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    Summary
    EudraCT Number:2012-005086-12
    Sponsor's Protocol Code Number:GAM-27
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-18
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-005086-12
    A.3Full title of the trial
    Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis.
    Aktív kontrollos Fázis IIIb vizsgálat arra, hogy a HAP pontozási rendszer képes-e megjósolni, hogy a korai, relapszáló szklerózis multiplexben szenvedő betegek közül ki fog az Octagam 5% terápiára válaszreakciót mutatni
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin
    Vizsgálat arra, hogy a HAP pontozási rendszer képes-e megjósolni, hogy a korai, relapszáló szklerózis multiplexben szenvedő betegek közül ki fog az Octagam 5% terápiára válaszreakciót mutatni
    A.3.2Name or abbreviated title of the trial where available
    PREDICT trial
    A.4.1Sponsor's protocol code numberGAM-27
    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 SponsorOctapharma AG
    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 supportOctapharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOctapharma Pharmazeutika Produktionsgesellschaft m.b. H.
    B.5.2Functional name of contact pointClinical Research Department
    B.5.3 Address:
    B.5.3.1Street AddressOberlaaerstr. 235
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1100
    B.5.3.4CountryAustria
    B.5.4Telephone number+43161032 1295
    B.5.5Fax number+43161032 9249
    B.5.6E-mailclinical.department@octapharma.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 Octagam 50 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma Pharmazeutika Produktionsges.m.b.H.
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.4Pharmaceutical form 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 INNHuman normal immunoglobulin
    D.3.9.1CAS number 308067-58-5
    D.3.9.2Current sponsor codeOctagam 5%
    D.3.9.3Other descriptive nameIMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB20618
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Copaxone 20 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.3Other 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 number20
    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 No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Rebif 44 micrograms
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    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 nameRebif 44 micrograms
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNINTERFERON BETA-1a
    D.3.9.1CAS number 145258-61-3
    D.3.9.4EV Substance CodeSUB02709MIG
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Betaferon 250 microgram/ml
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameBetaferon 250 microgram/ml
    D.3.4Pharmaceutical form Powder and solvent for 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 INNINTERFERON BETA-1b
    D.3.9.1CAS number 145155-23-3
    D.3.9.4EV Substance CodeSUB02709MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Extavia 250 microgram/ml
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    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 nameExtavia 250 microgram/ml
    D.3.4Pharmaceutical form Powder and solvent for 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 INNINTERFERON BETA-1a
    D.3.9.1CAS number 145155-23-3
    D.3.9.4EV Substance CodeSUB02709MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    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 multiple sclerosis
    relapszáló szklerozis multiplex
    E.1.1.1Medical condition in easily understood language
    Relapsing-remitting (RR) multiple sclerosis (MS) is the most common chronic inflammatory disease of the central nervous system (CNS) leading to demyelination and axonal loss.
    relapszáló-remittáló szklerozis multiplex krónikus, a központi idegrendszer fehérállományának gyulladásos betegsége, melynek következtében károsodnak az idegsejtek és az idegsejteket körülvevő myelin.
    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 17.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the ability of the HAP score to accurately predict responders to Octagam 5%
    Megvizsgálni, hogy a HAP pontozás mennyire pontosan képes előre jelezni, hogy melyik betegeknél alakul ki válaszreakció az Octagam 5%-ra
    E.2.2Secondary objectives of the trial
    • To verify that Octagam 5% in predicted responders is of at least similar effectiveness as the first-line therapies IFN-β sc or GA • To verify that the HAP score result is of no predictive power for the ARR in IFN-β sc or GA treated patients • To evaluate the assumption that the HAP score truly predicts the effectiveness of treatment with Octagam 5% and not the progress of disease as such • To investigate the proportion of patients responding to IMP treatment vs. patients not responding • To investigate the effect of IMP treatment on the time to first medically confirmed relapse after 3-month run-in phase • To investigate the effect of IMP treatment on the level of disability, evaluated by means of the EDSS and the MSFC score • To investigate the effect of IMP treatment on the brain by means of MRI parameters (lesion number and volume; whole brain volume) • To investigate the effect of IMP treatment on health-related QoL • To investigate the safety and tolerability of IMP treatment
    Igazolni
    • az Octagam 5% az előrejelzés szerint válaszreakciót adó betegek esetében legalább annyira hatékony, mint az első vonalban alkalmazott IFN-ß sc vagy GA terápia
    • a HAP pontozás eredménye nem bír előrejelző erővel az annualizált kiújulási rátára vonatkozóan
    • Kiértékelni a feltételezést, amely szerint a HAP pontozás valóban az Octagam 5% kezelés hatékonyságát jelzi előre, és nem a betegség előrehaladását.
