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    Summary
    EudraCT Number:2010-021978-11
    Sponsor's Protocol Code Number:101MS326
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-10-28
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-021978-11
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS
    A.4.1Sponsor's protocol code number101MS326
    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 Limited
    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 Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Limited
    B.5.2Functional name of contact pointNot available
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailascendspmsstudy@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 Yes
    D.2.1.1.1Trade name Tysabri
    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.3.2Product code AN100226, BG00002
    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 INNNATALIZUMAB
    D.3.9.1CAS number 189261-10-7
    D.3.9.3Other descriptive nameSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Secondary Progressive 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 18.0
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive 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
    Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS.

    Part 2: The primary objective of Part 2 of the study is to evaluate the safety profileof natalizumab in subjects with SPMS.
    E.2.2Secondary objectives of the trial
    The secondary objectives of Part 1 of this study are to determine:
    •the proportion of subjects with consistent improvement in Timed 25-foot Walk (T25FW) •the change in subject-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12) • the change in manual ability based on the ABILHAND Questionnaire •the impact of natalizumab on subject-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical)
    •the change in whole brain brain volume between the end of study and Week 24 using MRI• the proportion of subjects experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores
    The secondary objectives of Part 2 of this study are as follows:
    •to investigate long term disability (based on clinical or patient - reported assessment) in subjects with SPMS receiving natalizumab treatment for approximately 4 years.• to assess change in brain volume and T2 lesion volume
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies are detailed in main protocol , version 2 Final dated 29 June 2011, section 13.5.
    The substudies to be performed in any of the involved countries are as follows:
    - CSF Concentrations of Natalizumab and Inflammatory Markers: US, Canada, UK, Sweden, Denmark, Poland and Germany
    - Cognition: Australia, Canada, Italy, Spain, UK, US
    - Genetic Analysis: in all the countries after patient consent.


    E.3Principal inclusion criteria
    Part 1:To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization (Day 0), or at the timepoint specified in the individual eligibility criterion listed
    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. Be between the ages of 18 and 58, inclusive, at the time of informed consent.
    3. Onset of SPMS at least 2 years prior to enrollment. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by MS relapses (Lublin, Reingold, 1996) ) for at least 2 years.
    4. Have EDSS score of 3.0 to 6.5, inclusive.
    5. Have an MS Severity Score (MSSS) of 4 or higher.
    6. Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment as defined in the Study Reference Guide.
    7. Subjects must have completed those baseline assessments associated with components of the primary endpoint (EDSS, T25FW, 9HPT) prior to randomization (Day 0).
    8. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last infusion.
    Part 2: To be eligible to participate in Part 2 Extension Phase of study, candidates must meet the following eligibility criteria at the time of consent into Part 2 ,or at the timepoint specified in the individual eligibility criterion listed:
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use PHI in accordance with national and local subject privacy regulation.
    2. Subjects must have participated in and completed Part 1, have documented Wk 108 assessment attempts for EDSS,T25FW,and 9HPT prior to first open-label dosing at Week 108 and not have missed 2 or more consecutive infusions in Part 1 of the study.
    3. Subjects of childbearing potential must practice effective contraception during the study and be able to conticue contraception for 3 months after their last infusion.
    E.4Principal exclusion criteria
    Part1:Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of randomization Day 0),or at the timepoint specified in the individual criterion listed
    1.Have a diagnosis of RRMS or PPMS as defined by the revised McDonald Committee criteria. 2.Had a recent clinical relapse (within 3 mos) prior to randomization. 3.Have a T25FW test of >30 secs during the screening period. 4.Any value below the lower limit of normal for blood levels of leukocytes, lymphocytes, or neutrophils. 5.Considered by the Inv.to be immunocompromised based on medical history, physical examination, laboratory testing, or any other testing required by local guidelines, or due to prior immunosuppressive or immunomodulating treatment. 6.Subjects for whom MRI is contraindicated(ie have pacemakers or other contraindicated implanted metal devices or have claustrophobia that cannot be medically managed). 7.History of any clinically significant(as determined by the Inv.)cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic(other than MS), dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical study. 8.History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured). 9.Known history of or positive test result for HIV. 10.Positive test result for HCV or HBV (test for hepatitis B surface antigen and/or hepatitis B core antibody). 11.History of transplantation or any anti-rejection therapy. 12.Presence of any infectious disease (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to screening. 13.History of PML or other opportunistic infections including active tuberculosis. 14.Any prior treatment with cell-depleting therapies, including total lymphoid irradiation, cladribine, rituximab, alemtuzumab, or bone marrow ablation. 15.Any prior treatment with natalizumab. 16.Treatment with mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, T cell or T cell receptor vaccination, fingolimod, daclizumab, or cytapheresis within 6 mos prior to randomization.17.Treatment with IV or oral corticosteroids, IvIg, or plasmapheresis for treatment of MS within the 3 mos prior to randomization. 18.Treatment with glatiramer acetate or any interferon beta preparations within 4 wks prior to randomization. 19.Treatment with 4-aminopyridine within 30 days prior to randomization, unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study. 20.Female subjects considering becoming pregnant while in the study. 21.Female sub. of childbearing potential who have a positive pregnancy test at either the Screen, Visit or Wk 0. 22.Female sub. who are pregnant or currently breastfeeding. 23.History of drug or alcohol abuse, in the opinion of the Investigator, within 2 years prior to entry. 24.Unwillingness or inability to comply with the requirements of this prot., including the presence of any condition (physical, mental,or social) that is likely to affect the subject's ability to comply with the study prot. 25.Participation in any other investigational treatment study within the 3 mos prior to screening or concurrent with this study. 26.Any pre-scheduled elective procedure during the study period that, in the opinion of the Inv.,would interfere with study parameters.27.Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study. 28.Previous participation in this study.
    Part 2:Candidates will be excluded from Part 2 Ext. Ph. if any of following exist at time of consent into Part 2 of study
    1.Subjects with any significant change in clinical status including lab tests that in opinion of Inv. would make them unsuitable to participate in extension study. Inv. must review the subject's medical fitness for participation and consider any diseases that would preclude treatment. 2.Subjects who discontinued study treatment in Part 1 OR have fewer than 20 infusions in Part 1 OR missed 2 more consecutive infusions in Part 1. 3.Considered by Inv. to be immunocompromised based on medical history, physical examination, laboratory testing or any other testing required by local guidelines. 4.Part1 exclusion criteria no 6 5.Part 1 excl. criteria no 7. 6.New onset of drug or alcohol abuse during Part 1 of study. 7.Part 1 excl. criteria no 8. 8.Signs or symptoms of PML. 9.Part 1 excl. criteria no 20. 10.Female subjscts of childbearing potential who have positive pregnancy test at either Wk 96 (serum) or Wk 108 (serum & urine). 11.Part 1 excl.criteria no 22. 12.Part 1 excl.criteria no 24. 13.Part 1 excl.criteria no 26. 14.Part1 excl.criteria no 27
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: The primary endpoint is a binary outcome of confirmed progressors or non-progressors of disability, where progressors are defined as subjects who meet at least one of the
    following criteria:

