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    Summary
    EudraCT Number:2011-005550-57
    Sponsor's Protocol Code Number:GA-MS-302
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-09
    Trial results View 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 ConcernedGreece - EOF
    A.2EudraCT number2011-005550-57
    A.3Full title of the trial
    A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).
    A.3.2Name or abbreviated title of the trial where available
    GLOW study
    A.4.1Sponsor's protocol code numberGA-MS-302
    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 SponsorTeva Pharmaceutical Industries Ltd.
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street Address7, Waldecker Str.
    B.5.3.2Town/ cityMörfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number00000
    B.5.5Fax number00000
    B.5.6E-mailinfo.era-clinical@teva.de
    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 name20mg/0.5ml glatiramer acetate
    D.3.2Product code 20mg/0.5ml GA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNglatiramer acetate
    D.3.9.1CAS number 147245-92-9
    D.3.9.2Current sponsor code20 mg/0.5 ml GA
    D.3.9.3Other descriptive nameglatiramer acetate
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 Yes
    D.3.11.13.1Other medicinal product typeimmunomodulating agent
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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 (RRMS)
    E.1.1.1Medical condition in easily understood language
    Relapsing-remitting multiple sclerosis is a form of multiple sclerosis. Patients tend to experience an attack or series of attacks (relapse), followed by complete or partial recovery (remission).
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 assess the effect of Glatiramer Acetate (GA) injection 20 mg/0.5 ml administered daily compared to placebo in subjects with RRMS on the total number of confirmed relapses during the 12 month PC phase. This will be used to calculate the Annualized Relapse Rate during the PC phase per each arm.
    E.2.2Secondary objectives of the trial
    To assess the effect of GA injection 20 mg/0.5ml administered daily compared to placebo in subjects with RRMS:
    - on the cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (end of PC phase).
    - on the cumulative number of Gd-enhancing lesions on T1-weighted images measured at Months 6 and 12 (end of PC phase).
    - on the development of brain atrophy as defined by the percent brain volume change from baseline to Month 12 (end of PC phase).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    •Blood samples for Pharmacogenetic (PGx) analysis will be collected from all subjects who signed the appropriate informed consent form, pending Ethic Committees approval, during the PC phase, preferably at Month 0 (baseline) or any other visit following Month 0.
    E.3Principal inclusion criteria
    1.Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with a relapsing-remitting disease course.
    2.Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
    3.Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment or ACTH, 30 days prior to screening (Month -1) and between screening and baseline (Month 0) visits.
    4.Subjects must have experienced one of the following:
    • At least one documented relapse in the 12 months prior to screening, or
    • At least two documented relapses in the 24 months prior to screening, or
    • One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
    5.Subjects must be between 18 and 55 years of age, inclusive.
    6.Women of child-bearing potential must practice an acceptable method of birth control.
    7.Subjects must be able to sign and date a written informed consent prior to entering the study.
    8.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
    E.4Principal exclusion criteria
    1. Subjects with progressive forms of MS.
    2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
    3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
    4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
    5. Use of cladribine within 2 years prior to screening.
    6. Previous treatment with immunomodulators within 2 months prior to screening.
    7. Previous use of GA or any other glatiramoid.
    8. Chronic systemic corticosteroid treatment within 6 months prior to screening visit.
    9. Previous total body irradiation or total lymphoid irradiation.
    10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
    11. Pregnancy or breastfeeding.
    12. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
    13. A known history of sensitivity to Gadolinium.
    14. GFR ≤ 60 mL/min/ 1.73m2 at the screening visit
    15. Inability to successfully undergo MRI scanning.
    16. A known drug hypersensitivity to Mannitol.
    17. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
    E.5 End points
    E.5.1Primary end point(s)
    The total number of confirmed relapses during the 12 months PC phase. This will be used to calculate the Annual Relapse Rate during the PC phase per each arm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Relapses will be confirmed/monitored throughout the study.
    E.5.2Secondary end point(s)
    - cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (End of the PC phase)
    - cumulative number of Gd-enhancing lesions on T1-weighted images measured at Month
    - percent brain volume change from baseline to Month 12 (end of PC phase).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following GFR evaluation, all subjects will undergo MRI scans at months 0 (13-7 days prior to baseline visit), Month 6 and Month 12 (end of PC phase) or ET. During an unscheduled visit the investigator will decide if an MRI scan is required.
    - The cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (end of PC phase).
    - The cumulative number of Gd-enhancing lesions on T1-weighted images measured at Months 6 and 12 (End of the PC phase).
    -The percent brain volume change from baseline to Month 12 (end of PC phase).
    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 Yes
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Albania
    Belarus
    Bosnia and Herzegovina
    Bulgaria
    Croatia
    Estonia
    Georgia
    Greece
    Latvia
    Lithuania
    Macedonia, the former Yugoslav Republic of
    Mexico
    Moldova, Republic of
    Montenegro
    Poland
    Romania
    Russian Federation
    Serbia
    Ukraine
    United States
    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
    Last visit of last subject.
    Open Label (OL) Extension: Subjects completing the PC phase or subjects that experienced two confirmed MS relapses during the PC phase will be offered the opportunity to enter into an OL extension phase, in which all subjects will be treated with GA 20 mg/0.5 ml administered daily by SC injection for additional 24 months or until the development of this formulation is stopped by the Sponsor (whichever is sooner).
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 1400
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 790
    F.4.2.2In the whole clinical trial 1400
    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)
    Subjects completing the PC phase will be offered the opportunity to enter into an OL extension phase, in which all subjects will be treated with GA 20 mg/0.5 ml administered daily by SC injection for additional 24 months or until the development of this formulation is stopped by the Sponsor (whichever is sooner).
    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 Decision2012-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-08-06
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