    Megvizsgálni,
    • azok a betegek, akik válaszreakciót adnak bármely vizsgálati gyógyszerkészítménnyel végzett kezelésre, milyen arányban viszonyulnak azokhoz a betegekhez, akiknél nem alakul ki válaszreakció
    • milyen hatással van az IMP kezelés az első klinikailag igazolt relapszusig eltelt idő hosszára a 3 hónapos bevezető fázist követőenMegvizsgálni, hogy milyen hatással van az IMP kezelés az akadályoztatottság szintjére
    • az IMP kezelés milyen hatással van az agyra
    • az IMP kezelés milyen hatással van az életminőségre
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients aged ≥18 years
    2) Early diagnosed relapsing form of MS (≤ 5years) according to the revised McDonald criteria (1-3)
    3) Patients who are at least 3 months on stable dosage of either IFN-β sc or GA and who did NOT receive the other first-line therapy before
    4) Kurtzke’s EDSS ≤3.5
    5) Patients who experienced at least one medically confirmed relapse during the last 12 months or at least two such relapses in the last 24 months prior to study entry (but not within 30 days between last steroid treatment of relapse and start of screening;
    subjects who relapse during the screening phase can be re-screened, once the relapse has resolved but earliest 30 days after the end of relapse treatment with steroids) or at least 1 T1 Gd+ lesion at screening
    6) Voluntarily given, fully informed written consent obtained from patient before any study-related procedures are conducted
    7) Patient must be capable to understand and comply with the relevant aspects of the study protocol.
    • A beteg életkora 18 év
    • Korai stádiumban diagnosztizált kiújuló típusú SM (≤ 5 év) a módosított McDonald kritériumok szerint (1-3)
    • A beteg legalább 3 hónapja stabil dózisú kezelést kap vagy IFN-ß sc-vel vagy GA-val, és a másik első vonalbeli kezelést eddig NEM kapta
    • Kurtzke EDSS 3.5
    • A beteg legalább egy orvosilag igazolt relapszust tapasztalt a vizsgálat megkezdését megelőző 12 hónapon belül, vagy legalább 2 ilyen relapszusa volt a vizsgálat megkezdését megelőző 24 hónapon belül (de nem volt relapszusa a relapszus kezelésére adott legutóbbi szteroid kezelés és a szűrővizsgálat között eltelt 30 napon belül; azok a betegek, akiknél relapszus jelentkezik a szűrési fázison belül, a relapszus megszűnését követően újraszűrhetőek, de legkorábban 30 nappal a relapszus kezelésére adott szteroid terápia befejezése után) vagy legalább 1 T1 Gd+ léziója van a szűrővizsgálat idején
    • A vizsgálathoz kapcsolódó eljárások bármelyikének megkezdése előtt be kell szerezni a beteg teljes tájékoztatáson alapuló, önkéntes, írásos beleegyezését
    • A betegnek képesnek kell lennie megérteni a vizsgálati terv rávonatkozó aspektusait, és képesnek kell lennie megfelelni azoknak.
    E.4Principal exclusion criteria
    1) Patients who have received treatment with immunoglobulins for any reason in the last 6 months
    2) Patients who have received immunosuppressive treatments (azathioprine,
    mitoxantrone, cyclophosphamide,teriflunomide or fingolimod in the last 6 months.
