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    Summary
    EudraCT Number:2014-000254-11
    Sponsor's Protocol Code Number:33375
    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:2014-03-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-000254-11
    A.3Full title of the trial
    ROLE OF ENDOTHELIAL INFLAMMATION IN DEMYELINATING DISEASES OF THE CENTRAL NERVOUS SYSTEM
    ROLE OF ENDOTHELIAL INFLAMMATION IN DEMYELINATING DISEASES OF THE CENTRAL NERVOUS SYSTEM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ROLE OF ENDOTHELIAL INFLAMMATION IN DEMYELINATING DISEASES OF THE CENTRAL NERVOUS SYSTEM
    Screening efter biomarkører til vurdering af prognose og respons på behandling ved multiple sclerose
    A.3.2Name or abbreviated title of the trial where available
    TREMEND
    TREMEND
    A.4.1Sponsor's protocol code number33375
    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 SponsorDepartment of Neurology
    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 supportDepartment of Neurology, Odense University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Neurology
    B.5.2Functional name of contact pointMS clinic, prof Illes
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.6E-mailzsolt.illes@rsyd.dk
    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.2.1.2Country 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.3.1Product nameTecfidera
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) 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.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
    Mulple Sclerosis
    Multipel Sklerose
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sklerose
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Screening for a prognostic biomarker regarding MS
    AIM OF THE PHD PROJECT

    The PhD proposal is centered on three main topics:

    1. The examination of biomarkers related to endothelial function/dysfunction in MS with
    special interest on disease progression and fatigue.

    2. The examination of biomarkers related to endothelial function/dysfunction in NMO vs
    RRMS with special interest on differentiating biomarkers.
    E.2.2Secondary objectives of the trial
    AIM OF THE PHD PROJECT

    The PhD proposal is centered on three main topics:

    1. The examination of biomarkers related to endothelial function/dysfunction in MS with
    special interest on disease progression and fatigue.

    2. The examination of biomarkers related to endothelial function/dysfunction in NMO vs
    RRMS with special interest on differentiating biomarkers.

