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    Summary
    EudraCT Number:2017-002264-41
    Sponsor's Protocol Code Number:P160932J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2017-07-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002264-41
    A.3Full title of the trial
    Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet
    " Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease"
    Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet
    " Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    ITAC
    A.4.1Sponsor's protocol code numberP160932J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailhouria.mebarek@aphp.fr
    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 Remicade 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen biologics B.V
    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 name Remicade 100 mg
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinfliximab
    D.3.9.3Other descriptive nameinfliximab
    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.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 Yes
    D.2.1.1.1Trade name cyclophosphamide
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SAS
    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 namecyclophosphamide
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcyclophosphamide
    D.3.9.3Other descriptive namecyclophosphamide
    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
    Induction Therapy with Anti-TNF vs Cyclophosphamide in severe Behçet disease
    Induction Therapy with Anti-TNF vs Cyclophosphamide in severe Behçet disease
    E.1.1.1Medical condition in easily understood language
    Behcet disease
    maladie de Behcet
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004212
    E.1.2Term Behcet's disease
    E.1.2System Organ Class 100000017240
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the benefit of infliximab comparatively to that of cyclophosphamide in severe life-threatening Behçet's disease
    To assess the benefit of infliximab comparatively to that of cyclophosphamide in severe life-threatening Behçet's disease
    E.2.2Secondary objectives of the trial
    To estimate and compare the rate and time to occurrence of relapses or worsening
    To estimate and compare the cumulative dose of steroids
    To estimate and compare the adverse events
    To estimate and compare the mean change in SF-36 quality-of-life
    To estimate and compare the rate of remission according to organs involved
    To compare the changes in acute-phase reactants,
    To estimate and compare the changes in CNS involvement
    To estimate and compare the changes in Cardio-vascular involvement
    Survival and event free survival
    To estimate and compare the changes in other BD manifestations
    To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
    To assess serum concentration measurement of TNFa inhibitor
    To assess fertility in women with reproductive potential
    To estimate and compare the rate and time to occurrence of relapses or worsening
    To estimate and compare the cumulative dose of steroids
    To estimate and compare the adverse events
    To estimate and compare the mean change in SF-36 quality-of-life
    To estimate and compare the rate of remission according to organs involved
    To compare the changes in acute-phase reactants,
    To estimate and compare the changes in CNS involvement
    To estimate and compare the changes in Cardio-vascular involvement
    Survival and event free survival
    To estimate and compare the changes in other BD manifestations
    To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
    To assess serum concentration measurement of TNFa inhibitor
    To assess fertility in women with reproductive potential
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age superior or equal 12 years old
    2. Written inform consent (Informed Consent should be obtained from the legal guardian in accordance with regional laws or regulations for patients 12 to 17 years of age)
    3. Diagnosis of BD according to international criteria for BD (ICBD) (see Appendix 1).
    4. Life threatening active BD defined as 1 of the
    following disease categories and according to the validated international definition:
    - Major vessel disease: arterial aneurysms or arterial stenosis, myocarditis and/or major deep vein thrombosis (i.e. inferior vena cava, superior vena cava, cardiac cavity thrombosis, pulmonary embolism, supra-hepatic vessels, renal and mesenteric vessels). Diagnosis of major vessel involvement will be done using vascular doppler sonography, echocardiography, angio-CT scan and/or cardiac magnetic resonance imaging (MRI).
    - Central nervous system involvement: encephalitis or meningoencephalitis or myelitis. The diagnosis of neuro-Behçet's (CNS involvement) will be based on objective neurological symptoms that were associated with neuroimaging (CNS and/or medullar MRI) findings suggestive of BD-related CNS involvement. Cerebrospinal fluid (CSF) findings showing aseptic inflammation may be associated.
    6. Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
    7. For female subjects of child-bearing age, a negative pregnancy test
    8. For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 6 months after stopping therapy. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Inclusion (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, or condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
    9. A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) or a positive tuberculin skin test (?6 months) is eligible if her/his chest X-ray does not show evidence suggestive of active TB disease and there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary TB disease. These subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course.
