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    Summary
    EudraCT Number:2020-005448-48
    Sponsor's Protocol Code Number:CN42097
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-17
    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 number2020-005448-48
    A.3Full title of the trial
    A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS
    STUDIO DI FASE III DI NON-INFERIORITÀ, RANDOMIZZATO, IN APERTO, A GRUPPI PARALLELI E MULTICENTRICO PER VALUTARE LA FARMACOCINETICA, LA FARMACODINAMICA, LA SICUREZZA E GLI EFFETTI RADIOLOGICI E CLINICI DI OCRELIZUMAB PER VIA SOTTOCUTANEA VERSUS OCRELIZUMAB PER VIA ENDOVENOSA IN PAZIENTI CON SCLEROSI MULTIPLA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis
    Questo studio valuterà farmacocinetica, farmacodinamica, sicurezza, immunogenicità ed effetti radiologici e clinici della somministrazione per via sottocutanea (s.c.) rispetto alla somministrazione per via endovenosa (e.v.) di ocrelizumab in pazienti con sclerosi multipla
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberCN42097
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffman-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0000000
    B.5.5Fax number000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ocrevus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameocrelizumab
    D.3.2Product code [RO4964913]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNOcrelizumab
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 typehumanized monoclonal antibody
    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 Ocrevus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameocrelizumab
    D.3.2Product code [RO4964913]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNOcrelizumab
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 typehumanized monoclonal antibody
    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
    Multiple Sclerosis (MS)
    Sclerosi Multipla (SM)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis is a long-term disease that attacks the central nervous system, affecting the brain, spinal cord, and optic nerves.
    La sclerosi multipla è una malattia a lungo termine che attacca il sistema nervoso centrale, interessando il cervello, il midollo spinale e i nervi ottici.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To demonstrate pharmacokinetics (PK) non-inferiority of the SC formulation of ocrelizumab in patients with MS
    • Dimostrare la non inferiorità in termini di farmacocinetica (PK) della formulazione SC di ocrelizumab in pazienti con SM
    E.2.2Secondary objectives of the trial
    • To determine the maximum serum concentration (Cmax) of ocrelizumab SC in patients with MS
    • To evaluate the radiological effects of ocrelizumab SC compared with ocrelizumab IV in patients with MS
    • To evaluate and compare the safety profile after administration of ocrelizumab SC versus ocrelizumab IV and to assess the safety of ocrelizumab SC at the selected dose in patients with MS
    • To evaluate the immune response to ocrelizumab SC and IV, and rHuPH0
    • To evaluate the effect of ocrelizumab SC compared with IV ocrelizumab on the pharmacodynamics (PD) marker for the mechanism of action of ocrelizumab (i.e. B cell depletion)
    • Stabilire la concentrazione sierica massima (Cmax) di ocrelizumab SC in pazienti con SM
    • Valutare gli effetti radiologici di ocrelizumab SC rispetto a ocrelizumab IV in pazienti con SM
    • Valutare e confrontare il profilo di sicurezza dopo somministrazione di ocrelizumab SC rispetto alla somministrazione di ocrelizumab IV e valutare la sicurezza di ocrelizumab SC alla dose prescelta in pazienti con SM
    • Valutare la risposta immunitaria a ocrelizumab SC e IV e rHuPH0
    • Valutare l’effetto di ocrelizumab s.c. rispetto a ocrelizumab e.v. sul marcatore PD del meccanismo d’azione di ocrelizumab (la deplezione delle cellule B)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of primary progressive multiple sclerosis (PPMS) or relapsing multiple sclerosis (RMS) according to the revised McDonald 2017 criteria
    • Age 18-65 years, inclusive, at time of signing Informed Consent Form
    • Ability to comply with the study protocol and schedule of protocol assessments, in the investigator's judgment
    • Expanded disability status scale (EDSS) score, 0-6.5, inclusive, at screening.