    3. The effect of DMF on endothelial dysfunction and chronic fatigue in MS.
    3. The effect of DMF on endothelial dysfunction and chronic fatigue in MS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at
    the Screening/Baseline Visit:
    Patients with relapsing remitting multiple sclerosis (RRMS) fulfilling the McDonald criteria.
    Treatment-naïve patients and patients treated with first-line disease modifying treatment
    (DMTs);
    Age 18-60 years.
    EDSS 1-5.5.
    Participants must be able to transport self.
    Signed informed consent.
    Inclusion Criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at
    the Screening/Baseline Visit:
    Patients with relapsing remitting multiple sclerosis (RRMS) fulfilling the McDonald criteria.
    Treatment-naïve patients and patients treated with first-line disease modifying treatment
    (DMTs);
    Age 18-60 years.
    EDSS 1-5.5.
    Participants must be able to transport self.
    Signed informed consent.
    E.4Principal exclusion criteria
    Exclusion Criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at the
    Screening/Baseline Visit:
    MS relapse or change in DMT within 60 days.
    Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
    5
    Cancer within five years.
    ALAT above 90 U/l, BASP above 210 U/l, gamma-GT above 230 U/l.
    Pregnancy or lactation.
    Exclusion Criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at the
    Screening/Baseline Visit:
    MS relapse or change in DMT within 60 days.
    Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
    5
    Cancer within five years.
    ALAT above 90 U/l, BASP above 210 U/l, gamma-GT above 230 U/l.
    Pregnancy or lactation.
    E.5 End points
    E.5.1Primary end point(s)
    Finding a prognostic biomarker
    Finding a prognostic biomarker
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 months
    E.5.2Secondary end point(s)
    2.2.1. Primary Endpoint
    The primary endpoint of this study is change from Baseline in the levels of biomarkers reflecting
    endothelial dysfunction in the serum at Month 24 in subjects with RRMS receiving DMF.
    2.2.2. Secondary Objectives
    The secondary objectives of this study are as follows:
    1. Change from Baseline in the levels of biomarkers reflecting endothelial dysfunction in the
    serum at Month 12 in subjects with RRMS receiving DMF.
    3
    2. Change from Baseline in the levels of biomarkers reflecting endothelial dysfunction in the
    CSF at 12 months in subjects with RRMS receiving DMF.
    3. Correlation between serum levels of endothelial biomarkers at Baseline and clinical
    measures of Tecfidera at Months 12 and 24: fatigue, cognition, and function at these
    timepoints, and relapse rate in the last 2 years before enrolment.
    4. The predictive role of serum levels of endothelial biomarkers measured at Baseline on the
    clinical efficacy of Tecfidera at Months 12 and 24: fatigue, function, relapse rate, and
    cognition.
    5. Correlation between CSF levels of endothelial biomarkers at Baseline and clinical measures
    of Tecfidera at Months 12: fatigue, cognition, and function at these timepoints, and relapse
    rate in the last 2 years before enrolment.
    6. The predictive role of CSF levels of endothelial biomarkers measured at Baseline on the
    clinical efficacy of Tecfidera at Months 12 and 24: fatigue, function, relapse rate, and
    cognition.
    8. Correlation between the magnitude of change in endothelial biomarker levels in sera from
    baseline to Months 12 and 24, and changes in clinical outcomes from baseline to Months 12
    and 24: fatigue, function, relapse rate, cognition.
    9. Correlation between the magnitude of change in endothelial biomarker levels in the CSF
    from baseline to Months 12, and changes in clinical outcomes from baseline to Months 12
    and 24: fatigue, function, relapse rate, cognition.
    2.2.1. Primary Endpoint
    The primary endpoint of this study is change from Baseline in the levels of biomarkers reflecting
    endothelial dysfunction in the serum at Month 24 in subjects with RRMS receiving DMF.
    2.2.2. Secondary Objectives
    The secondary objectives of this study are as follows:
    1. Change from Baseline in the levels of biomarkers reflecting endothelial dysfunction in the
    serum at Month 12 in subjects with RRMS receiving DMF.
    3
    2. Change from Baseline in the levels of biomarkers reflecting endothelial dysfunction in the
    CSF at 12 months in subjects with RRMS receiving DMF.
    3. Correlation between serum levels of endothelial biomarkers at Baseline and clinical
    measures of Tecfidera at Months 12 and 24: fatigue, cognition, and function at these
    timepoints, and relapse rate in the last 2 years before enrolment.
    4. The predictive role of serum levels of endothelial biomarkers measured at Baseline on the
    clinical efficacy of Tecfidera at Months 12 and 24: fatigue, function, relapse rate, and
    cognition.
    5. Correlation between CSF levels of endothelial biomarkers at Baseline and clinical measures
    of Tecfidera at Months 12: fatigue, cognition, and function at these timepoints, and relapse
    rate in the last 2 years before enrolment.
    6. The predictive role of CSF levels of endothelial biomarkers measured at Baseline on the
    clinical efficacy of Tecfidera at Months 12 and 24: fatigue, function, relapse rate, and
    cognition.
    8. Correlation between the magnitude of change in endothelial biomarker levels in sera from
    baseline to Months 12 and 24, and changes in clinical outcomes from baseline to Months 12
    and 24: fatigue, function, relapse rate, cognition.
    9. Correlation between the magnitude of change in endothelial biomarker levels in the CSF
    from baseline to Months 12, and changes in clinical outcomes from baseline to Months 12
    and 24: fatigue, function, relapse rate, cognition.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This single center study will evaluate endothelial biomarkers in the sera and CSF in 50 subjects
    with RRMS, treatment-naïve or changing from DMTs. Subject eligibility will be determined during
    a Screening Visit. No washout period will be required.
    Subjects will have 6 scheduled clinic visits over a 24-month period: a Screening Visit, a Baseline
    Visit, and 5 additional clinic visits at Months 1, 3, 6, 12 and 24. A Safety Follow-Up Telephone
    Interview will be conducted at 2 weeks (±5 days) after the final clinic visit.
    For biomarker investigations, peripheral blood will be taken from all 50 patients at baseline, Month
    6, Month 12 and Month 24; CSF will be taken from 30 out of 50 patients at baseline and at 12
    Month.
    This single center study will evaluate endothelial biomarkers in the sera and CSF in 50 subjects
    with RRMS, treatment-naïve or changing from DMTs. Subject eligibility will be determined during
    a Screening Visit. No washout period will be required.
    Subjects will have 6 scheduled clinic visits over a 24-month period: a Screening Visit, a Baseline
    Visit, and 5 additional clinic visits at Months 1, 3, 6, 12 and 24. A Safety Follow-Up Telephone
    Interview will be conducted at 2 weeks (±5 days) after the final clinic visit.
    For biomarker investigations, peripheral blood will be taken from all 50 patients at baseline, Month
    6, Month 12 and Month 24; CSF will be taken from 30 out of 50 patients at baseline and at 12
    Month.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    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 No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    2018, august
    2018, august
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    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)
    They will continue monitoring following international guidelines after trial has ended
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
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