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    Summary
    EudraCT Number:2012-002637-11
    Sponsor's Protocol Code Number:CFTY720DDE19
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002637-11
    A.3Full title of the trial
    A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis
    A.3.2Name or abbreviated title of the trial where available
    STAY
    A.4.1Sponsor's protocol code numberCFTY720DDE19
    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 GmbH
    B.1.3.4CountryGermany
    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 GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointProject Leader
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number004991127313187
    B.5.5Fax number004991127317187
    B.5.6E-mailfrancisca.blumhagen@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.2.1.2Country 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 nameFingolimod
    D.3.2Product code FTY720
    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.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720
    D.3.9.3Other descriptive nameFingolimod Hydrochloride
    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
    Treatment statisfaction in patients with relapsing remitting 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 15.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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 evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by an adherence questionnaire (Modified Morisky Scale) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by pill-count in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    To evaluate the effect of an individualized patient support program vs. standard care on fatigue, measured by mFIS in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    To evaluate the effect of an individualized patient support program vs. standard care on depression parameters, measured by the Beck depression inventory (BDI) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
    2. Male or female subjects aged 18 – 65 years.
    3. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria.
    4. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
    5. Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1).
    E.4Principal exclusion criteria
    1. Patients, who are registered in any patient support program (e.g. Extracare)
    2. Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site.
    3. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator’s discretion
    4. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
    5. Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer.
    6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum)
    7. Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.9.5 for details).
    8. Simultaneous participation in another clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 6 month
    E.5.2Secondary end point(s)
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by an adherence questionnaire (Modified Morisky Scale) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by pill-count in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    To evaluate the effect of an individualized patient support program vs. standard care on fatigue, measured by mFIS in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    To evaluate the effect of an individualized patient support program vs. standard care on depression parameters, measured by the Beck depression inventory (BDI) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 6 month
    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 Yes
    E.6.13.1Other scope of the trial description
    Treatment satisfaction
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    individualized patient support programm
    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 concerned9
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 300
    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 state300
    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 decides about further treament after the end of the study in the best interest of the patient. Gilenya is commercially available.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-25
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