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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2020-004128-41
    Sponsor's Protocol Code Number:WN42086
    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:2021-10-07
    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 number2020-004128-41
    A.3Full title of the trial
    A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
    STUDIO MULTICENTRICO DI FASE III, RANDOMIZZATO, IN DOPPIO CIECO, A DOPPIO MASCHERAMENTO PER VALUTARE LA SICUREZZA E L'EFFICACIA DI OCRELIZUMAB RISPETTO A FINGOLIMOD IN BAMBINI E ADOLESCENTI AFFETTI DA SCLEROSI MULTIPLA RECIDIVANTE-REMITTENTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis
    Uno studio per valutare la sicurezza e l'efficacia di ocrelizumab in confronto a fingolimod in bambini e adolescenti con sclerosi multipla recidivante-remittente
    A.3.2Name or abbreviated title of the trial where available
    Operetta 2
    Operetta 2
    A.4.1Sponsor's protocol code numberWN42086
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/493/2020
    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. Hoffmann-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.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    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 GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD
    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 nameN/A
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFINGOLIMOD
    D.3.9.1CAS number 162359-55-9
    D.3.9.2Current sponsor codeRO7079904
    D.3.9.4EV Substance CodeSUB31908
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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 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 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 GILENYA - 0.25 MG - CAPSULE RIGIDE - USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD
    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 nameN/A
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFINGOLIMOD
    D.3.9.1CAS number 162359-55-9
    D.3.9.2Current sponsor codeRO7079904
    D.3.9.4EV Substance CodeSUB31908
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 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: 3
    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 GmbH
    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 nameN/A
    D.3.2Product code [N/A]
    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.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 typeanticorpo monoclonale umanizzato
    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 placeboCapsule
    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 placeboConcentrate for solution for injection/infusion
    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
    Relapsing-Remitting Multiple Sclerosis
    Sclerosi multipla recidivante-remittente
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis is a disabling disease of brain and spinal cord that disrupts flow of information within brain, characterized by flare-ups with periods of remission in between (relapsing remitting)
    La SM è una mal. invalidante del cerv. e del mid. s. che interrompe il flusso di info. all'interno del cerv., caratterizzata da riacutizzaz. con periodi di remissione interm. (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 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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 non-inferiority of ocrelizumab compared with fingolimod, based on Protocol-defined annualized relapse rate (ARR)
    • Dimostrare la non inferiorità di ocrelizumab rispetto a fingolimod, sulla base del tasso di recidiva annualizzato (ARR) definito dal protocollo
    E.2.2Secondary objectives of the trial
    • To demonstrate non-inferiority of ocrelizumab compared with fingolimod based on the number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI
    • To demonstrate the superiority of ocrelizumab versus fingolimod based on the number of new or enlarging T2-hyperintense lesions, number of T1 gadolinium lesions and protocol-defined ARR
    • To evaluate the safety of ocrelizumab administered by intravenous (IV) infusion every 24-weeks compared with fingolimod administered once a day (QD) by mouth (PO)
    • To assess the pharmacokinetics of ocrelizumab in all children/adolescents enrolled in this study
    • To assess the pharmacodynamics in all children/adolescents enrolled in this study, as measured by blood B-cell count
    • To evaluate the immune response to ocrelizumab
    • Per dimostrare la non inferiorità di ocrelizumab rispetto a fingolimod in base al numero di lesioni iperintense in T2 nuove o in espansione (lesioni in T2) rilevate dalla risonanza magnetica cerebrale
    • Dimostrare la superiorità di ocrelizumab rispetto a fingolimod in base al numero di lesioni iperintense in T2 nuove o in espansione, numero di lesioni al gadolinio in T1 e ARR definita dal protocollo
    • Valutare la sicurezza di ocrelizumab somministrato per via endovenosa (IV) in infusione ogni 24 settimane rispetto a fingolimod somministrato una volta al giorno (QD) per bocca (PO)
