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    Summary
    EudraCT Number:2006-001152-12
    Sponsor's Protocol Code Number:EFC6260
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-21
    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 ConcernedEstonia - SAM
    A.2EudraCT number2006-001152-12
    A.3Full title of the trial
    An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period.
    A.4.1Sponsor's protocol code numberEFC6260
    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 Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis Estonia OÜ
    B.5.2Functional name of contact pointClinical Study Unit
    B.5.3 Address:
    B.5.3.1Street AddressPärnu mnt 139E/2
    B.5.3.2Town/ cityTallinn
    B.5.3.3Post code11317
    B.5.3.4CountryEstonia
    B.5.4Telephone number+372 627 3496
    B.5.5Fax number+372 627 3491
    B.5.6E-mailclinicaltrialsinfo_ee@sanofi-aventis.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 nameTeriflunomide
    D.3.2Product code HMR1726D
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTeriflunomide
    D.3.9.1CAS number 108605-62-5
    D.3.9.2Current sponsor codeHMR1726D
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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) 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 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 nameTeriflunomide
    D.3.2Product code HMR1726D
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTeriflunomide
    D.3.9.1CAS number 108605-62-5
    D.3.9.2Current sponsor codeHMR1726D
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    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
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term 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
    To demonstrate the effect of teriflunomide (7and 14 mg/d) compared to placebo for reducing conversion of patients presenting their first clinical episode consistent with MS to clinically definite MS.
    E.2.2Secondary objectives of the trial
    To demonstrate effect of teriflunomide (7and 14 mg/d) compared to placebo for: reducing conversion to definite MS by the demonstration of dissemination of MRI lesions in time, reducing annualized relapse rate, reducing MRI variables, including burden of disease (volume of abnormal brain tissue on MRI) and numnber and volume of Gd-enhanced T1 lesion; other data can be obtained from evaluation of MRI scans from the trial for explanatory evaluation, reducing accumulation of disability for at least 12 weeks as measured by EDSS, reducing patient-reported fatigue.

    To evaluate safety and tolerability of teriflunomide.

    To evaluate the long-term safety of teriflunomide in the extension period.

    Optional pharmacogenomic testing.

    To demonstrate the effect of early teriflunomide treatment (14 mg/day and 7 mg/day) compared to late teriflunomide treatment (placebo to 14 mg/day and placebo to 7 mg/day) for reducing accumulation of disability.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The objectives of the Pharmacogenomic Teriflunomide Substudy are to :
    • test the hypothesis of an association between NAT, and hepatic safety
    • assess other associations between variations in genes and clinical outcomes.

    (Please refer to the previous protocol amendment 4, version 1 (electronic 3.0), dated 1 July 2009
    E.3Principal inclusion criteria
    1.Patients with a first acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)

    2. Onset of MS symptoms occurring within 90 days of randomization

    3. A screening MRI scan (performed at Visit 1) with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS (i.e. at least one lesion is periventricular in location or ovoid in shape)
    E.4Principal exclusion criteria
    1. Unable to obtain written informed consent for the study or consent not given for HIV testing (the informed consent process should be complete with full discussion of approved therapies available to the patient. The patient must have been offered these therapies and must choose to join the study instead of accepting therapy outside of the study.)

    2. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study

    3. Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and known unlikelihood of completing the study

    4. Age < 18 years or >55 years

    5. Contraindication for MRI, e.g., presence of pacemaker, metallic implants in high-risk areas

    6. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease or prodedure/medication making implementation of the protocol or interpretation of the study results difficult or
    that would put the patient at risk by participating in the study

    7. Patients with a congenital or acquired severe immunodeficiency, a history of cancer , lymphoproliferative disease, or any patient who has received lymphoid irradiation

    8. Known history of active tuberculosis not adequately treated

    9. Persistent significant or severe infection

    10. History of drug or alcohol abuse

    11. Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

    12. Patients must not have used Adrenocorticotrophic hormone (ACTH) or systemic
    corticosteroids for 2 weeks prior to randomization

    13. Prior use within 4 weeks before randomization cholestyramine

    14. Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate

    15. Prior or concomitant use of interferons, cytokine therapy, glatiramer acetate or intravenous immunoglobulins
    16. Prior or concomitant use of natalizumab (Tysabri®)

    17. Prior treatment with teriflunomide, and prior or concomitant use of leflunomide (ARAVA®) or hypersensitivity to any of the other ingredients or excipients of the investigational product.

    18. Prior use of any investigational drug in the preceding 6 months

    19. Pregnant or breast-feeding women

    20. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.

    21. Patients wishing to parent children during the course of the trial.

    22. Patients with significantly impaired bone marrow function or significant anemia, leukopenia,
    or thrombocytopenia
    • Hematocrit <24% and/or
    • Absolute white blood cell count <4,000 cells/ mm3 (μL) and/or
    • Platelet count <150,000 cells/ mm3 (μL) and/or
    • Absolute neutrophil ≤ 1,500 cells/ mm3 (μL)

    23. Human immunodeficiency virus (HIV) positive patient

    24. Persisting elevations (confirmed by retest) of serum amylase or lipase greater than 2-fold the upper limit of normal

    25. Known history of chronic pancreatic disease or pancreatitis

    26. Liver function impairment or persisting elevations (confirmed by retest) of serum glutamicpyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST),or direct bilirubin greater than 1.5-fold the upper limit of normal

    27. Known history of active hepatitis.

    28. Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serumalbumin <3.0 g/dL

    29. Moderate to severe impairment of renal function, as shown by serum creatinine >133 μmol/L
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is efficacy (conversion to clinically definite MS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline- W12- 24-36-48-60-72-84-96 and 108
    E.5.2Secondary end point(s)
    • Conversion to definite MS based on MRI data as defined by the demonstration of dissemination of MRI lesions in time (based on the revised McDonald criteria, Appendix A) within 2 years.
    • Annualized relapse rate, defined as number of relapses per patient-year.
    • Burden of disease (volume of abnormal brain tissue on MRI) at the last visit on treatment and other MRI variables at the last visit on treatment, including number and volume of Gd-enhanced T1 lesions, volume of T2 lesions, volume of T1 hypointense lesions and atrophy.
    • Time to disability progression (12 weeks), defined as a 1.0-point increase in EDSS score (or 0.5-point increase for baseline EDSS >5.5) confirmed after at least 12 weeks.
    • Proportion of disability-free subjects as assessed by the EDSS in the 2 years of placebo-controlled period.
    • Patient-reported fatigue during the placebo-controlled period.
    • Optional pharmacogenomic testing aims at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes.
    • Long-term evaluation of safety of teriflunomide in extension period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline- W12- 24-36-48-60-72-84-96 and 108
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belarus
    Bulgaria
    Canada
    Chile
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    Turkey
    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 years
    E.8.9.1In the Member State concerned months65
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months65
    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: 600
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 600
    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 Decision2008-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-05
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