    • Neurological stability for >=30 days prior to both screening and baseline
    • Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score <2.0 at screening
    • Females of childbearing potential must agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months or 12 months (as applicable by the ocrelizumab [Ocrevus] local label) after the final dose of ocrelizumab
    • Female patients without reproductive potential may be enrolled if post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy)
    •Diagnosi di SMPP o SMR in base ai criteri di McDonald rivisti del 2017 (Thompson et al. 2018)
    •Età compresa tra 18 e 65 anni inclusi al momento della firma del modulo di consenso informato
    •Capacità, secondo il parere dello sperimentatore, di rispettare il protocollo dello studio e il programma di valutazioni del protocollo
    •Punteggio EDSS compreso tra 0 e 6,5 incluso allo screening
    •Stabilità neurologica da ¿ 30 giorni al momento dello screening e al basale
    •Durata della malattia dall’insorgenza dei sintomi di SM inferiore a 15 anni per i pazienti con punteggio EDSS 2,0 allo screening
    •Per le donne potenzialmente fertili consenso a praticare l’astinenza o a utilizzare metodi contraccettivi accettabili durante il periodo di trattamento e per 6 o 12 mesi (secondo le indicazioni locali approvate di ocrelizumab [Ocrevus]) dopo l’ultima dose di ocrelizumab
    •Pazienti di sesso femminile non potenzialmente fertili possono essere arruolate in post-menopausa a meno che la paziente non stia ricevendo una terapia ormonale per la sua menopausa o se chirurgicamente sterile (cioè isterectomia, ovariectomia bilaterale completa)
    E.4Principal exclusion criteria
    • Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening
    • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
    • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
    • Immunocompromised state
    • Receipt of a live attenuated vaccine within 6 weeks prior to randomization
    • Inability to complete an MRI or contraindication to gadolinium administration
    • Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines) for infusion-related reaction (IRRs), including closed angle glaucoma for antihistamines
    • Known presence of other neurologic disorders
    • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
    • Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study
    • History of or currently active primary or secondary (non-drug related) immunodeficiency
    • Pregnant or breastfeeding or intending to become pregnant during the study and 6 or 12 months (as applicable by the ocrelizumab [Ocrevus] local label) after last administration of the study drug.
    • Lack of peripheral venous access
    • History of alcohol or other drug abuse within 12 months prior to screening
    • Treatment with any investigational agent within 24 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS
    • Patients who have previously received anti-CD20s if the last treatment was less than 2 years before screening, and/or if B-cell count is below lower limit of normal, and/or the discontinuation of the treatment was due to safety reasons or lack of efficacy
    • Previous treatment with cladribine, atacicept, and alemtuzumab
    • Treatment with mitoxantrone within 2 years prior to baseline visit or evidence of cardiotoxicity following mitoxantrone use or a cumulative lifetime dose of more than 60 milligrams per meter square (mg/m^2)
    • Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label
    • If the washout requirements are not described in the applicable local label, then the wash out period must be 5 times the half-life of the medication. The PD effects of the previous medication must also be considered when determining the required time for washout
    • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
    • Any previous history of transplantation or anti-rejection therapy
    • Treatment with IV immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization
    • Systemic corticosteroid therapy within 4 weeks prior to screening
    • Positive screening tests for active, latent, or inadequately treated hepatitis B
    • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
    • Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above
    •Infezione attiva di qualsiasi tipo nota o sospetta allo screening o al basale (escludendo infezioni fungine del letto ungueale) o qualsiasi episodio maggiore di infezione che abbia richiesto il ricovero o il trattamento con antimicrobici per via e.v. nelle 8 settimane precedenti la visita di screening oppure di antimicrobici orali nelle 2 settimane precedenti e durante lo screening