    • Per valutare la farmacocinetica di ocrelizumab in tutto bambini/adolescenti arruolati in questo studio
    • Per valutare la farmacodinamica in tutti i bambini/adolescenti arruolati in questo studio, misurata dalla conta delle cellule B nel sangue
    • Per valutare la risposta immunitaria a ocrelizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria
    • Able to comply with the study protocol, in the investigator's judgment
    • Age between >10 to <18 years at randomization
    • Body weight >=25 kilograms
    • Children and adolescents must have received all childhood vaccinations as per local and/or national recommendations for childhood vaccination against infectious diseases
    • Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 24 weeks after the final dose of ocrelizumab/ocrelizumab placebo and for 2 months after the final dose of fingolimod/fingolimod placebo
    Inclusion Criteria Related to Pediatric Multiple Sclerosis
    • Diagnosis of relapsing-remitting multiple sclerosis (RRMS) in accordance with the international pediatric multiple sclerosis study group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 (or the most current revision of the IPMSSG criteria or McDonald criteria at the time of study start)
    • Confirmation of the diagnosis of Pediatric RRMS by the Independent Review of Eligibility Committee prior to randomization
    • Expanded disability status scale (EDSS) at screening: 0-5.5, both inclusive
    • Neurologic stability for >=30 days prior to screening, and between screening and Day 1
    • At least one relapse during the year prior to screening or two relapses in the previous two years prior to screening or evidence of at least one Gd enhancing lesion on MRI within 6 months prior to randomization (including screening MRI)
    Criteri generali di inclusione
    • In grado di rispettare il protocollo di studio, a giudizio dello sperimentatore
    • Età compresa tra >10 e <18 anni alla randomizzazione
    • Peso corporeo >=25 chilogrammi
    • I bambini e gli adolescenti devono aver ricevuto tutte le vaccinazioni per l'infanzia secondo le raccomandazioni locali e/o nazionali per la vaccinazione infantile contro le malattie infettive
    • Le pazienti in età fertile devono accettare di rimanere in astinenza (astenersi da rapporti eterosessuali) o utilizzare contraccettivi durante il periodo di trattamento e per almeno 24 settimane dopo la dose finale di ocrelizumab/ocrelizumab placebo e per 2 mesi dopo la dose finale di fingolimod/fingolimod placebo
    Criteri di inclusione relativi alla sclerosi multipla pediatrica
    • Diagnosi di sclerosi multipla recidivante-remittente (SMRR) in conformità ai criteri del gruppo di studio internazionale sulla sclerosi multipla pediatrica (IPMSSG) per la SM pediatrica, versione 2012 o ai criteri McDonald 2017 (o alla revisione più recente dei criteri IPMSSG o dei criteri McDonald al momento dell'inizio dello studio)
    • Conferma della diagnosi di SMRR pediatrica da parte dell'Independent Review of Eligibility Committee prima della randomizzazione
    • Scala ampliata dello stato di disabilità (EDSS) allo screening: 0-5,5, entrambi inclusi
    • Stabilità neurologica per >=30 giorni prima dello screening e tra lo screening e il Giorno 1
    • Almeno una recidiva nell'anno precedente lo screening o due recidive nei due anni precedenti lo screening o evidenza di almeno una lesione potenziante il Gd alla risonanza magnetica entro 6 mesi prima della randomizzazione (inclusa la risonanza magnetica per lo screening)
    E.4Principal exclusion criteria
    Exclusions Related to General Health
    • Pregnancy or lactation
    • Known presence or suspicion of other neurologic disorders that may mimic MS
    • Aquaporin-4 positive and/or myelin oligodendrocyte glycoprotein antibody positive at screening
    • Clinical or laboratory findings at first presentation not typically for MS
    • Abnormal findings in the cerebrospinal fluid at first presentation
    • Atypical magnetic resonance imaging (MRI) findings
    • Significant uncontrolled somatic diseases or any other significant condition
    • Known active bacterial, viral, fungal, mycobacterial infection, or other infection
    • Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to Day 1 visit or oral anti-infective agents within 2 weeks prior to Day 1 visit
    • History or known presence of recurrent or chronic infection
    • Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation
    • History or laboratory evidence of clinically significant coagulation disorders
    • Peripheral venous access that precludes IV administration and venous blood sampling
    • Inability to complete MRI scan
    • Teeth braces interfering with MRI acquisition
    • History of cancer
    • Currently active or history of alcohol or drug abuse
    Exclusion Criteria Related to General Health Specific to Fingolimod Treatment
    • History of symptomatic bradycardia, recurrent syncope, significant QT prolongation. Patients having risk factors for QT prolongation such as hypokalemia or congenital QT prolongation, and uncontrolled hypertension
