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    Summary
    EudraCT Number:2011-005260-20
    Sponsor's Protocol Code Number:ML28096
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-005260-20
    A.3Full title of the trial
    Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.
    A.3.2Name or abbreviated title of the trial where available
    ACT-TAPER
    A.4.1Sponsor's protocol code numberML28096
    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 SponsorRoche Products Limited
    B.1.3.4CountryUnited Kingdom
    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 supportRoche Products Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche Products Limited
    B.5.2Functional name of contact pointClinical Projects Group
    B.5.3 Address:
    B.5.3.1Street Address6 Falcon Way, Shire Park
    B.5.3.2Town/ cityWelwyn Garden City
    B.5.3.3Post codeAL7 1TW
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailwelwyn.cpg_general@roche.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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.4Pharmaceutical form Concentrate 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 INNtocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeRO4877533
    D.3.9.3Other descriptive nameIL-6 receptor inhibitor, recombinant humanized monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanized anti-human monoclonal antibody directed against the IL-6R
    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 Methotrexate 'Lederle' 2.5mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Pharma / Pfizer GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 Disodium
    D.3.9.1CAS number 7413345
    D.3.9.3Other descriptive nameMethotrexate as methotrexate disodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Yes
    D.2.1.1.1Trade name Methotrexate 'Lederle' 2.5mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Pharma / Pfizer GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 Disodium
    D.3.9.1CAS number 7413345
    D.3.9.3Other descriptive nameMethotrexate as methotrexate disodium
    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: 4
    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 Methotrexate 2.5mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form 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 INNMethotrexate Disodium
    D.3.9.1CAS number 7413345
    D.3.9.3Other descriptive nameMethotrexate as methotrexate disodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult Rheumatoid Arthritis (RA)
    E.1.1.1Medical condition in easily understood language
    Joint inflammation
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To compare the proportion of patients who maintain good/ moderate European League Against Rheumatism (EULAR) response between weeks 24 and week 56: in patients receiving RoActemra in combination with a tapering dose of MTX versus patients receiving RoActemra in combination with a stable dose of MTX.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of RoActemra with tapering MTX dosage versus RoActemra in combination with stable MTX dosage using EULAR and patient reported health assessments.

    To compare the incidence of anaemia in patients receiving RoActemra with tapering MTX dosage versus RoActemra in combination with stable MTX dosage.

    To compare change in work/productivity, as assessed by quality of life changes in patients receiving RoActemra with tapering MTX dosage versus RoActemra in combination with stable MTX dosage.

    To compare the safety of RoActemra with tapering MTX dosage versus RoActemra in combination with stable MTX dosage, with regards to adverse events and laboratory assessments.