    10. HIV negative serology and negative HBs Ag test (?1 month)
    1. Age superior or equal 12 years old
    2. Written inform consent (Informed Consent should be obtained from the legal guardian in accordance with regional laws or regulations for patients 12 to 17 years of age)
    3. Diagnosis of BD according to international criteria for BD (ICBD) (see Appendix 1).
    4. Life threatening active BD defined as 1 of the
    following disease categories and according to the validated international definition:
    - Major vessel disease: arterial aneurysms or arterial stenosis, myocarditis and/or major deep vein thrombosis (i.e. inferior vena cava, superior vena cava, cardiac cavity thrombosis, pulmonary embolism, supra-hepatic vessels, renal and mesenteric vessels). Diagnosis of major vessel involvement will be done using vascular doppler sonography, echocardiography, angio-CT scan and/or cardiac magnetic resonance imaging (MRI).
    - Central nervous system involvement: encephalitis or meningoencephalitis or myelitis. The diagnosis of neuro-Behçet's (CNS involvement) will be based on objective neurological symptoms that were associated with neuroimaging (CNS and/or medullar MRI) findings suggestive of BD-related CNS involvement. Cerebrospinal fluid (CSF) findings showing aseptic inflammation may be associated.
    6. Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
    7. For female subjects of child-bearing age, a negative pregnancy test
    8. For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 6 months after stopping therapy. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Inclusion (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, or condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
    9. A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) or a positive tuberculin skin test (?6 months) is eligible if her/his chest X-ray does not show evidence suggestive of active TB disease and there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary TB disease. These subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course.
    10. HIV negative serology and negative HBs Ag test (?1 month)
    E.4Principal exclusion criteria
    1. Evidence of active Tuberculosis
    2. HIV or active HBV infection (HBs Ag+).
    3. Pregnancy or lactation
    4. Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent
    for more than 6 weeks continuously prior to the inclusion visit or taking more than 3000 mg methylprednisolone 4 weeks prior to the inclusion visit
    5. Alcohol or drug dependance
    6. Severe renal (creatinine clairance <30ml/min/1,73m2) or liver insufficiency
    7. Heart failure ? stage III / IV NYHA,
    8. History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix or excised basal cell or squamous cell carcinoma of the skin.
    10. History of multiple sclerosis and/or demyelinating disorder
    11. History of severe allergic or anaphylactic reactions to cyclophosphamide or infliximab
    12. Infectious disease:
    - Infection requiring treatment with antibiotics within 2 weeks prior to Inclusion
    - History of recurrent infection
    14. Laboratory values assessed during Inclusion:
    - Hemoglobin < 8 g/dL
    - WBC < 2.0 x 103/mm3
    - Platelet count < 70 x 103/mm3
    15. Use of the following systemic treatments during the specified periods:
    - Treatment with systemic biologic therapy or with cyclophosphamide within 3 months prior to Inclusion
    - if on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion, these drugs must be withdrawn prior to receiving the cyclophosphamide or infliximab dose on Day 1
    16. Any live (attenuated) vaccine within 4 weeks prior inclusion; recombinant or killed virus vaccines are permitted.
    17. Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
    1. Evidence of active Tuberculosis
    2. HIV or active HBV infection (HBs Ag+).
    3. Pregnancy or lactation
    4. Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent
    for more than 6 weeks continuously prior to the inclusion visit or taking more than 3000 mg methylprednisolone 4 weeks prior to the inclusion visit
    5. Alcohol or drug dependance
    6. Severe renal (creatinine clairance <30ml/min/1,73m2) or liver insufficiency
    7. Heart failure ? stage III / IV NYHA,
    8. History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix or excised basal cell or squamous cell carcinoma of the skin.
