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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-012500-11
    Sponsor's Protocol Code Number:205MS301
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-012500-11
    A.3Full title of the trial
    Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon β 1a) in Patients with Relapsing-Remitting Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    DECIDE
    A.4.1Sponsor's protocol code number205MS301
    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 SponsorBiogen Idec Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road,
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-maildecidestudy@biogenidec.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 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 nameDACLIZUMAB HYP
    D.3.2Product code BIIB019
    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 INNDaclizumab HYP
    D.3.9.2Current sponsor codeBIIB019
    D.3.9.3Other descriptive nameDaclizumab HYP (DAC HYP)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 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 AVONEX
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGEN IDEC
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERON BETA-1A
    D.3.9.3Other descriptive nameINTERFERON BETA-1A
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    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
    D.8 Placebo: 2
    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 placeboIntramuscular 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
    E.1.1.1Medical condition in easily understood language
    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 16.0
    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
    The primary study objective is to test the superiority of DAC HYP compared to IFN β-1a in preventing MS relapse in subjects with relapsing remitting MS (RRMS).
    E.2.2Secondary objectives of the trial
    The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this subject population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for this study, candidates must meet the following eligibility criteria prior to randomization or at the timepoint specified in the individual criteria listed below:
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Must be 18 to 55 years of age, inclusive, at the time of consent.
    3. Must have a confirmed diagnosis of RRMS according to McDonald criteria, numbers 1 through 4 (Polman et al, 2005), and a cranial MRI demonstrating lesion(s) consistent with MS (it is not necessary to obtain a current scan if a scan performed previously is available; if a previous scan is not available, then the baseline scan may be used).
    4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
    5. Must meet one of the following disease activity-related criteria:
    a) Two or more clinical relapses within the previous 3 years with at least 1 clinical relapse in the 12 months prior to randomization.
    OR
    b) One or more clinical relapses and 1 or more new MRI lesions (Gd+ and/or T2 hyperintense lesion) within the previous 2 years with at least one of these events in the 12 months prior to randomization. The new MRI lesion must be distinct from one associated with the clinical relapse. The baseline MRI may be used to satisfy this criterion.
    Note: For inclusion purposes, a clinical relapse is defined as neurologic signs and/or symptoms documented in the medical record of at least 24 hours duration that are determined by the Investigator or the Treating Neurologist as consistent with an MS relapse. Time since relapse should be measured from the time of relapse onset. When inclusion is based on a new MRI lesion, activity must be verified by the central MRI reading center.
    6. Women of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
    E.4Principal exclusion criteria
    1.Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). 2.Known intolerance, contraindication to, or history of non compliance with Avonex 30 mcg.3.History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in this study.4.History of severe allergic or anaphylactic reactions.
    5.Known hypersensitivity to study drugs or their excipients.6.History of abnormal laboratory results that are indicative of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease that would preclude administration of DAC HYP or Avonex.7.History of human immunodeficiency virus (HIV) or other immunodeficient conditions.
    8.History of drug or alcohol abuse within the 2 years prior to randomization.9.History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline. 10.History of suicidal ideation or an episode of clinically severe depression within 3 months prior to Day 1. Subjects receiving ongoing antidepressant therapy will not be excluded from the study unless the medication has been increased within the 6 months prior to Baseline.11.An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.12.Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus. 13.Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening.14.Exposure to varicella zoster virus within 21 days before screening.15.Any of the following abnormal blood tests at screening:
    • hemoglobin ≤9.0 g/dL
    • platelets ≤100 x 10^9/L
    • lymphocytes ≤1.0 x 10^9/L
    • neutrophils ≤1.5 x 10^9/L
    • alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma glutamyl-transferase ≥2 times the upper limit of normal (ULN)
    • serum creatinine ≥ULN
    16.Any previous treatment with daclizumab or other anti-CD25 monoclonal antibody.17.Any type of live virus vaccine from 4 weeks before randomization.18.Infection requiring hospitalization or intravenous (IV) antibiotics within 8 weeks before randomization.19.Elective surgery performed from 2 weeks prior to randomization or scheduled through end of the study.
    20.Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization.21.Prior treatment with the any of the following:
    • total lymphoid irradiation• cladribine• T cell or T cell receptor vaccination• any therapeutic monoclonal antibody, except natalizumab 22.Prior treatment with mitoxantrone, cyclophosphamide, fingolimod, or natalizumab within 1 year prior to randomization.23.Prior treatment with any of the following within the 6 months prior to randomization:
    • cyclosporine• azathioprine• methotrexate• mycophenolate mofetil• intravenous immunoglobulin • plasmapheresis or cytapheresis.24.Treatment with any of the following medications within the 30 days prior to randomization:• IV corticosteroid treatment• oral corticosteroid treatment• glatiramer acetate
    25.Initiation of treatment or dose adjustment of commercially-available Fampridine-SR within the last 90 days.Note: Subject who have been on a stable dose of commercially-available Fampridine-SR for longer than 90 days are not excluded. Use of compounded or other formulations of 4 - aminiopyridine is excluded.
    26.For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin:
    •Subjects treated with any of these agents for fewer than 6 months prior to randomization are excluded from the study unless they discontinue the agent(s) prior to randomization.
    •Subjects treated with 2 or more of these agents for more than 6 months prior to randomization are excluded from the study unless they reduce to ≤1 agent prior to randomization.
    •Subjects who have had dose escalations of one of these agents within the 6 months prior to randomization are excluded from the study unless they revert to a previous dose that had been used for at least 6 months prior to randomization, or unless they discontinue the agent prior to randomization.
    27.Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of randomization and are not able to discontinue the agent or change to an alternative medication allowed by the protocol prior to initiation of study treatment. 28/29.Female subjects currently pregnant,breastfeeding or considering becoming pregnant while in the study.30.Previous participation in this study 31.Subjects for whom MRI is contraindicated
    E.5 End points
    E.5.1Primary end point(s)
    • Annualized relapse rate (ARR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Any relapses and time on study that occur up to Week
    144
    E.5.2Secondary end point(s)
    a) Number of new or newly-enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) over 96 weeks
    b) Proportion of subjects with ustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from baseline EDSS ≥1.0 that is sustained for 12 weeks or at least a 1.5-point increase on the EDSS from baseline EDSS =0 that is sustained for 12 weeks
    c) The proportion of subjects who are relapse-free
    d) Proportion of subjects with a ≥7.5 point worsening from the baseline MSIS-29 physical score at 96 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) Weeks 0, 24, 96, (and also 144/early termination)
    b) Screening, weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144/early termination (and also follow up visits 1 and 2, and unscheduled relapse assessment
    c) up to week 144 (end of study visit)
    d) 96 weeks
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA117
    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
    Brazil
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Georgia
    Germany
    Greece
    Hungary
    India
    Ireland
    Israel
    Italy
    Mexico
    Moldova, Republic of
    Poland
    Romania
    Russian Federation
    Serbia
    Slovenia
    Spain
    Sweden
    Switzerland
    Ukraine
    United Kingdom
    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
    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 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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1800
    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 state69
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 994
    F.4.2.2In the whole clinical trial 1800
    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)
    As per protocol
    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 Decision2010-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-05
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