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    Summary
    EudraCT Number:2013-003177-99
    Sponsor's Protocol Code Number:A3921133
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-05
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-003177-99
    A.3Full title of the trial
    PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.
    A.4.1Sponsor's protocol code numberA3921133
    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 SponsorPfizer Inc. 235 East 42nd Street, New York, 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street AddressEast 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    B.5.5Fax number001 303 739 1119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.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 XELJANZ
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameTofacitinib citrate (commercial image)
    D.3.2Product code CP-690,550-10
    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 INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE CP-690550
    D.3.9.4EV Substance CodeSUB33105
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 nameTofacitinib citrate (clinical trial image)
    D.3.2Product code CP-690,550-10
    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 INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE CP-690550
    D.3.9.4EV Substance CodeSUB33105
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 nameEtanercept
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    An inflammatory arthritis that affects joints
    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 19.0
    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
    The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma skin cancers during study participation.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2.Must be at least 50 years of age or older.
    3.Has moderate to severe rheumatoid arthritis inadequately controlled with methotrexate alone with a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis
    4.Has ≥6 tender/painful joints on motion and ≥6 swollen joints (28 joint count)
    5.Has a C-reactive protein measured by a high sensitivity assay (hs-CRP) ≥0.3 mg/dL in the central laboratory
    6.Meets Class I, II or III of the American College of Rheumatology (ACR) 1991 Revised Criteria for Global Functional Status in RA where usual self-care activities including dressing, feeding, bathing, grooming, and toileting; avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities are subject-desired and age and sex-specific.
    7.Has taken methotrexate continuously for at least 4 months prior to the Screening visit and has taken a stable weekly dose of methotrexate with supplemental folic or folinic acid for at least 6 weeks prior to the Baseline visit.
    •Methotrexate doses less than 15 mg/week are allowed only in the presence of documented intolerance or toxicity from higher doses
    •Doses higher than 25 mg/week are not permitted under any circumstances
    •Folic acid doses should be at least 5 mg per week; folinic acid doses should be at least 2.5 mg per week.
    8.Have at least one of the following cardiovascular risk factors at screening:
    •Current cigarette smoker
    •Diagnosis of hypertension
    •High density lipoprotein (HDL) <40 mg/dL
    •Diabetes mellitus
    •Family history of premature coronary heart disease
    •Presence of extra-articular disease associated with rheumatoid arthritis, which may include nodules, Sjögren’s syndrome, anemia of chronic disease and pulmonary manifestations
    •History of coronary artery disease including a history of revascularization procedure, coronary artery bypass grafting, myocardial infarction, cardiac arrest, unstable angina, acute coronary syndrome
    9.Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    10.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
    11.Female subjects of childbearing potential must test negative for pregnancy.
    12.Female subjects who are not of childbearing potential must meet at least one of the following criteria:
    •Have undergone a documented hysterectomy and/or bilateral oophorectomy
    •Have medically confirmed ovarian failure or
    •Achieved post menopausal status
    13.Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis infection (active or latent) as evidenced by the following:
    a.Negative QuantiFERON Gold®™ In-Tube test performed at screening
    •This is required unless the subject has been adequately treated for active or latent tuberculosis or a negative QuantiFERON Gold®™ In-Tube test was previously performed and documented within the 3 months prior to screening.
    •A negative tuberculin skin test (TST) is one that is <5 mm induration and it can be substituted for the QuantiFERON Gold®™ In-Tube test only if the central laboratory is unable to perform the test or the test is reported as indeterminate after at least 2 successive attempts.
    •It is strongly recommended that subjects with a history of Bacille Calmette Guérin (BCG) vaccination be tested with the QuantiFERON Gold®™ In-Tube test.
    b.Chest radiograph taken at screening without changes suggestive of active tuberculosis (TB) infection, unless previously performed and documented within 3 months prior to screening
    c.No history of tuberculosis infection unless one of the following is documented:
    •Subject with prior or current latent tuberculosis has no evidence of active tuberculosis and must be taking or have completed an adequate course of therapy for latent tuberculosis (9 months of isoniazid in a locale where rates of primary multi-drug resistant TB infection are <5% or an alternative regimen recognized by the World Health Organization) and a chest radiograph is negative for active disease; the chest radiograph must be obtained at screening or, if previously performed and documented, within 3 months prior to screening.
    •Subject with prior active tuberculosis has no current evidence of active disease and has completed an adequate course of therapy for active tuberculosis (a multi-drug regimen recognized by the World Health Organization) and a chest radiograph is negative for active disease; the chest radiograph must be obtained at screening or, if previously performed and documented, within 3 months prior to screening
    E.4Principal exclusion criteria
    1.Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2.Subjects who are classified Class IV of the ACR 1991 Revised Criteria for Global Functional Status in RA (ie, are limited in their ability to perform usual self-care, vocational, and avocational activities).
    3.Pregnant females; breastfeeding females; sexually active males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
    4.Subjects with infections or history of infections:
    a.Any infection requiring treatment within 2 weeks prior to the Baseline visit.
    b.Any infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the past 6 months.
    c.Infected joint prosthesis at any time with the prosthesis still in situ.
    d.Recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    e.Subjects will be screened for human immunodeficiency virus (HIV). Subjects who test positive for HIV will be excluded from the study.
    f.Subjects will be screened for hepatitis B virus infection. Subjects with hepatitis B surface antigen (HBsAg) negative testing but who test positive for hepatitis B core antibody (HBcAb) must have further testing for hepatitis B surface antibody (HBsAb). If HBsAb is negative, the subject will be excluded from the study.
    g.Subjects will be screened for hepatitis C virus antibodies (HCV Ab). Subjects with positive HCV Ab tests will be reflex tested for hepatitis C virus ribonucleic acid (HCV RNA). Only subjects with negative HCV Ab or HCV RNA will be allowed to enroll in the study.
    h.Subjects are excluded for current active tuberculosis infection or prior active or latent tuberculosis that was inadequately treated or cannot be documented (See Section 4.1 Inclusion Criteria #13).
