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    Summary
    EudraCT Number:2010-020515-37
    Sponsor's Protocol Code Number:CFTY720D2399
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-27
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-020515-37
    A.3Full title of the trial
    A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.
    Jednoramenné, otevřené, multicentrické klinické hodnocení ke stanovení dlouhodobé bezpečnosti a snášenlivosti přípravku fingolimod 0,5 mg (FTY720) podávaného perorálně jednou denně nemocným s relabujícími formami roztroušené sklerózy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis
    Studie hodnotící dlouhodobou bezpečnost a snášenlivost fingolimodu v dávce 0,5 mg, podávaného jednou denně nemocným s relabujícími (opětovné objevení příznaků nemoci) formami roztroušené sklerózy.
    A.4.1Sponsor's protocol code numberCFTY720D2399
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis s.r.o.
    B.5.2Functional name of contact pointInformační služba - klin. hodnocení
    B.5.3 Address:
    B.5.3.1Street AddressNa Pankráci 1724/129
    B.5.3.2Town/ cityPraha 4
    B.5.3.3Post code140 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420225 775 207
    B.5.5Fax number+420225 775 205
    B.5.6E-maildotazy.klinickehodnoceni@novartis.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 Gilenya
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    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 nameFingolimod
    D.3.2Product code FTY720D
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNFingolimod
    D.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720D
    D.3.9.3Other descriptive nameFTY720
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Roztroušená skleróza
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    Roztroušená skleróza
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    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
    This study is designed to evaluate the long-term safety and tolerability of fingolimod 0.5 mg/day in patients with MS for the duration of the study.
    E.2.2Secondary objectives of the trial
    This study will also evaluate long-term efficacy of fingolimod 0.5 mg/day in patients with MS, as measured by disability progression, brain volume (atrophy), T1- (non-enhanced) and T2-weighted lesion volume and MS relapse occurrence in Study Part One.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this study have to fulfill all of the following criteria:
    1. Written informed consent must be obtained before any assessment is performed.
    2. Patients who have completed designated ongoing or planned Novartis global clinical trials with fingolimod and are unable to obtain fingolimod outside a clinical trial.
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
    1. Premature permanent discontinuation from any fingolimod study due to:
    a. An adverse event or serious adverse event or laboratory abnormality.
    b. Conditions leading to permanent study drug discontinuation.
    Patients who temporarily or permanently discontinued from any fingolimod study because of pregnancy can be re-enrolled.
    2. Pregnant or nursing (lactating) women where pregnancy is defined asthe state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
    Patients who temporarily or permanently discontinued from any fingolimod study because of pregnancy can be re-enrolled.
    3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using highly effective contraception during the study and for 2 months after stopping treatment. 'Highly effective contraception'defined as contraception which results in less than 1% unwanted pregnancies whenused properly according to the label.Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to baseline. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    4. Chronic disease of the immune system other than MS which may require immunosuppressive treatment.
    5. Severe active infection or active chronic infection.
    6. Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
    7. Treatment with monoclonal antibodies (including Natalizumab) in the past 3 months.
    8. Uncontrolled diabetes (HbA1c>9%).
    9. Macular edema at Baseline.
    10. Any medically unstable condition that may interfere with the patient's ability to cooperate and comply with the study procedures, as assessed by the treating physician.
    11. Any of the following cardiovascular conditions:
    a. myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease;
    b. cardiac failure at time of Screening (Class III & IV, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
    c. patients receiving current treatment with Class Ia and III antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline, procainamide);
    d. second-degree AV block Type II or third-degree AV block or corrected QTc inverval >450 msec in males or 470 msec in females;
    e. sick sinus syndrome or sino-atrial heart block;
    f. uncontrolled hypertension despite prescribed medications.
    12. Any of the following pulmonary conditions during the previous fingolimod study or observed at enrollment visit:
    a. severe respiratory disease or pulmonary fibrosis;
    b. active tuberculosis;
    c. in patients enrolling from studies with regular spirometry: reduction of FEV1, FVC and/or DLCO below 60% of core study baseline values or if FEV1, FVC and/or DLCO at extension study baseline is the second of two consecutive pulmonary function tests with values <80% of core study baseline.
    13. Severe liver impairment or chronic liver disease.
    14. Positive screening for serological markers for hepatitis A, B, C, and E indicating acute or chronic infection:
    • anti-hepatitis A virus IgM,
    • hepatitis B surface antigen and/or anti-hepatitis B core antigen IgM,
    • anti-hepatitis C virus IgG or IgM,
    • anti-hepatitis E virus IgM (if positive IgG: do hepatitis E virus-RNA polymerase chain reaction; if negative, patient can be included).
    Note: The following patients, assuming they have normal aminotransferase activities, can be included in the trial:
    • those testing positive for hepatitis B surface antibody, indicating hepatitis B immunization -OR-
    • those testing positive for anti-hepatitis B core antigen IgG, indicating acured hepatitis B -OR-
    • those testing positive for anti-hepatitis A virus IgG, indicating a cured hepatitis A.
    E.5 End points
    E.5.1Primary end point(s)
    For Part 1: Long-term safety will be assessed based on adverse events (AEs), Physical/neurological examination, laboratory evaluation, eye exam, ECG and vital signs, as well as other investigations performed when clinically indicated.
    For Part 2:
    During Study Part Two, only adverse events, first dose monitoring, vital signs, Ophthalmological exam/OCT, physical/neurological examination and relapse are collected.
    The follow-up safety data after discontinuation of the study treatment in Study Part One or Study Part Two will also be summarized where appropriate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For Part 1: Visits every 3 months through Month 12 (v5); Visits every 6 months beginning after Month 12 at Month 18 (v6). Biomarkers to be collected at EOS in a subset of patients meeting pre-specified criteria, eye examination yearly after the first year, urine pregnancy test at the 6 months visit

    For Part 2:
    Visits at Month 1, Month 3, Month 6*, Month 12*, and every 6 months until Study Completion.
    * No eye exam.
    E.5.2Secondary end point(s)
    MRI, MS relapse, EDSS scores, MSFC scores in Study Part One only
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits every 3 months through Month 12 (v5); Visits every 6 months beginning after Month 12 at Month 18 (v6)
    MRIs at EOS visit
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Health-related quality of life.
    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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA500
    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
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    Denmark
    Egypt
    Estonia
    Finland
    France
    Germany
    Greece
    Guatemala
    Hungary
    Ireland
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Netherlands
    Norway
    Panama
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    Jordan
    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
    Patients not eligible for reimbursed, commercial Gilenya will be offered continued study participation in Part Two until their scheduled study visit closest to 30-Jun-2018 (+/- 30 day visit window).
    For other patients do not enter in Part Two of the trial see details in the protocol 3.1 Study design
    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.1.1.1In 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.1.3Elderly (>=65 years) Yes
    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 state148
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 5000
    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)
    The investigator must provide follow-up medical care for all patients who are prematurely discontinued from the study, or must refer them back to their referring physician for appropriate care.
    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 Decision2010-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-19
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