    To assess the proportion of patients able to discontinue MTX.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or non-pregnant, non-nursing female.
    2.≥ 18 years of age.
    3.Patients currently experiencing active severe RA (DAS28 >5.1) according to the EULAR/ACR criteria for the diagnosis of RA at start of treatment (week 0).
    4.Patients should have inadequately responded to a trial of 2 DMARDs, including MTX (as defined by NICE) and have not been previously treated with a biologic agent, such as a TNF inhibitor. NICE define a trial of DMARDs (including MTX) as being normally of 6 months, with 2 months at standard dose.
    5.Patients with a history of parenteral (subcutaneous or intramuscular) MTX prior to start of treatment (week 0) are eligible. However, prior to treatment (day 1) these patients must have been on a stable dose of oral MTX of at least 10 mg/week.
    6.If patients are receiving an oral corticosteroid, the dose must have been ≤ 10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to start of treatment (day 1).
    7.Patients receiving treatment on an outpatient basis.
    8.Patients able and willing to give written informed consent and comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    Disease
    1.Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomisation
    2.Rheumatic autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and Sjögren’s Syndrome with RA are permitted.
    3.Functional class IV as defined by ACR Classification of Functional Status in RA
    4.Prior history of/current inflammatory joint disease other than RA
    Drug-specific
    5.Treatment with leflunomide, or cholestyramine washout within 3 months prior to enrolment.
    6.Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
    7.Previous treatment with RoActemra
    8.Previous treatment with any biologic drug that is used in the treatment of RA
    9.Any previous treatment with alkylating agents eg as cyclophosphamide or chlorambucil, or with total lymphoid irradiation
    10.Treatment with IV gamma globulin, plasmapheresis or Prosorba column within 6 months before enrolment
    11.Intra-articular/parenteral corticosteroids within 6 weeks prior to enrolment
    12.Immunisation with a live/attenuated vaccine within 4 weeks prior to enrolment
    Laboratory analyses (at screening)
    13.Serum creatinine > 142 μmol/L (1.6 mg/dL) in female patients and > 168 μmol/L (1.9 mg/dL) in male patients
    14.ALT (SGPT) or AST (SGOT)> 2 x ULN
    15.Platelets< 100 x 109/L (100,000/mm3)
    16. Haemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
    17.White blood cells< 1.0 x 109/L (1000/mm3), ANC< 1.0 x 109/L (1000/mm3)
    18. Absolute lymphocyte count< 0.5 x 109/L (500/mm3)
    19.Positive hepatitis B virus surface antibody (HBsAg) or Hepatitis C virus (HCV) antibody
    20.Total bilirubin> ULN
    21.Triglycerides> 10 mmol/L (>900 mg/dL) at screening (non-fasting or fasting)
    General medical
    22.Pregnant women or breastfeeding mothers
    23.Females of child-bearing potential not using reliable means of contraception
    24.History of severe allergic/anaphylactic reactions to human, humanised, or murine monoclonal antibodies
    25.Chest X-Ray (CXR) evidence of any clinically significant abnormality
    26.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (incl obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease
    27.In patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment, the treating physician needs to consider the benefit-risk ratio
    28. History of chronic ulcerative lower GI disease such as Crohn’s disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforations
    29.Uncontrolled disease states, eg asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral/parenteral corticosteroids
    30.Current liver disease as determined by investigator. Patients with prior history of ALT (SGPT) elevation are not excluded
    31.Known active current/history of recurrent bacterial, viral, fungal mycobacterial, or other infections (including but not limited to tuberculosis (TB) and atypical mycobacterial disease, clinically significant abnormalities on CXR as determined by the investigator, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening (does not apply to the treatment of latent TB)
    32.History of, or currently active, primary or secondary immunodeficiency
    33.Evidence of active malignant disease, malignancies active or diagnosed within the previous 5 years (including haematological malignancies and solid tumours, except non-melanoma skin cancer that has been cured and treated cervical carcinoma in situ)
    34.Active TB requiring treatment within the previous 3 years. Patients treated for TB with no recurrence in 3 years are permitted
    35. Latent TB: Patients with latent TB are not eligible, unless having started treatment with standard anti-mycobacterial therapy before initiating RoActemra and have a negative CXR for active TB at screening. Therefore, patients should be screened for latent TB, prior to biologics use, as per local guidelines or clinical practice. The assessment of the presence or absence of latent TB will take place during the screening period. However, if local practice or guidelines allow reference to test results that were obtained prior to the screening period as part of routine clinical practice, this is allowed
    36.HIV positive patient
    37.History of alcohol, drug, or chemical abuse within the 6 months prior to screening
    38.Neuropathies or other painful conditions that might interfere with pain evaluation
    39. Patients with lack of peripheral venous access.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients maintaining previous disease activity (EULAR response) from week 24 (time of randomisation) to week 56.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 56
    E.5.2Secondary end point(s)
    Change in DAS28 score from week 24 (time of randomisation) to week 56, between the 2 randomisation arms.
    Proportion of patients who achieve score of ≤1 in TJC, SJC at week 56.
    Proportion of patients who achieve a DAS28 ≤3.2 at week 56.
    Proportion of patients who achieve DAS28 remission (DAS28 < 2.6) at week 56.
    Proportion of patients who achieve cDAS ≥ 1.2 at week 56.
    Proportion of patients who achieve CDAI remission (CDAI< 2.8) at week 56.
    Proportion of patients who achieve SDAI remission (SDAI < 3.3) at week 56.
    Improvement in physical function (HAQ, FACIT, SF 12) at week 56.
    Change in work/productivity (WPAI-SHP score) at week 56.
    Safety outcome measures:
    Incidence, nature and severity of adverse events.
    Incidence of MTX related side effects prior to (week 0 to 24) and after (week 28 to 56) randomisation and between randomisation arms.
    Change in haemoglobin from week 0 to weeks 24 and 56.
    Incidence of AEs of special interest:
    1.Infections including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives
    2.Myocardial infarction/acute coronary syndrome
    3.Gastrointestinal perforations and related events
    4.Malignancies
    5.Anaphylaxis/Hypersensitivity reactions
    6.Demyelinating disorders
    7.Stroke
    8.Bleeding events
    9.Hepatic events
    Incidence of anti-TCZ antibodies (immunogenicity testing).
    Patient reported outcome measures:
    Improvement in physical function (HAQ scire, FACIT, SF-12), WPAI-SHP score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 24 and 52
    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.6.13.1Other scope of the trial description
    Quality of life, Immunogenicity testing
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned65
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 513
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 105
    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 state618
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 618
    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)
    Return to standard 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 Decision2012-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-10-21
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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