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    Summary
    EudraCT Number:2017-001313-93
    Sponsor's Protocol Code Number:MN39159
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-25
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-001313-93
    A.3Full title of the trial
    AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS
    AZ OCRELIZUMAB KEZELÉS HATÉKONYSÁGÁNAK ÉS BIZTONSÁGOSSÁGÁNAK NYÍLT ELRENDEZÉSŰ, 4 ÉVIG TARTÓ, EGYKAROS VIZSGÁLATA PROGRESSZÍV SZKLERÓZIS MULTIPLEXBEN SZENVEDŐ BETEGEK ESETÉBEN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis
    A.4.1Sponsor's protocol code numberMN39159
    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. 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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOcrelizumab
    D.3.2Product code RO4964913
    D.3.4Pharmaceutical form Concentrate for 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 INNOcrelizumab
    D.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.3Other descriptive nameOCRELIZUMAB
    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 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive multiple sclerosis (PMS)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis (MS) is a chronic autoimmune, inflammatory neurological disease of the central nervous system
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10053395
    E.1.2Term 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 evaluate the effectiveness of ocrelizumab treatment in patients with PMS disease course
    E.2.2Secondary objectives of the trial
    • To evaluate the effectiveness of ocrelizumab treatment in PMS patients using a range of patient-relevant measures and advanced magnetic resonance imaging (MRI) outcomes
    • To evaluate the safety and tolerability of ocrelizumab in PMS patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-65 years
    - Have a definite diagnosis of PMS
    - Expanded Disability Status Scale (EDSS) <=6.5 at screening
    - Have a length of disease duration since PMS disease symptom onset <=10 years if baseline EDSS <=5.0 and <=15 years if baseline EDSS >5.0
    - Have documented evidence of disability progression independent of relapse activity at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician’s judgment
    - Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
    - Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
    - For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
    - For both, PPMS patients according to revised McDonald 2010 criteria and RMS patients meeting criteria for PMS disease course as per Lublin et al. 2014, it will be documented whether or not they fulfill each of the three following McDonald Criteria:
    o Evidence for Dissemination in Space (DIS) in the brain based on >=1 T2 lesion(s) in at least one area characteristic for MS (periventricular, juxtacortical, or infratentorial).
    o Evidence for DIS in the spinal cord based on >=2 T2 lesions in the cord.
    o Positive findings in a cerebrospinal fluid (CSF) specimen
    E.4Principal exclusion criteria
    - Relapsing-remitting multiple sclerosis (RRMS) at screening.
    - Inability to complete an MRI
    - Gadolinium (Gd) intolerance
    - Known presence of other neurological disorders, including but not limited to, the following:
    o History of ischemic cerebrovascular disorders or ischemia of the spinal cord.
    o History or known presence of Central nervous system (CNS) or spinal cord tumor
    o History or known presence of potential metabolic causes of myelopathy
    o History or known presence of infectious causes of myelopathy
    o History of genetically inherited progressive CNS degenerative disorder
    o Neuromyelitis optica.
    o History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease
    o History of severe, clinically significant brain or spinal cord trauma
    Exclusions Related to General Health
    - Pregnancy or lactation
    - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressant’s during the course of the study
    - History or currently active primary or secondary immunodeficiency.
    - Lack of peripheral venous access.
    - Hypersensitivity to ocrelizumab or to any of its excipients.
    - Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study.
    - Active infections must be treated and resolved before possible inclusion in the study.
    - Patients in a severely immunocompromised state until the condition resolves
    - Patients with known active malignancies or being actively monitored for recurrence of malignancy
    - Patients who have or have had confirmed progressive multifocal leukoencephalopathy (PML)
    Exclusions Related to Medications
    - All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted
    - Treatment with any investigational agent within 24 weeks of screening or five half-lives of the investigational drug or treatment with any experimental procedures for MS within 24 weeks of screening
    - Previous treatment with B-cell targeted therapies
    - Any previous treatment with alemtuzumab , total body irradiation, or bone marrow transplantation.
