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    Summary
    EudraCT Number:2011-006018-15
    Sponsor's Protocol Code Number:015K-CL-RA21
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2011-006018-15
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate
    Randomizovaná, multicentrická, dvojitě zaslepená, placebem kontrolovaná, dávku zjišťující studie fáze IIb s paralelními skupinami hodnotící bezpečnost a účinnost hodnoceného léčiva ASP015K u pacientů se středně závažnou až závažnou formou revmatoidní artritidy, kteří dostatečně neodpovídali na léčbu metotrexátem
    A.4.1Sponsor's protocol code number015K-CL-RA21
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    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 supportAstellas Pharma Global Development, Inc. (APGD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Global Development, Inc. (APGD)
    B.5.2Functional name of contact pointKathyjo Shay
    B.5.3 Address:
    B.5.3.1Street Address1 Astellas Way
    B.5.3.2Town/ cityNorthbrook, IL
    B.5.3.3Post code60062
    B.5.3.4CountryUnited States
    B.5.4Telephone number001224205-5331
    B.5.5Fax number001224205-5311
    B.5.6E-mailkathyjo.shay@astellas.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 nameASP015K
    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.3.9.2Current sponsor codeASP015K
    D.3.9.3Other descriptive nameASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
    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 nameASP015K
    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.3.9.2Current sponsor codeASP015K
    D.3.9.3Other descriptive nameASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 nameASP015K
    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.3.9.2Current sponsor codeASP015K
    D.3.9.3Other descriptive nameASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    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
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10042952
    E.1.2Term Systemic rheumatoid arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects who are Methotrexate-Inadequate Responders (MTX-IR).
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is an optional sub study for Pharmacogenomics. There is no separate protocol, it is included in the main protocol.

    The pharmacogenomic research that will be conducted in the future with acquired blood samples is exploratory. The objective of this research is to comprehensively analyze:
    • Suspected disease-related genes;
    • Genes of relevance to clinical response, pharmacokinetics, and toxicity/safety issues, to be identified in a precautionary/retrospective setting
    By analyzing differing genetic polymorphisms, it may be possible to predict genetic influence on an individual subject’s response to ASP015K in terms of efficacy and/or toxicity.

    An optional whole blood sample will be collected during the Baseline visit after randomization but prior to the first dose of study drug and at weeks 4 and 12 for exploratory mRNA expression profiling to better understand the pathological mechanisms involved in RA and the effects of ASP015K on whole blood gene expression.