    10. History of multiple sclerosis and/or demyelinating disorder
    11. History of severe allergic or anaphylactic reactions to cyclophosphamide or infliximab
    12. Infectious disease:
    - Infection requiring treatment with antibiotics within 2 weeks prior to Inclusion
    - History of recurrent infection
    14. Laboratory values assessed during Inclusion:
    - Hemoglobin < 8 g/dL
    - WBC < 2.0 x 103/mm3
    - Platelet count < 70 x 103/mm3
    15. Use of the following systemic treatments during the specified periods:
    - Treatment with systemic biologic therapy or with cyclophosphamide within 3 months prior to Inclusion
    - if on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion, these drugs must be withdrawn prior to receiving the cyclophosphamide or infliximab dose on Day 1
    16. Any live (attenuated) vaccine within 4 weeks prior inclusion; recombinant or killed virus vaccines are permitted.
    17. Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
    E.5 End points
    E.5.1Primary end point(s)
    Primary assessment criterion will be the complete clinical response at week 22 after randomization
    secondary criteria:
    To estimate and compare the rate and time to occurrence of relapses or worsening
    To estimate and compare the cumulative dose of steroids
    To estimate and compare the adverse events
    To estimate and compare the mean change in SF-36 quality-of-life (see Appendix 3)
    To estimate and compare the rate of remission according to organs involved
    To compare the changes in acute-phase reactants,
    To estimate and compare the changes in CNS involvement
    To estimate and compare the changes in Cardio-vascular involvement
    Survival and event free survival
    To estimate and compare the changes in other BD manifestations
    To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
    To assess serum concentration measurement of TNFa inhibitor
    Primary assessment criterion will be the complete clinical response at week 22 after randomization
    secondary criteria:
    To estimate and compare the rate and time to occurrence of relapses or worsening
    To estimate and compare the cumulative dose of steroids
    To estimate and compare the adverse events
    To estimate and compare the mean change in SF-36 quality-of-life (see Appendix 3)
    To estimate and compare the rate of remission according to organs involved
    To compare the changes in acute-phase reactants,
    To estimate and compare the changes in CNS involvement
    To estimate and compare the changes in Cardio-vascular involvement
    Survival and event free survival
    To estimate and compare the changes in other BD manifestations
    To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
    To assess serum concentration measurement of TNFa inhibitor
    E.5.1.1Timepoint(s) of evaluation of this end point
    LSLV
    E.5.2Secondary end point(s)
    Primary assessment criterion will be the complete clinical response at week 22 after randomization
    secondary criteria:
    To estimate and compare the rate and time to occurrence of relapses or worsening
    To estimate and compare the cumulative dose of steroids
    To estimate and compare the adverse events
    To estimate and compare the mean change in SF-36 quality-of-life (see Appendix 3)
    To estimate and compare the rate of remission according to organs involved
    To compare the changes in acute-phase reactants,
    To estimate and compare the changes in CNS involvement
    To estimate and compare the changes in Cardio-vascular involvement
    Survival and event free survival
    To estimate and compare the changes in other BD manifestations
    To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
    To assess serum concentration measurement of TNFa inhibitor
    Primary assessment criterion will be the complete clinical response at week 22 after randomization
    secondary criteria:
    To estimate and compare the rate and time to occurrence of relapses or worsening
    To estimate and compare the cumulative dose of steroids
    To estimate and compare the adverse events
    To estimate and compare the mean change in SF-36 quality-of-life (see Appendix 3)
    To estimate and compare the rate of remission according to organs involved
    To compare the changes in acute-phase reactants,
    To estimate and compare the changes in CNS involvement
    To estimate and compare the changes in Cardio-vascular involvement
    Survival and event free survival
    To estimate and compare the changes in other BD manifestations
    To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
    To assess serum concentration measurement of TNFa inhibitor
    E.5.2.1Timepoint(s) of evaluation of this end point
    LSLV
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 concerned28
    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 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 years3
    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 Yes
    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) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-07-19. Yes
    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 state52
    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 Decision2017-09-20
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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