    • Patients who in the previous 6 months had myocardial infarction, unstable angina pectoris, stroke/transient ischemic attack, decompensated heart failure, or New York Heart Association Class III/IV heart failure
    • Patients with severe cardiac arrhythmias
    • Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, sick-sinus syndrome or sinoatrial heart block
    • Patients with a baseline QTc interval >=500 milliseconds
    • Presence of macular edema
    • Presence of any pulmonary conditions, as determined by the investigator
    • History of any type of epileptic seizure(s) as well as psychogenic nonepileptic seizure(s) during the past 12 months before screening
    • Patients with chronic liver or biliary disease, acute or chronic pancreatitis
    Exclusion Criteria Related to Medications
    • History of a severe allergic or anaphylactic reaction to humanized or murine MAbs or known hypersensitivity to any component of ocrelizumab solution
    • Contraindications to or intolerance of oral or IV corticosteroids, antihistamines, or antipyretics
    • Treatment with any investigational agent within 24 weeks of screening or 5 half-lives
    • Previous treatment with B-cell-targeted therapies
    • Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
    • Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate within 24 months prior to treatment allocation
    • Treatment with natalizumab within 12 months prior to randomization
    • Previous treatment with fingolimod
    • Treatment with teriflunomide or any other S1P receptor modulator within 24 weeks prior to treatment allocation
    • Treatment with dimethyl fumarate within 4 weeks prior to treatment allocation
    • Treatment with intravenous immunoglobulin within 12 weeks prior to treatment allocation
    • Treatment with plasmapheresis within 4 weeks prior to treatment allocation
    • Completion of systemic corticosteroid therapy within 30 days prior to screening
    Exclusion Criteria Related to Medications Specific to Fingolimod
    Treatment
    • History of a severe allergic reaction or known hypersensitivity to any component of fingolimod tablet
    • Treatment with beta-blockers or calcium-channel blockers
    • Patient treated with digoxin, anticholinesteratic agents, pilocarpine
    • Anti-arrhythmic drugs of Class Ia and III
    Criteri generali di inclusione
    • In grado di rispettare il protocollo di studio, a giudizio dello sperimentatore
    • Età compresa tra >10 e <18 anni alla randomizzazione
    • Peso corporeo >=25 chilogrammi
    • I bambini e gli adolescenti devono aver ricevuto tutte le vaccinazioni per l'infanzia secondo le raccomandazioni locali e/o nazionali per la vaccinazione infantile contro le malattie infettive
    • Le pazienti in età fertile devono accettare di rimanere in astinenza (astenersi da rapporti eterosessuali) o utilizzare contraccettivi durante il periodo di trattamento e per almeno 24 settimane dopo la dose finale di ocrelizumab/ocrelizumab placebo e per 2 mesi dopo la dose finale di fingolimod/fingolimod placebo
    Criteri di inclusione relativi alla sclerosi multipla pediatrica
    • Diagnosi di sclerosi multipla recidivante-remittente (SMRR) in conformità ai criteri del gruppo di studio internazionale sulla sclerosi multipla pediatrica (IPMSSG) per la SM pediatrica, versione 2012 o ai criteri McDonald 2017 (o alla revisione più recente dei criteri IPMSSG o dei criteri McDonald al momento dell'inizio dello studio)
    • Conferma della diagnosi di SMRR pediatrico da parte dell'Independent Review of Eligibility Committee prima della randomizzazione
    • Scala ampliata dello stato di disabilità (EDSS) allo screening: 0-5,5, entrambi inclusi
    • Stabilità neurologica per >=30 giorni prima dello screening e tra lo screening e il Giorno 1
    • Almeno una recidiva nell'anno precedente lo screening o due recidive nei due anni precedenti lo screening o evidenza di almeno una lesione potenziante il Gd alla risonanza magnetica entro 6 mesi prima della randomizzazione (inclusa la risonanza magnetica per lo screening)
    E.5 End points
    E.5.1Primary end point(s)
    1. Protocol-defined annualized relapse rate (ARR) (non-inferiority)
    1. Tasso di recidiva annualizzato (ARR) definito dal protocollo (non inferiorità)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 2 years
    1. Fino a circa 2 anni
    E.5.2Secondary end point(s)
    1. Number of new or enlarging T2 lesions as detected by brain MRI during the double-blind period
    2. Number of new or enlarging T2 lesions by Week 96 (non-inferiority)
    3. Protocol-defined ARR by Week 96 (non-inferiority)
    4. Number of T1 gadolinium (Gd) lesions at Week 12
    5. Protocol-defined ARR during the double-blind period (superiority)
    6. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
    7. Change from baseline in targeted vital signs and clinical significant abnormalities in electrocardiogram (ECG) parameters
