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    The EU Clinical Trials Register currently displays   42585   clinical trials with a EudraCT protocol, of which   7011   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-016824-29
    Sponsor's Protocol Code Number:1232009
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-016824-29
    A.3Full title of the trial
    REsPons på interferon-Alfa hos InterfeRon-β-neutraliserende antistof-positive patienter med multipel sklerose
    A.3.2Name or abbreviated title of the trial where available
    REPAIR
    A.4.1Sponsor's protocol code number1232009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDansk Multipel Sclerose Center
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Multiferon
    D.2.1.1.2Name of the Marketing Authorisation holderSWEDISH ORPHAN INTERNATIONAL AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNHUMAN LEUCOCYTE INTERFERON-ALPHA
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor codeSWEDISH ORPHAN INTERNATIONAL
    D.3.9.3Other descriptive nameHUMAN LEUCOCYTE INTERFERON-ALPHA
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6000000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Rebif
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 220581-49-7
    D.3.9.2Current sponsor codeMerck Serono
    D.3.9.3Other descriptive nameINTERFERON BETA-1A
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number22 to 44
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Betaferon
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeBayer
    D.3.9.3Other descriptive nameINTERFERON BETA-1B
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8000000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Formål med forsøget er at undersøge, om patienter med MS, som har udviklet neutraliserende antistoffer under behandling med interferon-beta og som følge heraf har mistet det biologiske respons på interferon-beta målt ved mRNA MxA, kan opnå et fuldt mRNA MxA respons efter injektion med interferon-alpha (Multiferon). Et fuldt biologisk respons på interferon-alpha vil medføre, at patienterne vil kunne fortsætte behandlingen med et type I interferon i form af interferon-alpha i stedet for at skifte til en anden klasse af medicin mod MS.
    E.2.2Secondary objectives of the trial
    De sekundære formål er at undersøge:
    In vivo-responset på IFN-α af fire andre kendte IFN--responsmarkører: interleukin-10 (IL10), tumornekrosefaktor-relateret apoptoseinducerende ligand (TRAIL), IFN-α-inducerbart protein 27 (IFI27) og kemokinet CXCL10 på mRNA-niveau.
    Ændringen i NAb-koncentration efter en injektion med IFN-α sammenlignet med NAb-koncentrationen ved baselinebesøget.
    Gen-induktion på Affymetrix-chips efter en injektion med IFN-α sammenlignet med en tidligere undersøgt gen-induktion på Affymetrix-chips efter en injektion med IFN-β i en kontrolgruppe bestående af NAb-negative MS-patienter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Forsøgspersonen skal have afgivet et skriftligt, informeret samtykke før nogen forsøgsrelaterede aktiviteter.
    Forsøgspersonen skal være i alderen 18-55 år (inklusive).
    Forsøgspersonen skal have MS i henhold til McDonalds kriterier.
    Forsøgspersonen skal have neurologisk status svarende 5,5 eller herunder på EDSS skalaen.
    Forsøgspersonen skal have været behandlet med et IFN-β-præparat i mindst 12 måneder på et eller andet tidspunkt.
    Forsøgspersonen skal have vist sig at være NAb-positiv og uden noget in vivo mRNA MxA-respons inden for de sidste 12 måneder.
    Forsøgspersonen skal være forberedt og skal anses for at være i stand til at følge protokollen.
    E.4Principal exclusion criteria
    Forsøgspersonen må ikke lide af sygdomme, der kan give symptomer, der minder om MS.
    Forsøgspersonen må ikke have fået glatiramer acetat i 3 måneder før screeningsbesøget.
    Forsøgspersonen må ikke have fået immunmodulerende eller immunsuppressiv behandling (bortset fra IFN-β eller glatiramer acetat) i 6 måneder før screeningsbesøget.
    Forsøgspersonen må ikke have fået mitoxantron, cyclofosfamid, treosulfan, natalizumab, daclizumab, rituximab, alemtuzumab, cladribin eller nogen anden eksperimentel behandling på noget tidspunkt.
    Forsøgspersonen må ikke tidligere have fået foretaget en strålebehandling af hele kroppen, strålebehandling af hele lymfesystemet, stamcellebehandling, autolog knoglemarvstransplantation eller allogen knoglemarvstransplantation.
    Forsøgspersonen må ikke være blevet behandlet med glukokortikoider eller ATCH senere end 2 måneder før screeningsbesøget.
    Forsøgspersonen må ikke være afhængig af alkohol eller stoffer.
    Forsøgspersonen må ikke lide af hjerteinsufficiens eller nyreinsufficiens.
    Forsøgspersonen må ikke lide af en systemisk sygdom, der kan have indflydelse på forsøgspersonens sikkerhed eller behandlingscompliance.
    Forsøgspersonerne kan være mænd eller kvinder. Kvinder i den fødedygtige alder skal være seksuelt inaktive eller anvende en medicinsk acceptabel præventionsmetode. Acceptable metoder omfatter p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion). I visse tilfælde kan steril fast partner eller en dobbeltbarrieremetode (kondom eller spiral med sæddræbende creme) findes acceptabelt.Der foretages graviditetstest ved screeningsbesøget).
    Forsøgspersonen må ikke have en kendt eller formodet allergi over for IFN-α.
    Forsøgspersonen må ikke have deltaget i noget andet forsøg i 3 måneder før screeningsbesøget.
    E.5 End points
    E.5.1Primary end point(s)
    In vivo mRNA MxA-respons efter en injektion med IFN-α sammenlignet med in vivo mRNA MxA-responset efter en injektion med IFN-β efter besøget ved screenings-/baselinebesøget.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    Forsøget slutter med sidste besøg af den sidste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years0
    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.1.3Elderly (>=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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 Decision2010-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-07
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