleranza conosciuta all`interferone beta, all`albumina umana o al mannitolo •Intolleranza a terapie corticosteroidi non continuative, in particolare storia di psicosi steroidea •Impossibilita` a praticarsi iniezioni SC o a ricevere iniezioni SC praticate dal personale curante •Impossibilita` a sottoporsi a una MRI con somministrazione di gadolinio •Conteggio piastrine, CD4+, CD8+, conteggio ssoluto neutrofili &#61500;LLN allo screening (rif.protocollo) •Disturbo emorragico conosciuto (rif.protocollo) •Sieropositivita` al virus dell`immunodeficienza umana (HIV) •Malattia autoimmune significativa(rif.protocollo) •Presenza di anticorpi anti recettore (TSHR) dell`ormone tireotropo (TSH) (i.e.sopra il limite LLN) •Infezione attiva (rif.protocollo) •Secondo il parere dello Sperimentatore, alto rischio di infezione (rif.protocollo) •Tubercolosi latente, a meno di aver completato una terapia anti-tubercolotica efficace, o tubercolosi attiva (di veda lo Study Operations Manual (SOM)) •Infezione da virus dell`epatite C •Infezione passata o presente da epatite B (sierologia positiva all`epatite B) •Donna in eta` fertile con test di gravidanza su siero positivo, in gravidanza o in allattamento •Rifiuto di utilizzare un metodo contraccettivo adeguato e affidabile per l`intera durata dello studio(rif.protocollo) •Attacchi epilettici non adeguatamente controllati da un trattamento •Grave disturbo sistemico o altra malattia che, secondo il parere dello Sperimentatore, potrebbe compromettere la sicurezza del paziente o interferire con l`interpretazione dei risultati dello studio (rif.protocollo) •Condizioni mediche, psichiatriche (non adeguatamente controllate da trattamento), cognitive o di altro tipo che, secondo il parere dello Sperimentatore, compromettono la capacita` del paziente di comprendere le informazioni a lui destinate, fornire il consenso informato, rispettare il protocollo di sperimentazione o completare lo studio •Storia precedente di infezioni micotiche invasive •Positivita` cervicale ad alto rischio al papillomavirus umano (HPV), oppure citologia cervicale anormale(rif.protocollo) •Sieropositivita` al Trypanosoma cruzi o al virus umano T-linfotropico di tipo I o II (HTLV-I/II) (test richiesto nelle sole regioni endemiche).Le linee guida sulle raccomandazioni di esaminazione e sull`idoneita` dei pazienti relative a una regione specifica sono contenute nel manuale SOM •Ogni altra malattia o infezione che potrebbe aggravarsi a causa di un qualunque farmaco dello studio (rif.protocollo) •Qualunque valore della funzionalita` epatica o renale di grado 2 o superiore allo screening, con l`eccezione della iperbilirubinemia dovuta alla sindrome di Gilbert (rif.protocollo)
    E.5 End points
    E.5.1Primary end point(s)
    The study will be considered to have met its efficacy objectives if a statistically significant treatment effect between alemtuzumab and SC interferon beta-1a groups is observed from time to SAD or relapse rate.
    Lo studio avra` raggiunto i propri obiettivi di efficacia se sara` osservato un effetto terapeutico statisticamente significativo di alemtuzumab rispetto a interferone beta-1a SC rispetto alla tempistica SAD o al tasso di recidiva.
    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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    dose in cieco (12 vs.24 mg). Valutatore in cieco.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA125
    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
    Per ogni paziente 2 anni dopo l`inizio della terapia al mese 0, pertanto la fined dello studio sara` a due anni dopo l`inizio della terapia al mese 0 dell`ultimo paziente.
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 2008-07-14. 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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 573
    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)
    I trattamenti post studio saranno i normali trattamenti previsti dalla normale pratica clinica. comunque tutti i pazienti saranno invitati a partecipare ad un protocollo di estensione per il follow up a lungo termine che includera` il monitoraggio della sicurezza per almeno 3 anni dall`ultimo trattamento con alemtuzumab.Anche i pazienti trattati con con interferone beta1a che avranno completato i due anni di studio avranno l`oppotunita` di partecipare all`estensione ricevendo alemtuzumab.
    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 Decision2008-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-15
    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
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