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    Summary
    EudraCT Number:2016-002937-31
    Sponsor's Protocol Code Number:MA30143
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-002937-31
    A.3Full title of the trial
    An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis
    A.4.1Sponsor's protocol code numberMA30143
    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/F07-01
    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/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 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 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 typeMonoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name 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 nameOcrelizumab
    D.3.2Product code RO4964913/F07-01
    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/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 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 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 typeMonoclonal 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
    Relapsing remitting multiple sclerosis (RRMS)
    E.1.1.1Medical condition in easily understood language
    RRMS is a chronic neurological immune-mediated disease that occurs when the insulating membrane (myelin) around nerve cells in the central nervous system is damaged
    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 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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10039720
    E.1.2Term Sclerosis multiple
    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 in early stage of RRMS
    E.2.2Secondary objectives of the trial
    - To evaluate different clinical measures related to disease progression in early stage of RRMS disease
    - To evaluate the safety and tolerability of ocrelizumab in early stage of RRMS
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - T AND B CELLS IMPACT SUBSTUDY PROTOCOL (Appendix 8 of the MA30143 protocol for France) Version 3
    Full title : A SUBSTUDY TO EVALUATE THE INDIRECT IMPACT OF OCRELIZUMAB ON THE T AND B CELL IMMUNE SYSTEM IN RELAPSING-REMITTING MULTIPLE SCLEROSIS PATIENTS
    Objectives:
    Primary: To evaluate the indirect impact of ocrelizumab-dependant B cell depletion on T cell subsets and functions in naïve RRMS patients
    To decipher the indirect impact of ocrelizumab on B cell repopulation
    Secondary: To assess the potential relationship between immunological biomarkers levels and clinical and/or subclinical change assessed by neurological markers in naïve RRMS patients treated with ocrelizumab.

    - IMMUNE SUBSTUDY PROTOCOL (Appendix 9 of the MA30143 protocol) Version 2
    Full title : A SUBSTUDY TO RESEARCH IMMUNOLOGICAL PARAMETERS AND SIGNATURES ASSOCIATED WITH OCRELIZUMAB TREATMENT IN EARLY STAGE RELAPSING REMITTING MULTIPLE SCLEROSIS
    Objective: To explore immunological changes associated with ocrelizumab treatment in a treatment naïve, early stage MS population. This substudy will help to assess the potential relationship between immunological biomarker levels and clinical and/or subclinical changes assessed by neurological markers in naïve RRMS patients treated with ocrelizumab.

    - OCRELIZUMAB SHORTER INFUSION SUBSTUDY (Appendix 10 of the MA30143 protocol) Version 1
    Full title : A SUBSTUDY TO EVALUATE THE SAFETY OF A SHORTER INFUSION OF OCRELIZUMAB IN PATIENTS WITH EARLY STAGE RELAPSING REMITTING MULTIPLE SCLEROSIS
    ASSOCIATED WITH MA30143 CORE STUDY
    Primary objective: To assess the proportion of patients with infusion-related reactions (IRRs) following shorter duration infusions of ocrelizumab as compared to conventional infusions in the study population
    Secondary objective: To evaluate the IRR of ocrelizumab in the study population
    E.3Principal inclusion criteria
    - Able to comply with the study protocol, in the investigator’s judgment
    - Age 18 − 55 years, inclusive
    - Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
    - Have a length of disease duration, from first documented clinical attack consistent with multiple sclerosis (MS) disease of <= 3 years
    - Within the last 12 months: one or more clinically reported relapse(s) or one or more signs of MRI activity
    - Expanded Disability Status Scale (EDSS) of 0.0 to 3.5 inclusive, at screening
    - For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months or longer after the last dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
    E.4Principal exclusion criteria
    - Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
    - Inability to complete a Magnetic resonance imaging (MRI)
    - Known presence of other neurological disorders, including but not limited to, the following:
    • History of ischemic cerebrovascular disorders or ischemia of the spinal cord
    • History or known presence of central nervous system (CNS) or spinal cord tumor
    • History or known presence of potential metabolic causes of myelopathy
    • History or known presence of infectious causes of myelopathy
    • History of genetically inherited progressive CNS degenerative disorder
    • Neuromyelitis optica
    • History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease
    • History of severe, clinically significant brain or spinal cord trauma
    Exclusions Related to General Health
    - Pregnancy or lactation
    - Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug
    - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
    - History or currently active primary or secondary immunodeficiency
    - Lack of peripheral venous access
    - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
    - Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study
    - Congestive heart failure [NYHA] III or IV functional severity).