    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    1. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the Subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Male or female subject is at least 18 years of age at the time of Informed Consent.
    3. Subject has RA that was diagnosed according to the 1987 revised criteria of the American College of Rheumatology (ACR) at least 6 months prior to Screening.
    4. Subject has been treated with oral MTX:
    • for a minimum of 90 days
    • at a stable dose (single, unchanging dose) of 15 - 25 mg/week for a minimum of 28 days prior to the first dose of study drug
    NOTE: A lower dosage of MTX (but at least 7.5 mg/week) may be allowed only if there is an intolerance to doses ≥ 15 mg/week, as determined by the investigator.
    5. Subject’s other related medication taken for the treatment of RA at the time of Screening must meet the noted stability requirements as follows:
    • Non-steroidal anti-inflammatory drugs (NSAIDs), selective cyclo-oxygenase-2 (COX-2) inhibitors, and oral corticosteroids (≤ 10 mg
    of prednisone, or equivalent, daily) must be stable for at least 28 days prior to the start of study drug
    • Hydroxychloroquine (≤ 400 mg/day), chloroquine (≤ 250 mg/day) and sulfasalazine (≤ 3 g/day) must have been started at least 60 days prior to start of study drug and must be stable for at least 28 days prior to the start of study drug.
    6. Subject has active rheumatoid arthritis as evidenced by the following:
    • ≥ 6 tender/painful joints (using 68-joint assessment);
    • ≥ 6 swollen joints (using 66-joint assessment); and
    • C-Reactive Protein (CRP) of ≥ 0.8 mg/dL or Erythrocyte Sedimentation Rate (ESR) of ≥ 28 mm/hr at Screening.
    Subjects must continue to meet both joint count criteria at the Baseline visit prior to being randomized.
    7. Subject meets the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III at Screening. and Baseline.
    8. Female subject must be either:
    • Of non child bearing potential:
     post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
     documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
    • Or, of childbearing potential,
     must agree to have a negative serum pregnancy test at Screening, and/
     must use use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 60 days after the final study drug administration.
    9. Female subject must not be breastfeeding at Screening or during the study period, and for 60 days after the final study drug administration.
    10. Female subject must not donate ova starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
    11. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
    12. Male subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.
    13. Subject must be willing and able to comply with the study requirements.
    14. Subject agrees not to participate in another interventional study while on treatment.
    *Acceptable forms of birth control include:
     Established use of oral, injected or implanted hormonal methods of contraception.
     Placement of an intrauterine device (IUD) or intrauterine system (IUS).
     Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    1. Subject currently has or has a history of a positive Mycobacterium tuberculosis (TB) test and does not have documentation of completion of a recommended course of antimicrobial therapy per local guidelines.
    2. Subject has an abnormal chest x-ray within 90 days of or at Screening indicative of an acute or chronic infectious process or malignancy.
    3. Subject has received live or live attenuated virus vaccination within 30 days prior to the first dose of study drug.
    4. Subject has a known history of positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody or history of a positive test for human immunodeficiency virus (HIV) infection.
    5. Subject has a history of any other autoimmune rheumatic disease, other than Sjogren’s syndrome.
    6. Subject has a previous history of clinically significant infections or illness (requiring hospitalization or requiring parenteral therapy) within 90 days of the Baseline visit, or a history of any illness that in the investigator’s opinion would preclude participation in the study.
    7. Subject has a history of any malignancy, except for successfully treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix.
    8. Subject has taken any of the following DMARDs or biologic agents within the following period prior to the first dose of study drug:
    • Gold, azathioprine, minocycline, and penicillamine – 28 days
    • Etanercept – 28 days
    • Certolizumab, adalimumab, golimumab and infliximab – 60 days
    • Cyclophosphamide – 180 days
    • Leflunomide – 60 days; if the patient has undergone a cholestyramine washout, then the period is reduced to 30 days prior to Day 1 dosing
    9. Subject has previously used a non anti-TNF biologic DMARD (e.g., anakinra, abatacept, rituximab or any other CD20 inhibitors, tocilizumab).
    10. Subject has a previous intolerance to JAK inhibitors.
    11. Subject has received intra-articular or parenteral (intravenous [IV], subcutaneous, intramuscular) corticosteroid within 28 days prior to the first dose of study drug or is currently taking > 30 mg oral morphine (or narcotic equivalent) per day.
    12. Subject has received plasma exchange therapy within 60 days prior to the start of study drug.
    13. Subject has previously received ASP015K.
    14. Subject has received any investigational agent within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
    15. Subject has received medications that are CYP3A substrates with narrow therapeutic range within 14 days prior to first dose of study drug. These medications include but are not limited to: alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine.
    16. Subject has any of the following laboratory values at Screening:
    • Hemoglobin < 10 g/dL
    • White blood cell count < 3000/mm3
    • Absolute neutrophil count (ANC) < 2000/mm3
    • Absolute lymphoctye count (ALC) < 750/mm3
    • Platelet count < 100,000/mm3
    • ALT ≥ 2 x upper limit of normal
    • AST ≥ 2 x upper limit of normal
    • Total bilirubin ≥ 1.5 x upper limit of normal
    • Estimated GFR ≤ 40 mL/min/1.73m2, as measured by the Modification of Diet in Renal Disease (MDRD) method
    • CPK > 1.5 x upper limit of normal
    25. Subject has a history of heart failure, defined as New York Heart Association (NYHA) grade 3 or greater.
    26. Subject has a history of long QT syndrome or prolonged QT interval at Screening.
    27. Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or infectious disease, or any ongoing illness which would make the subject unsuitable for the study as determined by the investigator. This includes stomatitis, gastrointestinal ulcers, or any other condition that would preclude continued treatment with methotrexate.
    28. Any condition possibly affecting oral absorption (e.g., gastrectomy, other malabsorption syndromes or clinically significant diabetic gastroenteropathy).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint, ACR20 response rate at Week 12, will be analyzed using a logistic regression model including treatment group, center and TNF past use (yes or no) as explanatory variables. Subjects who withdraw before Week 12 will be counted as non-responders.
    The hypothesis for comparisons is given as follows:
    H0: The ACR20 response rates at end of treatment for ASP015K and placebo with concomitant methotrexate are the same
    H1: The ACR20 response rates at end of treatment for ASP015K and placebo with concomitant methotrexate are not the same
    Comparisons to placebo will be performed at each ASP015K dose level. This study will not consider adjustments for multiplicity, since it is not a pivotal study. The primary analysis will be conducted using the FAS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    For secondary efficacy endpoints, the binary variables ACR50 and ACR70 response rates at Week 12 will be analyzed with a model similar to the primary analysis, and the continuous variable Change from Baseline/Day 1 to Week 12/ET in DAS28-CRP score will be analyzed using a three-way ANOVA model with the same factors as in the primary analysis, as well as interaction terms, as appropriate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Belgium
    Bulgaria
    Colombia
    Czech Republic
    Mexico
    Poland
    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
    Last Patient Last Visit
    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 months4
    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 months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 149
    F.4.2.2In the whole clinical trial 375
    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)
    Patients will be offered the opportunity to participate in an extension study. If they do not participate in the extension then patients will revert to standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-11
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