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    Summary
    EudraCT Number:2021-006107-15
    Sponsor's Protocol Code Number:21-PP-23
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-006107-15
    A.3Full title of the trial
    LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB IN FRENCH PATIENTS WITH PROGRESSIVE MS:
    CONSONANCE EXTENSION STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB IN FRENCH PATIENTS WITH PROGRESSIVE MS:
    CONSONANCE EXTENSION STUDY
    A.3.2Name or abbreviated title of the trial where available
    CONSONANCE EXTENSION STUDY
    A.4.1Sponsor's protocol code number21-PP-23
    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 SponsorUniversity Nice Hospital
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportROCHE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Nice Hospital
    B.5.2Functional name of contact pointreseach project manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI- Hôpital de Cimiez - 4 avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06000
    B.5.3.4CountryFrance
    B.5.4Telephone number33492034588
    B.5.5Fax number33492034075
    B.5.6E-mailbonnard.m@chu-nice.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OCREVUS
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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
    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.3.11 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 typehumanized monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    progressive multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    progressive multiple sclerosis
    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 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
    The primary objective of this study is to evaluate the effectiveness of ocrelizumab on upper extremity disability progression.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the long-term effectiveness of ocrelizumab (including preventing or delaying the time to significant disability outcomes) in patients with progressive MS who have completed CONSONANCE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent form (ICF)
    • Able to comply with the study protocol, in the investigator’s judgment
    • Affiliation to the social security system
    • Completed the treatment period of Roche-sponsored ocrelizumab trial (CONSONANCE) and who in the opinion of the investigator may benefit from treatment with ocrelizumab. Only patients enrolled under Protocol version 1 (approval date: 18 February 2018) will be eligible.
    • Meet re-treatment criteria with ocrelizumab (please see section 6.11)
    • Patients who became pregnant by chance between the last visit of the CONSONANCE study and screening of this study, as confirmed by pregnancy tests at screening, will enter the study but will only re-start treatment with ocrelizumab after birth or after breastfeeding is stopped, as per re-treatment criteria in section 6.11
    • Women of childbearing potential* (WOCBP):
    o Must have a negative urine pregnancy test at Visit 1 (Screening) and Visit 2 (Baseline)
    o Must agree to remain abstinent or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:
    • Hypersensitivity to ocrelizumab or any of its excipients
    • Patients in a severely immunocompromised state, until the condition resolves
    • Evidence of any AE potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation
    • Existence of a contra-indication as per the SmPC
    • Prohibited concomitant medication as specified in section 6.7
    • Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug in CONSONANCE
    • Patients who had early ocrelizumab discontinuation in CONSONANCE (exemption made for treatment discontinuation due to unplanned pregnancy and breastfeeding for patients who continued clinical study assessments in CONSONANCE)
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective will be measured on upper limbs, based the following endpoint: proportion of patients with upper limb disability progression, defined as the proportion of patients with ≥20% worsening in 9-HPT score confirmed for at least 24 weeks, from baseline to Week 192.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to Week 192.
    E.5.2Secondary end point(s)
    The secondary objectives will be measured:
    The proportion of patients reaching confirmed EDSS ≥7.0 (i.e., requiring the use of a wheelchair) between baseline and Week 192, for patients with a baseline EDSS <7.0
    • The proportion of patients reaching confirmed EDSS ≥6.0 (i.e., requiring a walking aid to walk about 100 m with or without resting) between baseline and Week 192, for patients with a baseline EDSS <6.0
    • The proportion of patients with 24-week CDP in EDSS, defined as an increase in EDSS score that is confirmed for at least 24 weeks (an increase of 1.0 point from baseline EDSS in patients with a baseline EDSS score  5.5 or an increase of  0.5 point in patients with a baseline EDSS score of 5.5)
    • The proportion of patients with ≥20% worsening in 25FWT score confirmed for at least 24 weeks, from baseline to Week 192, in patients who are ambulatory at baseline
    • The proportion of relapse*-free patients by Week 192
    • The proportion of patients with T1 gadolinium-enhancing lesions as detected by brain magnetic resonance imaging (MRI) at Weeks 48, 96, 144 and 192
    • The proportion of patients with new, and/or enlarging T2 hyperintense lesions as detected by brain MRI at Weeks 48, 96, 144 and 192
    • The proportion of patients with NEP defined as no progression sustained for at least 24 weeks on all of the following three components (EDSS; ≥20% increase in 25FWT; ≥20% increase in 9-HPT) from baseline to Week 192
    • The proportion of patients with NEPAD defined as no progression sustained for at least 24 weeks on all of the three components of NEP (EDSS, 25FWT, 9-HPT), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium-enhancing lesion from baseline to Week 192
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 No
    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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 90
    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 state90
    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)
    NONE
    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 Decision2022-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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