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    Summary
    EudraCT Number:2013-003884-71
    Sponsor's Protocol Code Number:LPS13649
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-30
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2013-003884-71
    A.3Full title of the trial
    A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409)
    Dugoročno praćenje bolesnika s multiplom sklerozom koji su završili sudjelovanje u produženom planu ispitivanja alemtuzumaba (CAMMS03409)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409
    A.3.2Name or abbreviated title of the trial where available
    TOPAZ
    A.4.1Sponsor's protocol code numberLPS13649
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1148-2987
    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 SponsorGenzyme Corporation
    B.1.3.4CountryUnited States
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis Croatia d.o.o.
    B.5.2Functional name of contact pointVukasin Andric
    B.5.3 Address:
    B.5.3.1Street AddressHeinzelova 70/II
    B.5.3.2Town/ cityZagreb
    B.5.3.3Post code10000
    B.5.3.4CountryCroatia
    B.5.4Telephone number0038516003 471
    B.5.5Fax number0038516003 480
    B.5.6E-mailVukasin.Andric@genzyme.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 Yes
    D.2.1.1.1Trade name Lemtrada
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Therapeutics Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 nameLemtrada
    D.3.2Product code GZ402673
    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 INNalemtuzumab
    D.3.9.1CAS number 216503-57-0
    D.3.9.2Current sponsor codeGZ402673
    D.3.9.4EV Substance CodeSUB12459MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typeHumanised 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
    Relapsing-remitting multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    Relapsing-remitting 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 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 evaluate long-term safety of alemtuzumab
    E.2.2Secondary objectives of the trial
    - To evaluate long term efficacy of alemtuzumab
    - To evaluate the safety profile of patients who received other Disease Modifying Treatment's (DMT) following alemtuzumab treatment
    - To evaluate patient-reported Quality of Life (QoL) outcomes and health resource utilization of patients who received alemtuzumab
    - To evaluate as needed re-treatment with alemtuzumab and other DMTs
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    “Exploratory Pharmacogenomics Assessment Substudy", version 1.0, dated 27Feb2018
    A pharmacogenomics (PGx) substudy will be conducted for exploratory analysis of genetic variations predictive of autoimmune conditions, including thyroid and
    immune thrombocytopenia (ITP), related to MS disease and/or the effects of alemtuzumab. For research purposes only and on a voluntary basis, a blood sample will be proposed to approximately 300 ongoing patients in the TOPAZ
    study who have not provided a PGx sample in the previous studies (CAMMS03409, CAMMS223, CAMMS323 and CAMMS324). A blood sample will be collected from consenting patients.
    Objectives of the substudy are as follows:
    • To develop biomarkers predictive of autoimmune conditions including thyroid disorders and immune thrombocytopenia. This will include collection of samples from patients who have not yet developed any auto immune conditions; these samples would be used as controls.
    • To explore efficacy and safety markers through data analysis.
    • To explore genetic variation related to MS disease manifestation through data analysis.
    Sample collection, handling, storage, and analysis will conform to all applicable national guidance and regulations.
    E.3Principal inclusion criteria
    - Patient has completed at least 48 months of the Extension Study CAMMS03409
    - Signed written informed consent form
    E.4Principal exclusion criteria
    - Patient participating in another investigational interventional study
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence, duration, grade/intensity, relationship to study drug, and outcome of the following:
    - Serious Adverse Events (SAEs).
    - Adverse Events (AEs).
    - Infusion-associated reactions (IAR).
    • Incidence, nature, seriousness, grade/intensity, relationship to study drug, and outcome of the following Adverse Events of Special Interest (AESI):
    - Autoimmune mediated conditions including, but not limited to:
    - Immune thrombocytopenic purpura (ITP)
    - Nephropathies including anti-glomerular basement membrane (GBM) disease
    - Cytopenias
    - Thyroid disorders
    - Autoimmune hepatitis
    - Acquired hemophilia A
    - Hemophagocytic lymphohistiocytosis (HLH)
    - Progressive multifocal leukoencephalopathy (PML)
    - Temporally associated* pulmonary alveolar hemorrhage
    - Temporally associated* myocardial ischemia, myocardial infarction
    - Temporally associated* stroke
    - Temporally associated* cervicocephalic arterial dissection
    (*Temporally associated: 1 to 3 days after the last infusion)
    - Serious infections, including serious opportunistic infections. (eg, Listeria infections, CMV, EBV), HPV associated with cervical dysplasia
    - Malignancy
    - Pneumonitis
    • Changes in laboratory parameters.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final analysis at study completion (Up to a maximum of 5.5 years). An annual partial database lock.
    E.5.2Secondary end point(s)
    - Annualized relapse rate (ARR)
    - Proportion of participants relapse free
    - Change over time in Expanded Disability Status Scale (EDSS) scores
    - Change over time in brain imaging findings
    - Change over time in self-reported quality of life (QoL) as assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36) Version 2
    - Change over time in the Functional Assessment of Multiple Sclerosis (FAMS)
    - Change over time in the EuroQoL in 5 Dimensions (EQ-5D)
    - Pharmaco-economic evaluation (Modified Health Resources Utilization Questionnaire (HRUQ) / Health Related Productivity Questionnaire (HRPQ))
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final analysis at study completion (Up to a maximum of 5.5 years). An annual partial database lock.
    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 Yes
    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) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Belgium
    Brazil
    Canada
    Croatia
    Czech Republic
    Denmark
    Germany
    Israel
    Italy
    Mexico
    Netherlands
    Poland
    Russian Federation
    Serbia
    Spain
    Sweden
    Ukraine
    United Kingdom
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 799
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-03-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    In case of treatment, cautionary measures from approved labelling or IB are applied
    F.4 Planned number of subjects to be included
    F.4.1In the member state127
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 399
    F.4.2.2In the whole clinical trial 799
    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 will be followed for 48-months after the last infusion of alemtuzumab received in the current trial setting. If the 48-month period of safety follow-up continues after the study ends, the patient will be followed by their physician in a regular healthcare setting, in line with the local approved Risk Minimization Plan for alemtuzumab, until the 48-month period is completed.
    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 Decision2014-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-15
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