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    Summary
    EudraCT Number:2015-005597-38
    Sponsor's Protocol Code Number:MA30005
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-03-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-005597-38
    A.3Full title of the trial
    An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    CASTING
    A.4.1Sponsor's protocol code numberMA30005
    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
    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 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
    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)
    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 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 assess the efficacy of ocrelizumab 600 mg intravenous (IV) given every 24 weeks on the basis of the following endpoint
    - Proportion of patients who have no evidence of disease activity
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of ocrelizumab 600 mg IV given every 24 weeks on the basis of the following endpoints
    - Proportions of patients free from a protocol-defined event of disease activity
    - Time to first protocol-defined event of disease activity
    - Change in Expanded Disability Status Scale (EDSS)
    - Proportion of patients who have Confirmed Disability Improvement (CDI), Confirmed Disability Progression (CDP) or stable disability
    - Annualized rate of protocol-defined relapses
    - Time to onset of first protocol-defined relapse, 24 weeks CDP, first new and/or enlarging T2 lesion
    - Total number of T1 Gd-enhanced lesions detected by brain MRI
    - Total number of new/enlarging T2 lesions detected by brain MRI
    - Volume and number of new and/or enlarging T2 hyperintense lesions
    - Change in T1 hypointense lesions
    - Change in cognitive performance
    •To evaluate the safety and tolerability of ocrelizumab 600 mg IV given every 24 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-55 years
    - Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
    - Have a length of disease duration, from first symptom, of < 10 years. If the date of first symptom is unknown, then the diagnosis of RRMS should be of ≤ 5 years
    - Have received no more than two prior disease modifying treatments (DMTs), and the discontinuation of the most recent DMT was due to lack of efficacy
    - Suboptimal disease control while on a DMT
    - EDSS of 0.0 to 4.0, 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 after the last dose of study drug
    E.4Principal exclusion criteria
    - Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing MS
    - Inability to complete an MRI
    - Known presence of other neurological disorders
    Exclusions Related to General Health
    - 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
    - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
    - History of opportunistic infections
    - History or known presence of recurrent or chronic infection
    - History of malignancy
    - Congestive heart failure
    - Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
    Exclusions Related to Medications
    - Receipt of 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 (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
    - Treatment with fampridine/dalfamipridine (Fampyra®)/Ampyra®) unless on stable dose for >= 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the 96-week treatment period.
    - Contraindications to or intolerance of oral or IV corticosteroids, according to the country label, including a) Psychosis not yet controlled by a treatment; b) Hypersensitivity to any of the constituents
    - Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
    - Systemic corticosteroid therapy within 4 weeks prior to screening
    - Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
    - Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine or methotrexate
    - Treatment with fampridine/dalfamipridine (Fampyra®)/Ampyra®) unless on stable dose for >= 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the 96-week treatment period.
    - Previous treatment with natalizumab unless natalizumab was discontinued because of persistent anti-natalizumab antibodies
    - Treatment with IV immunoglobulin (Ig) within 12 weeks prior to baseline
    - Any previous treatment with an investigational MS DMT not yet approved at time of screening
    Exclusions Related to Laboratory Findings
    - Positive serum β human chorionic gonadotropin (hCG) measured at screening
    - Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral DNA polymerase chain reaction [PCR]) or hepatitis C (HepCAb)
    - Lymphocyte count below lower limit of normal (LLN)
    - CD4 count<250/mcL
    - Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT) /serum glutamic pyruvic transaminase (SGPT)=> 3.0 × the upper limit of normal (ULN)
    - Platelet count <100,000/µL (<100 × 109/L)
    - Absolute neutrophil count <1.0 × 103/mcL
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients who have no evidence of disease activity (NEDA), as per protocol defined events over 96-weeks (with MRI baseline at Week 8)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 96 weeks
    E.5.2Secondary end point(s)
    1. Proportions of patients free from a protocol-defined event of disease activity during a 24-week period and a 48-week period
    2. Time to first protocol-defined event of disease activity
    3. Change in EDSS from Baseline to Week 96
    4. Proportion of patients who, over a 96-week period, have CDI, CDP or stable disability
    5. Annualized rate of protocol-defined relapses at Week 96
    6. Time to onset of first protocol-defined relapse
    7. Time to onset of 24 weeks CDP
    8. Time to onset of first new and/or enlarging T2 lesion
    9. Total number of T1 Gd-enhanced lesions detected by brain MRI at Weeks 24, 48 and 96
    10. Change in total T2 lesion volume detected by brain MRI from Baseline to Weeks 96
    11. Change in T1 hypointense volume from Baseline to Weeks 48 and 96
    12. Change in brain volume from baseline measured at Weeks 24, 48 and 96
    13. Volume and number of new and/or enlarging T2 hyperintense lesions from baseline to Weeks 24, 48 and 96
    14. hange from Baseline in cognitive performance at Week 48 and Week 96 as measured by the BICAMS
    15. Incidence of adverse events
    16. 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. at Weeks 24 and 48
    2. Up to 96 weeks
    3. Baseline and Week 96
    4. Up to 96 weeks
    5. at Week 96
    6-8. Up to 96 weeks
    9. at Weeks 24, 48 and 96
    10. Baseline and 96
    11. Baseline, Weeks 48, and 96
    12-13. Baseline, Weeks 24, 48, and 96
    14. Baseline, Weeks 48, and 96
    15-16. Up 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 No
    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 No
    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 EEA220
    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
    Belgium
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Ireland
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    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
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In 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: 750
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 750
    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 who completed the study and decided, in agreement with their treating neurologist, to continue on ocrelizumab treatment can either continue on commercial ocrelizumab if available locally and/or be rolled-over in an separate ocrelizumab LTE study.
    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 Decision2016-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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