    - Previous treatment with natalizumab, daclizumab or fingolimod in the last 8 weeks.
    - Previous treatment with natalizumab where PML has not been excluded according to a specific algorithm
    - Patients previously treated with teriflunomide, unless an accelerated elimination procedure is implemented until its completion before screening visit
    - Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks.
    - Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks.
    - Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label, such as psychosis not yet controlled by a treatment and hypersensitivity to any of the constituents
    - Treatment with fampridine/dalfampridine or other symptomatic MS treatment unless on stable dose for >=30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the treatment period
    Exclusions Related to Laboratory Findings
    - Positive serum β human chorionic gonadotropin (hCG) measured at screening
    - Positive screening tests for hepatitis B or hepatitis C
    Retesting before baseline: any abnormal screening laboratory value that is clinically relevant should be retested only once in order to rule out any progressive or uncontrolled underlying condition. The last value before randomization must meet study criteria
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients with no evidence of progression sustained for at least 24 weeks (NEP)
    2. Proportion of patients with NEP and no active disease (NEPAD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. From baseline to Week 96, Week 96 to Week 192 and baseline to Week 192
    E.5.2Secondary end point(s)
    1. Change from baseline in cognitive function as measured by the symbol digit modalities test
    2. Change from baseline in the patient-reported outcomes including Multiple Sclerosis Impact Scale -29, Multiple Sclerosis Walking scale -12 items, ABILHAND Questionnaire, and Fatigue Scale for Motor and Cognitive (FSMC) function
    3. Mean change from baseline in the EDSS score over the course of the study
    4. Time to onset of first confirmed disability progression (as measured by EDSS) sustained for at least 24 weeks
    5. Time to onset of first >=20% increase in timed 25-foot walk test sustained for at least 24 weeks
    6. Time to onset of first >=20% increase in 9-hole peg test sustained for at least 24 weeks
    7. Proportion of patients with NEP
    8. Proportion of patients with NEPAD
    9. Time to treatment or study discontinuation
    10. Whole brain volume change
    11. Cortical gray matter volume change
    12. Total T2 lesion volume change
    13. Slowly evolving lesion (SEL) change
    14. Change in total T1 Gd+ lesion
    15. Measurement of T1 gadolinium (Gd)-enhancement in new focal T2 lesions, SELs, persistent areas of non-SEL T2 lesions, and normal-appearing brain tissue
    16. Cerebral white matter volume change
    17. Change in Gd-enhancing fluid-attenuated inversion-recovery (FLAIR) meningeal lesions
    18. Spectroscopic MR: measure of the relative signal amplitude of N-acetyl aspartate, and choline to creatine
    19. Measure of phase (iron) rim lesions by T2*
    20. Change in brain tissue integrity as measured by signal mass analysis
    21. Rate and nature of adverse events
    22. Changes in clinical laboratory results
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. From baseline to Weeks 48, 96, 144, 192
    4-6. From baseline to Week 192
    7-8. From Week 24 to Week 96, Week 24 to Week 192 and Week 48 to Week 192
    9. From baseline to Week 192
    10-20. From baseline to Weeks 48, 96, 144, 192
    21-22. From baseline to Week 192
    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 No
    E.6.7Pharmacodynamic No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA79
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Algeria
    Bosnia and Herzegovina
    Brazil
    Canada
    Colombia
    Costa Rica
    Czech Republic
    Denmark
    Egypt
    France
    Guatemala
    Hungary
    Ireland
    Italy
    Kuwait
    Lebanon
    Mexico
    Morocco
    Netherlands
    Panama
    Poland
    Russian Federation
    Saudi Arabia
    Spain
    United Arab Emirates
    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
    The end of the study is defined as the last patient last visit in the B-cell monitoring of the follow-up period
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 600
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 374
    F.4.2.2In the whole clinical trial 600
    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 Sponsor will offer continued access to Sponsor study drug (ocrelizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined below. Please refer to section 4.3.5 of the protocol.
    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 Decision2018-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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