    •Anamnesi di leucoencefalopatia multifocale progressiva (LMP) confermata o sospetta
    •Anamnesi di neoplasia maligna, incluse neoplasie maligne ematologiche e neoplasie solide, nei 10 anni precedenti lo screening
    •Stato di immunocompromissione
    •Immunizzazione con vaccino vivo attenuato nelle 6 settimane precedenti la randomizzazione
    •Controindicazioni alle premedicazioni obbligatorie (corticosteroidi e antistaminici) per reazioni correlate all’infusione (Infusion-Related Reaction, IRR), compresi antistaminici per glaucoma ad angolo chiuso
    •Nota presenza di altri disturbi neurologici
    •Qualsiasi malattia concomitante che potrebbe richiedere il trattamento cronico con corticosteroidi o immunosoppressori sistemici nel corso dello studio
    •Malattia rilevante e non controllata, come malattia cardiovascolare (compresa aritmia cardiaca), polmonare (inclusa pneumopatia ostruttiva), renale, epatica, endocrina o gastrointestinale, o qualsiasi altra malattia rilevante che potrebbe precludere la partecipazione del paziente allo studio
    •Anamnesi o presenza attiva di immunodeficienza primaria o secondaria (non farmaco-correlata)
    •Gravidanza o allattamento, o gravidanza programmata nel corso dello studio e nei 6 o 12 mesi (secondo le indicazioni locali approvate di ocrelizumab [Ocrevus]) successivi all’ultima somministrazione del medicinale dello studio
    •Assenza di accesso venoso periferico
    •Storia di abuso di alcol, medicinali o sostanze chimiche nei 12 mesi precedenti lo screening
    •Trattamento con qualsiasi agente sperimentale nelle 24 settimane precedenti lo screening o nelle cinque emivite del farmaco dello studio (adottando il periodo più lungo) o trattamento con qualsiasi procedura sperimentale per la SM
    •Pazienti trattati in precedenza con anti-CD20, se l’ultimo trattamento è avvenuto meno di 2 anni prima dello screening e/o la conta delle cellule B è al di sotto del limite inferiore dalla norma, e/o il trattamento è stato sospeso per motivi di sicurezza o mancanza di efficacia
    •Precedente trattamento con cladribina, atacicept e alemtuzumab
    •Trattamento con mitoxantrone nei 2 anni precedenti la visita basale o evidenza di cardiotossicità dopo l’uso di mitoxantrone o dose cumulativa totale superiore a 60 mg/m2
    •Precedente trattamento con qualsiasi medicinale immunomodulatorio o immunosoppressivo non elencato in precedenza, senza un periodo di washout adeguato, come indicato nelle indicazioni locali approvate
    •Se le indicazioni locali approvate non citano i requisiti di washout, si deve osservare un periodo di washout pari a 5 volte l’emivita del farmaco. Nello stabilire il periodo di washout adeguato si devono considerare anche gli effetti PD del medicinale precedente
    •Qualsiasi trattamento precedente con trapianto di midollo osseo e trapianto di cellule staminali ematopoietiche
    •Anamnesi di qualsiasi tipo di trapianto o terapia anti-rigetto
    •Trattamento con Ig per via e.v. o con plasmaferesi nelle 12 settimane precedenti la randomizzazione
    •Terapia sistemica con corticosteroidi nelle 4 settimane precedenti lo screening
    •Positività per l’antigene di superficie dell’epatite B
    •Sensibilità o intolleranza a uno qualsiasi dei componenti (compresi gli eccipienti) di ocrelizumab
    •Qualsiasi criterio di esclusione supplementare ai sensi delle indicazioni locali approvate (Ocrevus®), se più rigido dei criteri sopraelencati
    E.5 End points
    E.5.1Primary end point(s)
    1. Serum ocrelizumab area under the concentration-time curve (AUC[w1-12]) after SC administration compared to IV infusion from Day 1 to Week 12
    1. Area sottesa alla curva concentrazione¿tempo (AUCW1-12) di ocrelizumab dopo somministrazione s.c. rispetto a infusione e.v. dal giorno 1 alla settimana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 1 (Days 1, 2, 3, 5, 7, and 10), Weeks 2, 4, 8 and 12
    1. Alla settimana 1 (giorni 1, 2, 3, 5, 7 e 10), settimane 2, 4, 8 e 12
    E.5.2Secondary end point(s)
    1. Maximum serum concentration (Cmax) of ocrelizumab SC in patients with MS
    2. Total number of T1Gd+ lesions as detected by brain magnetic resonance imaging (MRI) at Weeks 8 and 24
    3. Total number of new or enlarging T2 lesions as detected by brain MRI at Weeks 12 and 24 relative to the previous scan