    8. Change from baseline in targeted clinical laboratory test results
    9. Concentrations of ocrelizumab at indicated time points
    10. Levels of CD19 B-cell count in blood
    11. Prevalence of anti-drug antibodies (ADAs) against ocrelizumab at baseline
    12. Incidence of ADAs against ocrelizumab during the study
    1. Numero di lesioni T2 nuove o in espansione rilevate dalla risonanza magnetica cerebrale durante il periodo in doppio cieco
    2. Numero di lesioni T2 nuove o in espansione entro la settimana 96 (non inferiorità)
    3. ARR definito dal protocollo entro la settimana 96 (non inferiorità)
    4. Numero di lesioni da gadolinio (Gd) in T1 alla settimana 12
    5. ARR definito dal protocollo durante il periodo in doppio cieco (superiorità)
    6. Incidenza e gravità degli eventi avversi, con gravità determinata secondo i criteri comuni di terminologia per gli eventi avversi del National Cancer Institute, versione 5.0 (NCI CTCAE v5.0)
    7. Variazione dal basale nei segni vitali mirati e anomalie cliniche significative nei parametri dell'elettrocardiogramma (ECG)
    8. Variazione rispetto al basale nei risultati dei test di laboratorio clinici mirati
    9. Concentrazioni di ocrelizumab ai tempi indicati
    10. Livelli di conta delle cellule B CD19 nel sangue
    11. Prevalenza di anticorpi anti-farmaco (ADA) contro ocrelizumab al basale
    12. Incidenza di ADA contro ocrelizumab durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 2 years
    2-3. At Week 96
    4. At Week 12
    5. Up to approximately 2 years
    6. Up to 48 weeks from the date of last infusion of ocrelizumab
    7-8. Baseline to 48 weeks from the date of last infusion of ocrelizumab
    9. Weeks 1, 2, 12, 24, 36, 48, 60, 72, 84 and 96
    10. Baseline to 48 weeks from the date of last infusion of ocrelizumab
    11. At Baseline (Week -8 to -1)
    12. Weeks 1, 24, 48, 72, 96; OLE Period: Day 1 of Dose 1 and of all doses afterword's; Safety Follow up: 12, 36, 60, 84, 108, 132 weeks from the date of last infusion of ocrelizumab
    1. Fino a circa 2 anni
    2-3. Alla settimana 96
    4. Alla settimana 12
    5. Fino a circa 2 anni
    6. Fino a 48 settimane dalla data dell'ultima infusione di ocrelizumab
    7-8. Al basale a 48 settimane dalla data dell'ultima infusione di ocrelizumab
    9. Settimane 1, 2, 12, 24, 36, 48, 60, 72, 84 e 96
    10. Al basale a 48 settimane dalla data dell'ultima infusione di ocrelizumab
    11. Al basale (settimana da -8 a -1)
    12. Settimane 1, 24, 48, 72, 96; Periodo OLE: Giorno 1 della Dose 1 e di tutte le dosi successive; Follow-up di sicurezza: 12, 36, 60, 84, 108, 132 settimane dalla data dell'ultima infusione di ocrelizumab
    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 No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Australia
    Brazil
    Canada
    Mexico
    Russian Federation
    Serbia
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Spain
    Switzerland
    United Kingdom
    Czechia
    Argentina
    Greece
    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
    The end of study is defined as either the last patient, last visit (LPLV) of the study or the LPLV in the SFU or B-cell monitoring period of the SFU, whichever is later, or when the Sponsor decides to discontinue the study or development program in pediatric MS.
    La fine dello studio è definita come l'ultimo paziente, l'ultima visita (LPLV) dello studio o l'LPLV nel periodo di monitoraggio dell'SFU o delle cellule B dell'SFU, se successivo, o quando lo Sponsor decide di interrompere lo studio o programma di sviluppo nella SM pediatrica.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 211
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Informed consent for study participation signed by the parents or a legal guardian, with patient assent obtained verbally and when possible, in writing, from all pediatric patients old enough to fully comprehend the assent document
    Consenso informato per la partecipazione allo studio firmato dai genitori o da un tutore legale, con assenso del paziente ottenuto verbalmente e quando possibile, per iscritto, da tutti i pazienti pediatrici di età sufficiente per comprendere appieno
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 233
    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)
    Currently, the Sponsor does not have any plans to provide ocrelizumab or any other study treatments to patients who have completed the study. The Sponsor may evaluate whether to continue providing ocrelizumab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following website: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Attualmente, lo Sponsor non ha in programma di fornire ocrelizumab o altri trattamenti in studio ai pazienti che hanno completato lo studio. Lo Sponsor può valutare se continuare a fornire ocrelizumab in conformità con la Roche Global Policy on Continued Accesso al medicinale sperimentale, disponibile al seguente sito Web:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Connect4Children (C4C)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA