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    Summary
    EudraCT Number:2010-020992-21
    Sponsor's Protocol Code Number:AB06012
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-07-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-020992-21
    A.3Full title of the trial
    A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    AB1010 in treatement of patients with active rheumatoide arthritis.
    A.4.1Sponsor's protocol code numberAB06012
    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 SponsorAB Science
    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 supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointIva Nesic
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033147200582
    B.5.5Fax number0033147202411
    B.5.6E-mailiva.nesic@ab-science.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 nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Methotrexate
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMethotrexate
    D.3.2Product code not applicable
    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 INNMETHOTREXATE
    D.3.9.1CAS number 59-05-2
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5 mg
    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.IMP: 3
    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 nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cumulative response on ACR50 (ie. response from week 8 to week 24)
    E.2.2Secondary objectives of the trial
    • Response assessment:
    - Cumulative response on ACR20 (ie. response from W8 to W24),
    - Cumulative response on ACR70 (ie. response from W8 to W24),
    - Cumulative response on ACR90 (ie. response from W8 to W24)
    - ACRn from W8 to W24
    - Time to first response according to ACR20 and ACR50
    - DAS28 from week 8 to week 24:
    • DAS28 (disease activity score)
    • DAS28 < 2.6 (complete remission),
    • DAS28 ≤ 3.2 (low disease activity),
    - CRP and ESR level from week 8 to week 24
    • CRP and ESR values
    • Percentage of patients with an improvement of CRP and ESR >50%,
    between 25 and 50%, between 0 and 25% or no improvement
    • Quality of life assessment:
    - Visual assessment scale from week 8 to week 24: pain, asthenia,
    general health
    - Quality of life assessed of SF36 from W8 to W24
    - Health assessment questionnaire (HAQ) score and from W8 to W24
    - Hamilton score from W8 to W24
    - Fatigue Impact scale from W8 to W24
    • Safety assessments: Adverse events, vital signs, laboratory data.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with rheumatoid arthritis diagnosed according to ACR criteria
    for at least 6 months.
    2. Patient with ACR functional class I-III
    3. Patient who have active RA consisting of
    - ≥ 6 swollen joints (over 66 swollen joints);- ≥ 6 tender joints (over 68
    tender joints);- and at least 2 out of 3 of the following:ESR/first hour ≥
    20 mm; CRP ≥ 10 mg/L;morning stiffness ≥ 45 minutes at both
    screening and baseline.
    4. Patient who failed (defined as active RA with stable dose during 3
    months) methotrexate at a dose ≥ 15 mg/week or any DMARD including
    biologics drugs if patients previously failed methotrexate at a dose ≥ 15
    mg/week or methotrexate at a dose ≥ 15 mg/week in combination with
    any DMARD including biologics drugs (Biologic drugs being defined as
    any of the following therapies: anti-TNFα,Anti-CD20,Anti-IL1,Anti-
    IL6,CTLA4)
    5. Patient with a disease onset at > 16 years of age
    6. Patient with an adequate organ function:ACN ≥ 2 x 109/L;White blood
    cells count ≥ 4 x 109/L;Haemoglobin ≥ 10 g/dL;PLT ≥ 100 x
    109/L;AST/ALT ≤ 3 x ULN;Bilirubin ≤ 1.5 x ULN;Creatinine clearance
    >60 mL/min;Albuminemia > 1 x LLN;Proteinuria < 30 mg/dL (1+) on
    the dipstick; in case of proteinuria ≥ 1+ on the dipstick, 24 hours
    proteinuria < 1.5g/24 hours
    7. Male or female patient aged 18 to 75 years,weight>50 kg,BMI
    between 18 and 35 kg/m²
    8. No active infection (tuberculosis,HIV,hepatitis, ...)
    9. Female patient of childbearing potential (entering the study after a
    menstrual period and who have a negative pregnancy test),who agrees
    to use two highly effective methods (one for the patient and one for the
    partner) of medically acceptable forms of contraception during the study
    and for 3 months after the last treatment intake.Acceptable forms of
    contraception include:A documented placement of an intrauterine device
    (IUD) or intrauterine system (IUS) and the use of a barrier method
    (condom or occlusive cap [diaphragm or cervical/vault caps] used with
    spermicidal foam/gel/film/cream/suppository);Documented tubal
    ligation (female sterilization). In addition, a barrier method (condom or
    occlusive cap [diaphragm or cervical/vault caps] used with spermicidal
    foam/gel/film/cream/suppository) should also be used;Double barrier
    method:Condom and occlusive cap (diaphragm or cervical/vault caps)
    with spermicidal foam/gel/film/cream/suppository;Any other
    contraceptive method with a documented failure rate of <1% per
    year;Abstinence
    10. Male patients must use medically acceptable methods of
    contraception if your female partner is pregnant from the time of the
    first administration of the study drug until three months following
    administration of the last dose of study drug.Acceptable methods
    include:Condom;If you have undergone surgical sterilization (vasectomy
    with documentation of azoospermia) a condom should also be used. Male
    patients must use two highly effective methods (one for the patient and
    one for the partner) of medically acceptable forms of contraception
    during the study and for 3 months after the last treatment intake. The
    acceptable methods of contraception are as follows: Condom and
    occlusive cap (diaphragm or cervical/vault caps) with spermicidal
    foam/gel/film/cream/suppository; Surgical sterilization (vasectomy
    with documentation of azoospermia) and a barrier method (condom or
    occlusive cap [diaphragm or cervical/vault caps] used with spermicidal
    foam/gel/film/cream/suppository);Your female partner uses oral
    contraceptives (combination oestrogen/progesterone pills), injectable
    progesterone or subdermal implants and a barrier method (condom or
    occlusive cap [diaphragm or cervical/vault caps] used with spermicidal;
    foam/gel/film/cream/suppository);Medically prescribed topicallyapplied
    transdermal contraceptive patch and a barrier method (condom
    or occlusive cap [diaphragm or cervical/vault caps] used with
    spermicidal foam/gel/film/cream/suppository);Your female partner has undergone documented tubal ligation (female sterilization). In addition,
    a barrier method (condom or occlusive cap [diaphragm or cervical/vault
    caps] used with spermicidal foam/gel/film/cream/suppository) should
    also be used; Your female partner has undergone documented placement
    of an intrauterine device (IUD) or intrauterine system (IUS) and the use
    of a barrier method (condom or occlusive cap [diaphragm or
    cervical/vault caps] used with spermicidal
    foam/gel/film/cream/suppository); Abstinence.
    11. Female patient of childbearing potential must have a negative
    pregnant test at screening and baseline
    12. Patient able and willing to comply with study visits and procedures
    per protocol
    13. Patient able to understand, sign, and date the written informed
    consent form at the screening visit prior to any protocol-specific
    procedures being performed.
    14. Patient able to understand the patient card and to follow the patient
    card procedures in case of signs or symptoms of severe neutropenia or
    severe cutaneous toxicity, during the first 2 months of treatment
    E.4Principal exclusion criteria
    1. Patient from whom the use of methotrexate is contraindicated as per
    its SPC (i.e. patient with severe renal or liver failure, patient with preexisting
    blood dyscrasia, patient with alcohol abuse, patient with acute
    or chronic infection, patient with methotrexate intolerance, patient being
    treated with live attenuated vaccine)
    2. Patient with documented fibromyalgia
    3. Patient who have had a major surgery within 2 weeks prior to study
    entry
    4. Patient with lactose intolerance
    5. Patient presenting with cardiac disorders defined by at least one of
    the following conditions:
    • Patient with recent cardiac history (within 6 months) of:
    - Acute coronary syndrome
    - Acute heart failure (class III or IV of the NYHA classification)
    - Significant ventricular arrhythmia (persistent ventricular tachycardia,
    ventricular fibrillation, resuscitated sudden death)
    • Patient with cardiac failure class III or IV of the NYHA classification
    • Patient with severe conduction disorders which are not prevented by
    permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    • Syncope without known aetiology within 3 months
    • Uncontrolled severe hypertension, according to judgment of the
    investigator, or symptomatic hypertension
    6. Patient with history of primary malignancy < 5 years; except treated
    basal cell skin cancer or cervical carcinoma in situ
    7. Patient with a severe and/or uncontrolled medical condition
    8. Pregnant or lactating woman
    9. Patient with history of poor compliance or history of drug/alcohol
    abuse, or excessive alcohol beverage consumption that would interfere
    with the ability to comply with the study protocol, or current or past
    psychiatric disease that might interfere with the ability to comply with
    the study protocol or give informed consent.
    10. Patient who were treated with methotrexate >20 mg cannot be
    included in the study
    Previous treatments:
    11. Administration of a DMARD (except methotrexate) within 4 weeks
    (or 5 half-lives, whichever is longer) prior to baseline except for
    leflunomide which requires a specific wash-out period of 12 weeks
    before baseline and infliximab which requires a wash-out period of 8
    weeks.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative response on ACR50 (ie. response from week 8 to week
    24)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cumulative response on ACR20 (ie. response from week 8 to week 24)
    E.5.2Secondary end point(s)
    • Response assessment:
    - Cumulative response on ACR20 (ie. response from week 8 to week 24),
    - Cumulative response on ACR70 (ie. response from week 8 to week 24),
    - Cumulative response on ACR90 (ie. response from week 8 to week 24)
    - ACRn from week 8 to week 24
    - Time to first response according to ACR20 and ACR50
    - DAS28 from week 8 to week 24:
    • DAS28 (disease activity score)
    • DAS28 < 2.6 (complete remission),
    • DAS28 ≤ 3.2 (low disease activity),
    - CRP and ESR level from week 8 to week 24
    • CRP and ESR values
    • Percentage of patients with an improvement of CRP and ESR >50%,
    between 25 and 50%, between 0 and 25% or no improvement
    • Quality of life assessment:
    - Visual assessment scale from week 8 to week 24:
    -pain
    -asthenia
    -general health
    - Quality of life assessed of SF36 from week 8 to week 24
    - Health Assessment Questionnaire (HAQ) score and from week 8 to
    week 24
    - Hamilton score from week 8 to week 24
    - Fatigue Impact scale from week 8 to week 24
    • Safety assessments: Adverse events, vital signs, laboratory data.
    E.5.2.1Timepoint(s) of evaluation of this end point
    response from week 8 to week 24
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Bosnia and Herzegovina
    Czech Republic
    Greece
    India
    Mexico
    Monaco
    Morocco
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Taiwan
    Thailand
    Tunisia
    Ukraine
    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
    At week 24, in case of clinical benefit/response, defined as ACR20
    reached and if recommended by the investigator, patients will have the
    possibility to enter an extension period
    - The maximum exposure to treatment is 2 years.
    - After 2 years patients will be able to continue treatment only if a
    documented favourable benefit/risk balance is established patient per
    patient by the investigator and a resignature of the ICF to warn the
    patient on potential long term risks.).
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 140
    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)
    NOT DIFFERENT
    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 Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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