    4. Incidence and severity of adverse events, with severity determined according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0
    5. Change from baseline in targeted vital signs
    6. Change from baseline in targeted clinical laboratory test results
    7. Incidence of treatment-emergent antidrug antibodies (ADAs) to ocrelizumab after SC or IV administration relative to the presence of ADAs at baseline
    8. Relationship between ADA status to ocrelizumab and pharmacokinetics, pharmacodynamics, and safety
    9. Incidence of treatment-emergent antibodies to rHuPH20 after SC administration relative to the presence at baseline
    10. Relationships between antibodies to rHuPH20 and safety
    11. Percentage of patients achieving CD19+ B cell level <5 cells/microliter at Weeks 12 and 24
    1. Stabilire la concentrazione sierica massima (Cmax) di ocrelizumab s.c. in pazienti con SM
    2. Numero totale di lesioni T1Gd+ rilevate alla RM cerebrale delle settimane 8 e 24
    3. Numero totale di lesioni in T2 nuove o in espansione rilevate alla RM cerebrale rispettivamente delle settimane 12 e 24 rispetto alla scansione precedente
    4. Incidenza e gravità degli eventi avversi (Adverse Event, AE), determinandone la gravità in base ai criteri NCI CTCAE versione 5.0
    5. Variazione rispetto al basale di parametri vitali mirati
    6. Variazione rispetto al basale dei risultati di analisi cliniche di laboratorio mirate
    7. Incidenza di anticorpi antifarmaco (ADA) che emergono durante il trattamento e sono diretti contro ocrelizumab dopo somministrazione s.c. o e.v. rispetto alla presenza di ADA al basale
    8. Relazione tra stato degli ADA diretti contro ocrelizumab e farmacocinetica, farmacodinamica e sicurezza
    9. Incidenza di anticorpi che emergono durante il trattamento e sono diretti contro rHuPH20 dopo somministrazione s.c. rispetto alla loro presenza al basale
    10. Relazione tra anticorpi diretti contro rHuPH20 e sicurezza
    11. Percentuale di pazienti che conseguono un livello di cellule B CD19+ <5 cellule/mcL alle settimane 12 e 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Weeks 1, 2, 4, 8, 12, 16, 24 and 48
    2. At Weeks 8 and 24
    3. At Weeks 12 and 24
    4. Up to approximately 48 Weeks
    5. Baseline (Day 1), Weeks 2, 12, 24, 48 and safety follow up visit (every 24 weeks until 28 weeks after the last dose)
    6. Baseline (Day 1), Weeks 12, 22, 46 and safety follow up visit (every 24 weeks until 28 weeks after the last dose)
    7-10. Baseline (Day 1), Weeks 24, 48 and safety follow up visit (every 24 weeks until 28 weeks after the last dose)
    11. At Weeks 12 and 24
    1. Nelle settimane 1, 2, 4, 8, 12, 16, 24 e 48
    2. Alle settimane 8 e 24
    3. Alle settimane 12 e 24
    4. Fino a circa 48 settimane
    5. Basale (giorno 1), settimane 2, 12, 24, 48 e visita di controllo di sicurezza (ogni 24 settimane fino a 28 settimane dopo l'ultima dose)
    6. Basale (giorno 1), settimane 12, 22, 46 e visita di controllo di sicurezza (ogni 24 settimane fino a 28 settimane dopo l'ultima dose)
    7-10. Basale (giorno 1), settimane 24, 48 e visita di controllo di sicurezza (ogni 24 settimane fino a 28 settimane dopo l'ultima dose)
    11. Alle settimane 12 e 24
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity, radiological and clinical effects of SC administration.
    immunogenicità, effetti radiologici e clinici della somministrazione di SC
    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 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 Yes
    E.8.2.3.1Comparator description
    Ocrelizumab, concentrato per soluzione per infusione, 300 mg
    Ocrelizumab, Concentrate for Solution for Infusion, 300mg
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    France
    Italy
    Spain
    Czechia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.1.1In 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: 232
    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 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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 232
    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)
    The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    La Roche Global Policy on Continued Access to Investigational Medicinal Product è disponibile sul seguente sito web:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2021-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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