    5.Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    6.Subjects with any uncontrolled clinically significant laboratory abnormality or any of the following laboratory abnormalities:
    a.Evidence of hematopoietic disorder or hemoglobin <9 g/dL
    b.White blood cell count <3.0 x 109/L (<3000/mm3)
    c.Absolute lymphocyte count <0.5 x 109/L (<500/mm3)
    d.Absolute neutrophil count <1.0 x 109/L (<1000/mm3)
    e.Platelet count <100 x 109/L (<100,000/mm3)
    f.Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (x ULN)
    g.Estimated glomerular filtration rate (GFR) <60 mL/min using the Cockcroft-Gault formula (Appendix 3).
    7.Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation, unless further restrictions to class of compound are specified in Section 4.2 Exclusion Criteria and Section 5.5 Concomitant Medication(s).
    8.Subjects requiring or have received any prohibited concomitant medication as outlined in Appendix 2, including:
    a.Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug or at any time during treatment or within 6 weeks following discontinuation of study drug (See Section 4.4.2).
    b.Subjects who have been previously treated with tofacitinib.
    c.Subjects who are being treated with biologic or non-biologic DMARDs other than MTX or antimalarials within their specified washout window at study entry (see Table 1).
    d.Subjects who previously experienced inadequate response, intolerance, allergy or hypersensitivity to adalimumab (US, Puerto Rico and Canada) or to etanercept (all other countries) or for whom adalimumab (US, Puerto Rico and Canada) or etanercept (all other countries) are contraindicated.
    e.Subjects who are being treated with corticosteroids, other than low dose oral corticosteroids in doses equivalent to ≤10 mg prednisone per day at study entry.
    f.Subjects who require concomitant treatment with medications that are potent inhibitors of cytochrome P450 3A4 (CYP3A4), both moderate inhibitors of CYP3A4 and potent inhibitors of CYP2C19, or potent CYP inducers.
    9.Subjects who have Class III or Class IV heart failure according to the New York Heart Association (NYHA) functional classification system.
    See protocol for Exclusion criteria 10-16
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    The safety endpoints will be collected and analyzed for all subjects in the study, through the end of the study.

    Co-Primary Safety Endpoints
    The following co-primary safety endpoints will be analyzed to provide comparative rates for tofacitinib vs. the combined TNFi:
    •Malignancies, excluding non-melanoma skin cancers (adjudicated)
    •Major adverse cardiovascular events (adjudicated) defined as cardiovascular death including deaths due to coronary, cerebrovascular, cardiac (eg, sudden cardiac death) events and non-cardiac vascular deaths (eg, pulmonary embolism), and non-fatal cardiovascular events including myocardial infarction and cerebrovascular events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 [Day 1]
    Visit 2 [Month 2]
    Visit 3 [Month 3]
    Visit 4 [Month 6]
    Visits 5, 9, 13, 17, 21 [Months 9, 21, 33,45, 57]
    Visit 6, 10, 14, 18, 22 [Months 12, 24, 36, 48, 60]
    Visits 7, 11, 15, 19 [Months 15, 27, 39, 51]
    Visits 8, 12, 16, 20 [Months 18, 30, 42, 54]
    End of Study Visit [Month 60]
    E.5.2Secondary end point(s)
    Secondary Safety Endpoints
    The secondary safety endpoints will include an evaluation of the following events:
    •Opportunistic infection events including tuberculosis (adjudicated)
    •Hepatic events (adjudicated)
    •Cardiovascular events other than MACE (adjudicated)
    •All adverse events (AEs), including serious adverse events (SAEs)
    •Clinically significant abnormal laboratory parameters
    •All cause mortality (adjudicated)
    •Reasons for permanent or temporary discontinuation of study medication
    Efficacy endpoints will include:
    • Change from baseline to each post-baseline scheduled visit in DAS28-4 (CRP).
    • Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI).
    • Rate of remission at each post-baseline scheduled visit including:
    • ACR-EULAR Boolean remission (defined as the subject satisfying all of the
    following: tender joint count ≤ 1, swollen joint count ≤1, C-reactive protein ≤1 mg/dL, patient global assessment ≤1 on a 0-10 scale)
    • SDAI ≤ 3.3
    •CDAI ≤2.8
    • Rate of low disease activity (LDA) at each post-baseline scheduled visit including:
    • SDAI ≤ 11
    • CDAI ≤10
    • DAS28-4(CRP) ≤3.2
    • ACR20, ACR50, and ACR70 response rate of at each post-baseline scheduled visit
    • Change from baseline to each post-baseline scheduled visit in the HAQ-DI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 [Day 1]
    Visit 2 [Month 2]
    Visit 3 [Month 3]
    Visit 4 [Month 6]
    Visits 5, 9, 13, 17, 21 [Months 9, 21, 33,45, 57]
    Visit 6, 10, 14, 18, 22 [Months 12, 24, 36, 48, 60]
    Visits 7, 11, 15, 19 [Months 15, 27, 39, 51]
    Visits 8, 12, 16, 20 [Months 18, 30, 42, 54]
    End of Study Visit [Month 60]
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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
    Belgium
    Brazil
    Bulgaria
    Chile
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Taiwan
    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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2500
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1231
    F.4.2.2In the whole clinical trial 4000
    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)
    No special measures; subjects may be treated as per standard local practice outside the scope of the clinical trial
    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 Decision2014-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-22
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