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    Summary
    EudraCT Number:2016-003622-16
    Sponsor's Protocol Code Number:T214/2016
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-27
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-003622-16
    A.3Full title of the trial
    Targeting SPMS: Effect of teriflunomide treatment on microglial activation in an MS patient cohort at risk of progression. A [11C]PK11195 Brain PET study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of teriflunomide on brain microglial cell activation in multiple sclerosis.
    A.4.1Sponsor's protocol code numberT214/2016
    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 SponsorTurku University Hospital
    B.1.3.4CountryFinland
    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 supportSanofi-aventis groupe
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTurku University Hospital
    B.5.2Functional name of contact pointTurku University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressKiinamyllynkatu 4-8
    B.5.3.2Town/ cityTurku
    B.5.3.3Post code20521
    B.5.3.4CountryFinland
    B.5.4Telephone number+358503294321
    B.5.6E-maillaura.airas@utu.fi
    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 AUBAGIO
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis groupe
    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 nameTeriflunomide
    D.3.2Product code L04AA31
    D.3.4Pharmaceutical form Film-coated 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 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.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
    E.1.1.1Medical condition in easily understood language
    MS disease
    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
    To perform brain PET imaging with the [11C]PK11195 radioligand to 20 RRMS patients (age 40-55) who are using teriflunomide treatment and to 10 RRMS patients not on therapy. Purpose is to compare the binding of the radioligand between the two different time points and compare the outcomes in the cohorts to see whether teriflunomide treatment alters microglial activation in RRMS.
    E.2.2Secondary objectives of the trial
    •To evaluate the total lesion load of the white matter MS plaques at different time points using MRI
    •To measure total brain, white matter (WM) and gray matter (GM) volumes using MRI at different time points
    •To determine MD (mean diffusity) and FA (fractional anisotropy) using DTI (diffusion tensor imaging) at different time points
    •To correlate the baseline microglial activation status to the clinical outcome parameters at the end of the study
    •To correlate the baseline microglial activation status to the MRI parameters
    •To compare microglial activation in the study group to microglial activation in a group of age-matched healthy controls
    •To compare microglial activation in the study group (in the beginning of the study) to microglial activation in an independent group of age-matched untreated MS-patients
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is a potential biomarker sub-study and therefore the biological samples are collected. The exact nature of the biomarker sub-study will depend on the outcome of the PET imaging and clinical follow-up results.
    E.3Principal inclusion criteria
    -Signing the consent form
    -Having used teriflunomide treatment for at least 6 months
    -40−55 years of age at the time of signing the research consent form
    -MS diagnosis in accordance with either the Poser or McDonald criteria
    -EDSS 2−6.5
    -Clear lesion load in brain MRI (>9 T2 lesions)
    E.4Principal exclusion criteria
    -Patients suffering from another brain disease in addition to MS
    -Significant pathology in the MRI scan other than MS-related pathology
    -Steroid treatment within 4 weeks prior to the scan
    -Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
    -Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
    -Severe hepatic impairment
    -Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l.
    E.5 End points
    E.5.1Primary end point(s)
    Change in microglia-activity in RRMS patients on teriflunomide treatment as measured by PET imaging and [11C]PK11195 radioligand.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 1 year.
    E.5.2Secondary end point(s)
    Comparison of the following MRI parameters
    -Evaluation of white matter lesion load in MRI scans (impact of treatment on disease inflammatory activity)
    -Evaluation of the total volume of the brain, the volume of white matter and of grey matter in MRI scans (impact of treatment on brain atrophy)
    -DTI (diffusion tensor imaging) will be used to measure the MD (mean diffusivity) and FA (fractional anisotropy) MRI scans (impact of treatment on brain atrophy)
    All the above mentioned MRI variables will also be correlated to microglial activation and clinical parameters.

    Clinical outcome parameters (EDSS, MSFC, MSIS29) and quality of life measurements (SF36, EQ5-D) will be measured and will be correlated with PET and MRI findings to evaluate whether high microglial activation is predictive of higher likelihood of progression and other measures of disability.

    Cognitive variables measured using the BICAMS test battery will be correlated with PET and MRI findings.
    E.5.2.1Timepoint(s) of evaluation of this end point
    MRI at baseline and yearly thereafter.
    Clinical outcome parameters and quality of life measurements: baseline and yearly thereafter.
    Cognitive variables: baseline and after 3 years.
    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 No
    E.6.5Efficacy No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Comparison to MS patients not on therapy and to historical MS patients and healthy controls
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparison to MS patients not on therapy.
    E.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    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 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: 30
    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 state30
    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)
    Patients will continue on their standard care as recommended by their treating neurologist.
    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 Decision2017-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
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