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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-003778-27
    Sponsor's Protocol Code Number:0881A8-205
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-01
    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 number2004-003778-27
    A.3Full title of the trial
    A Randomized Double-Blind Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25 mg Twice Weekly in Subjects with Moderate to Severe Persistent Asthma
    A.4.1Sponsor's protocol code number0881A8-205
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Enbrel (etanercept)
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd.
    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.3.1Product nameEnbrel (etanercept)
    D.3.2Product code 0881
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor code0881
    D.3.9.3Other descriptive nameTNR-001; TNFR:Fc
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typeHuman tumour necrosis factor receptor p75 fusion protein produced by recombinant DNA technology.
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe asthmatics
    MedDRA Classification
    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 efficacy and safety of etanercept 25 mg twice weekly in subjects with moderate to severe persistent asthma
    E.2.2Secondary objectives of the trial
    To assess patient reported outcomes and pharmacodynamics.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. 18 to 70 years of age.
    2. Asthma diagnosed at least 1 year prior to randomization.
    3. Moderate to severe persistent asthma as defined by National Heart, Lung and Blood Institute (NHLBI) expert panel report.
    4. Demonstrated reversibility of at least 9% (actual) with inhaled salbutamol/albuterol during the screening period.
    5. Forced expiratory volume in 1 second (FEV1) 50 – 80% predicted demonstrable at least 6 hrs after short-acting ß2 agonist or 12 hrs after long-acting ß2 agonist at screening or baseline. Pulmonary function tests performed at both screening and baseline visits.
    6. Minimum total average per item score >= 2 based on the asthma control questionnaire during the screening period.
    7. Subjects must be on a high-dose inhaled corticosteroid (ICS) (at least 1000 micro g/day of beclomethasone CFC, 500 micro g/day baclomethasone HFA, 500 micro g/day fluticasone, 1000 micro g/day budesonide, or equivalent).
    8. Subjects must be on stable doses of their current medications for asthma for at least 4 weeks before randomization. Subjects must not be on methotrexate or azathioprine within 6 weeks of baseline and cyclophosphamide within 6 months of baseline.
    9. Sexually active women of childbearing potential and sexually active men participating in the study must use a medically acceptable form of contraception. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
    10. Negative result of serum ß-human chorionic gonadotropin (ß –HCG) pregnancy test taken at screening for all women except those surgically sterile or at least 1 year postmenopausal.
    11. Subject or designee must have the ability to inject test article subcutaneously.
    12. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
    13. Ability to store injectable test article at 2°C to 8°C
    E.4Principal exclusion criteria
    1. Previous treatment with etanercept, antibody to TNFa, or other TNFa inhibitors.
    2. Received any investigational agents or other biologic agents within 3 months of randomization.
    3. Received any live (attenuated) vaccine within 4 weeks prior to randomization
    4. Current use of cigarettes or cigars, or smoking history of > 10 pack years.
    5. Abnormality in blood chemistry or hematology profiles: hemoglobin <= 85 g/L; hematocrit <= 27%; platelet count <= 125 x 10 to the power 9/L; white blood cell count <= 3.5 x 10 to the power 9/L; serum creatinine >= 175 micro mol/L; aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) >= 2 times the laboratory’s upper limit of normal; or other clinically important laboratory abnormalities.
    6. Respiratory tract infection within 4 weeks of baseline.
    7. Significant concurrent medical conditions at the time of screening, including: Concurrent chronic obstructive pulmonary disease (COPD), or any significant respiratory diseases. Presence of active infection or any underlying diseases that could predispose subjects to infections. Tuberculosis (follow your country's guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF treatment). Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 180 mm Hg or screening diastolic blood pressure of greater than 110 mm Hg). Myocardial infarction within 12 months of the screening visit. Unstable angina pectoris. Class III or IV congestive heart failure as defined by the NYHA. Uncompensated congestive heart failure. Diagnosis of multiple sclerosis or other central demyelinating diseases. Presence or history of confirmed blood dyscrasias. Uncontrolled insulin-dependent diabetes mellitus. Any rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or associated syndromes. Open cutaneous ulcers. Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma). Known human immunodeficiency virus (HIV) infection. Presence of hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening. Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
    7.Pregnant or breast-feeding women.
    8. History of poor compliance.
    9. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
    10. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
    11. Employment by the investigator or reporting directly or indirectly to the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Change in FEV 1 % predicted from baseline to week 12 (before bronchodilator administration).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    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.8.3 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.8.6 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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Final visit will be the follow-up visit scheduled to occur approximately 2 weeks after the last on-therapy visit (week 12).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 2005-03-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 120
    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 Decision2005-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-07-10
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