    - Known active bacterial, viral, fungal, mycobacterial infection or other infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
    - History of major opportunistic infections
    - History or known presence of recurrent or chronic infection
    - History of malignancy, including solid tumors and hematological malignancies
    - History of alcohol or drug abuse within 24 weeks prior to baseline
    - History or laboratory evidence of coagulation disorders
    Exclusions Related to Medications
    - Received any prior approved Disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
    - Received a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
    - 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
    - Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
    - Previous treatment with B-cell targeted therapies
    - Systemic corticosteroid therapy within 4 weeks prior to screening.
    - Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies
    - Treatment with IV Immunoglobulin within 12 weeks prior to baseline
    - Treatment with investigational DMT
    - History of recurrent aspiration pneumonia requiring antibiotic therapy
    - Treatment with fampridine/dalfamipridine unless on stable dose for ≥ 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the 96-week treatment period
    Exclusions Related to Laboratory Findings
    - Positive serum β human chorionic gonadotropin measured at screening
    - Positive screening tests for hepatitis B
    - Lymphocyte count below lower limit of normal
    - CD4 count<250/μL
    - Aspartate aminotransferase/ serum glutamic oxaloacetic transaminase or alanine aminotransferase/serum glutamic pyruvic transaminase >= 3.0 × Upper limit of normal
    - Serum creatinine >1.4 mg/dL for women or > 1.6 mg/dL for men
    - Hemoglobin < 8.5 g/dL, Platelet count <100,000/μL, Absolute neutrophil count <1.0 × 10 3/μL
    E.5 End points
    E.5.1Primary end point(s)
    Disease progression
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 4 years
    E.5.2Secondary end point(s)
    1. Time to onset of confirmed disability progression (CDP) sustained for at least 24 weeks and 48 weeks
    2. Proportion of patients who have confirmed disability improvement (CDI), CDP for at least 24 weeks and 48 weeks at Years 1, 2 and 4
    3. Proportion of patients who have improved, stable or worsened disability compared with baseline measured by EDSS annually
    4. Mean change from baseline in EDSS score over the course of the study
    5. Time to first protocol-defined event of disease activity
    6. Time to first relapse
    7. Annualized relapse rate
    8. Proportion of patient relapse free by Weeks 48, 96, 144 and 192
    9. Proportion of patients with no evidence of protocol-defined disease activity (NEDA) over Week 96, Week 144 and Week 192
    10. Proportion of patients with no evidence of progression sustained for at least 24 weeks on all the following three components (CDP; 20% increase in timed 25 Foot Walk Test [T25FWT]; 20% increase in timed 9 hole peg test [9HPT]) between baseline and Week 96/192
    11. Proportion of patients with no active disease between Baseline and Week 96/192
    12. Change from baseline of multiple sclerosis functional composite (MSFC) and its composites (T25FW, 9HP, and Paced Auditory Serial Addition Test [PASAT]) over time
    13. Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) performed annually
    14. Total number of T1 Gd-enhancing lesions; and new and/or enlarging T2 lesion as detected by brain MRI over time
    15. Change in T1 volume over time
    16. Total number of fluid-attenuated inversion-recovery (FLAIR) lesion counts as detected by brain MRI over time
    17. Change in brain volume (including white and grey matter fractions) as detected by brain MRI over time
    18. Time to treatment discontinuation/switch
    19. Employment status score (Work Productivity and Activity Impairment Questionnaire [WPAI])
    20. SymptoMScreen score
    21. Quality of life score (Multiple Sclerosis Impact Scale [MSIS]-29)
    22. Rate and nature of adverse events
    23. Changes in vital signs, physical and neurological examinations, clinical laboratory results, locally reviewed MRI for safety and concomitant medications
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-23. Up to 4 years / 192 wks of the study duration, with interim assessments at week 48, 96, and 144
    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 concerned3
    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 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
    Argentina
    Australia
    Brazil
    Canada
    Kuwait
    Lebanon
    Mexico
    Turkey
    United States
    Austria
    Belgium
    Croatia
    Denmark
    France
    Germany
    Hungary
    Italy
    Norway
    Poland
    Portugal
    Slovakia
    Slovenia
    Sweden
    United Kingdom
    Bulgaria
    Netherlands
    Romania
    Spain
    Switzerland
    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 the study per protocol S3.2 is LPLV in Safety Follow-up or last patient Week 192 visit (end of treatment period) or early treatment discontinuation visit, whichever occurs later. In addition, the study may be discontinued on Sponsor Decision per protocol S4.7.3.
    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 months10
    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 months11
    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: 1225
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 1225
    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)
    Patients may be eligible to receive ocrelizumab as part of an extension study (MN39158) to evaluate long-term effectiveness and safety as described in protocol section 3.1.3.
    The Sponsor will offer continued access to Roche IMP (ocrelizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product (http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf) as outlined in protocol section 4.3.5
    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 Decision2017-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-27
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