    3) Patients who have received rituximab or other immune cell depleting therapies in the last 18 months
    4) Treatment with steroids (oral or parenteral, long-term, i.e. 30 days or more, not intermittent or burst, daily, ≥0.15 mg of prednisone or equivalent/kg/day ) except relapse treatment with corticosteroids
    5) Patients who have received monoclonal antibody therapy with natalizumab in the last 12 months
    6) Patients who have ever received monoclonal antibody therapies with alemtuzumab, daclizumab, or ocrelizumab
    7) Patients with severe renal function impairment as defined by serum creatinine values >120 μmol/L
    8) Patients with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the patient has antibodies against IgA
    8)Patients with a history of deep vein thrombosis or thrombotic complications of IVIG therapy
    9) Patients with a body weight of ≥120 kg
    10) Patients with a history of anaphylaxis after previous transfusions of blood or blood products
    11) Patients for whom MRI is contraindicated or who are allergic to gadolinium
    12)Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner) while on study
    13) Patients with a diagnosis of significant depression
    14) Patients with known chronic infectious diseases (e.g. hepatitis B or C, HIV, syphilis, tuberculosis) or malignant disease
    15) Patients with known antibody deficiencies or other autoimmune diseases other than MS
    16) Patients participating in another study during the course of this study or during the past 3 months or who have ever participated in a study investigating new diseasemodifying or immunosuppressive drugs
    17) Patients who are institutionalised or kept in detention.
    • A beteg bármilyen okból immunoglobulin kezelést kapott az elmúlt 6 hónapon belül
    • A beteg bármilyen okból immunszupresszív (pl. azatioprin, mitoxantron, ciklofoszfamid,teriflunomide vagy fingolimod) kezelést kapott az elmúlt 6 hónapban
    •Azok a betegek, akik az elmúlt 18 hónapban rituximabot, vagy más, immunsejt depléciós terápiát kaptak.
    • A beteg szteroid kezelést kapott (szájon át, vagy parenterálisan; hosszú ideig, vagyis legalább 30 napon keresztül, tehát nem szakaszosan, vagy csak néhány napig alkalmazott magas dózisban; naponta; ≥0.15 mg prednizon vagy vele ekvivalens készítmény/kg/nap) kivéve, ha relapszus kezelésére alkalmazott kortikoszteroidot kapott
    • A beteg monoklonális antitest terápiában részesült natalizumabbal az elmúlt 12 hónapban
    • A beteg a kórtörténetében korábban bármikor monoklonális antitest terápiát kapott alemtuzumabbal, daclizumabbal vagy ocrelizumabbal
    • A betegnek súlyos veseelégtelensége van, amelyet >120μmol/L szérum kreatinin szint jelez
    Ismert, hogy a beteg nem tolerálja a homológ immunoglobulinokat, különös tekintettel az immunoglobulin A (IgA) deficienciára, vagyis ha a beteg antitesteket termel az IgA ellen
    •A beteg kórtörténetében mélyvénás trombózis szerepel, vagy az IVIG terápia hatására trombotikus szövődmény alakult ki
    • A beteg testtömege 120 kg
    • A beteg kórtörténetében szerepel korábbi vérátömlesztéskor, vagy más vérkészítmény adásakor jelentkező anafilaxia
    • A beteg esetében ellenjavallott az MRI vizsgálat, vagy a beteg allergiás a gadolíniumra
    • Nőbeteg, aki szoptat, terhes vagy tervezi, hogy teherbe fog esni, vagy nem hajlandó hatékony fogamzásgátló módszert alkalmazni (például implantátum, injekció, kombinált orális fogamzásgátlók, méhen belüli eszközök (IUD), szexuális önmegtartóztatás, vagy vazektómián átesett férfi partner) a vizsgálatban való részvétel alatt
    • A betegnél jelentős depressziót diagnosztizálnak
    • Ismert, hogy a betegnek krónikus fertőző betegsége (pl. hepatitisz B vagy C, HIV, szifilisz, tuberkulózis) vagy rosszindulatú betegsége van
    • Ismert, hogy a betegnek antitest deficienciája, vagy az SM-től eltérő bármilyen autoimmun betegsége van
    • A beteg az elmúlt 3 hónapban részt vett egy másik klinikai vizsgálatban, vagy korábban bármikor részt vett olyan klinikai vizsgálatban, amelyet új betegségmódosító, vagy immunoszuppresszáns készítményekkel végeztek
    • A beteg tartós bentlakásos ellátásban részesül, vagy őrizetben van.