    • Confirmed progression in EDSS: EDSS score increased from baseline by at least
    1 point if baseline EDSS ≤5.5 or by at least 0.5 points if baseline EDSS ≥6,
    confirmed at a second visit at least 6 months later and at Week 96 (or at the last available study visit for subjects who withdraw from the study early).
    • Confirmed progression in T25FW: Time taken for T25FW increased by at least
    20% of the baseline walk, confirmed at a second visit at least 6 months later and at Week 96 (or at the last available study visit for subjects who withdraw from the study early).
    • Confirmed progression in 9HPT: Time taken for 9HPT increased by at least 20%
    of the time taken at baseline, confirmed at a second visit at least 6 months later and at Week 96 (or at the last available study visit for subjects who withdraw from the study early).
    The progression in 9HPT can occur on either hand, but will have to be confirmed
    on the same hand.
    Part 2: The primary endpoints in Part 2 of the study is the incidence of AEs and SAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: at 6 month intervals
    Part 2: as necessary
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are as follows:
    • Percentage of T25FW responders (defined as any improvement from best pre-dose T25FW in at least 75% of the scheduled on-treatment visits through Week 96).
    • Change from baseline in MSWS-12 score to Week 96.
    • Change from baseline in ABILHAND Questionnaire scores to Week 96.
    • Change from baseline in MSIS-29-Physical score to Week 96.
    • Percentage change from Week 24 in whole brain volume at Week 96.
    • Percentage of subjects experiencing confirmed worsening in the individual EDSS Physical Functional System Scores where confirmed is defined as 2 examinations at least 6 months apart

    Part 2: The secondary endpoints in Part 2 of the study are as follows:
    • Percentage of subjects with disability worsening at each scheduled efficacy visit in Part 2, defined as one ore more of the following:
    ≥ 20% worsening from Part 1 baseline in T25FW,
    ≥ 20% worsening from Part 1 baseline in 9HTPT, or
    worsening from Part 1 baseline in EDSS ( ≥ point increase if Part 1 baseline EDSS ≤ 5.5 or ≥0.5 point increase if Part 1 baseline EDSS > 5.5)
    • Absolute and percentage change in T25FW, 9HPT, and EDSS from Part 1 baseline to each scheduled efficacy visit in Part 2, in all subjects and in subjects with and without disabilityworsening and defined above.
    • Absolute and percentage change in the 6MWT, MSIS-29 Physical, and SDMT, from Part 1 baseline to each scheduled efficacy visit in Part 2.
    • Absolute and percentage change in the WPAI-MS Questionnaire over the Extension Phase, from Part 2 baseline to each scheduled efficacy visit in Part 2.
    • Percentage change in whole brain volume from Part 1 baseline to each scheduled efficacy visit in Part 2.
    • Percentage change in gray matter brain volume from Part 1 baseline to each scheduled efficacy visit in Part 2.
    • Absolute and percentage change in number of new/enlarging T2 leasions from Part 1 baseline to each scheduled efficacy visit in Part 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1:
    • % T25FW responders (every 3 months)
    • Change from baseline in MSWS-12 score to Week 96 (every 3 months)
    • Change from baseline in ABILHAND Questionnaire scores to Week 96 (every 3 months)
    • Change from baseline in MSIS-29-Physical score to Week 96 (every 6 months)
    • % change from Week 24 in whole brain volume at Week 96 (every 6 months)

    • % subjects experiencing confirmed worsening in the individual EDSS Physical Functional System Scores where confirmed is defined as 2 examinations at least 6 months apart (6months intervals)
    Part 2: T25FW, 9HPT, EDSS, 6MWT, MSIS-29 Physical, WPAI-MS, and brain MRI assessment will be taken annually (every 48 weeks) and SDMT will be taken every 4 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 No
    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 No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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
    Optional Open-Label Extension
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA126
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Ireland
    Israel
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    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
    The end of study is last subject, last visit for final collection of data.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    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: 856
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 506
    F.4.2.2In the whole clinical trial 856
    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 who are not enrolling into Part 2 of the study are to return to the study site for a follow-up visit 12 weeks after the last dose of study treatment (Week 108). Subjects who enroll in Part 2 are to return to the study site for a follow-up visit 12 weeks after the last dose of study treatment (Week 216, or later, if commercial product not yest available).
    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 Decision2011-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-21
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