    E.5 End points
    E.5.1Primary end point(s)
    Superiority with regard to decreased ARR of Octagam 5% treatment in patients pre-classified as predicted responders (“RO”) compared to predicted nonresponders (“NRO”) to Octagam 5% treatment
    Az Octagam 5% kezelés fölénye a csökkentett ARR (Annualized Relapse Rate) tekintetében az előre jelzett válaszadóként („RO”) elő-osztályozott betegekben, összehasonlítva az Octagam 5% kezelésre előre jelzett nem-válaszadó („NRO”) betegekkel
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously
    Folyamatosan
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are:
    • ARR of Octagam 5% treatment compared to active control (first-line therapy: IFN-β sc or GA)
    • ARR of IFN-β sc or GA treatment compared between predicted responders (“RI/G”) and non-responders (“NRI/G”) to Octagam 5% treatment
    • Compare ARR of “RO” with both IMP treatment arms combined (“RI/G” and “NRI/G”)
    • Percentage of responders and non-responders in the 21-month period between 3 months after first study treatment administration (“run-in” phase) and the end of treatment period at month 24)
    • Time from randomisation to first medically confirmed relapse after 3-month run-in phase
    • Time from last relapse before enrolment to first medically confirmed relapse after 3-month run-in phase
    • Progression of the disease (defined as an increase of the EDSS), confirmed at 2 separate assessments at least 12 weeks apart
    • Change in MSFC
    • Cerebral MRI assessments: number and volumes of Gadolinium-diethylenetriamine penta-acetic acid (Gd-DTPA) enhancing lesions with T1 weighted imaging; number of new and enlarging T2 lesions; number of new T1 Black Holes; volumes of T1 and T2 lesions; whole brain volume
    • Health-related Quality of Life assessed by MSQOL-54
    Secondary safety endpoints are:
    • Adverse event (AE) monitoring
    • Vital signs (blood pressure, heart rate, body temperature and respiratory rate)
    • Standard laboratory safety tests (clinical chemistry and haematology)
    •ARR az Octagam 5% kezelés esetén, összehasonlítva az aktív kontrollal (első vonalbeli terápia: IFN-ß sc vagy GA)
    •ARR összehasonlítása IFN-ß vagy GA kezelés esetén az Octagam 5% kezelésre előre jelzett válaszadók („RI/G”) és előre jelzett nem-válaszadók („NRI/G”) között
    •A „RO” ARR-jének összehasonlítása mindkét kombinált IMP karon („RI/G” és „NRI/G”)
    •Valós válaszadók és nem-válaszadók százalékos eloszlása az első dózis beadását követő 3 hónapos időszak („bevezető” fázis) vége és a kezelési időszak vége (24. hónap) közé eső 21 hónapos időszakban
    •A randomizálás és a 3 hónapos bevezető fázis utáni első orvosilag igazolt relapszus között eltelt idő
    •A bevonás előtt utolsó relapszus és a 3 hónapos bevezető fázis utáni első orvosilag igazolt relapszus között eltelt idő
    •A betegség progressziója (amelyet az EDSS növekedéseként határozunk meg) kettő különálló, legalább 12 hét különbséggel elvégzett felméréssel igazolva
    •MSFC változása
    •Agyi MRI felmérés: Gadolínium-dietilén-triamino-pentaecetsav (Gd-DTPA) dúsulással járó léziók száma és mérete T1 súlyozott képalkotással, új és növekvő T2-t léziók száma, új T1 Black Hole léziók száma, T1 és T2 léziók méretei, teljes agytérfogat
    •Egészségi állapothoz kapcsolódó életminőség
    Másodlagos biztonságossági végpontok:
    •Nemkívánatos események (Adverse event (AE)) monitorozása
    •Életfunkciós jelek (vérnyomás, szívritmus, testhőmérséklet és légzésszám
    •Sztenderd laboratóriumi biztonságossági vizsgálatok (klinikai kémia és hematológia)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously
    Folyamatosan
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    rater-blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Austria
    Bulgaria
    Germany
    Hungary
    Poland
    Russian Federation
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 211
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 216
    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)
    After end of study the patient will receive the most suitable therapy currently available for his/her condition.
    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 Decision2013-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-15
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