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    Summary
    EudraCT Number:2005-005936-29
    Sponsor's Protocol Code Number:0881A6-318-EU
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-005936-29
    A.3Full title of the trial
    A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis
    A.4.1Sponsor's protocol code number0881A6-318-EU
    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 research 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
    B.Sponsor: 2
    B.1.1Name of SponsorWyeth Pharmaceuticals France, Wyeth Research Division
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsor
    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
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameetanercept
    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 number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 plaque psoriasis
    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 50 mg administered once weekly in subjects with psoriasis over 12 weeks.
    E.2.2Secondary objectives of the trial
    to evaluate the quality of life, pharmacokinetics as well as the open-label safety and efficacy of etanercept administered once weekly for up to 24 weeks.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Adults ≥ 18 years of age with clinically stable plaque psoriasis involving ≥ 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening.
    2. Failure to respond to, or have a contraindication to, or intolerance to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: · Methotrexate (MTX) · Acitretin· Cyclosporine
    · Ultraviolet A (UVA)· Ultraviolet B (UVB)· Psoralen and ultraviolet A (PUVA)· Fumarate
    3. Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test taken at screening or baseline for all women, except those who are surgically sterile or at least 1 year postmenopausal.
    4. 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.
    5. Subject or designee must have the ability to reconstitute and inject test article subcutaneously.
    6. Subject is capable of understanding and giving written, voluntary informed consent before study screening.
    7. 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. Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline visit.
    3. Serious infection (requiring parenteral antibiotic and/or hospitalization) within one month prior to screening or baseline visit.
    4. Abnormality in hematology or chemistry profiles at screening or baseline visit: alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 x the upper limit of normal: hemoglobin ≤ 85 g/L (8.5 g/dL); platelet count ≤ 125 x109/L (125,000 cells/mm3); white blood cell count ≤ 3.5 x109/L (3,500 cells/mm3); serum creatinine ≥ 177 µmol/L (2 mg/dL).
    5. Evidence of skin conditions at the time of the screening or baseline visit (eg, eczema) that would interfere with evaluations of the effect of test article on psoriasis.
    6. Receipt of any investigational drug(s) within 3 months of baseline visit.
    7. Receipt of any live (attenuated) vaccine within one month prior to baseline visit.
    8. Receipt of alefacept, efalizumab, anti-CD4 agents, and diphtheria IL-2 fusion protein 6 months prior to baseline visit.
    9. PUVA, UVA, or UVB therapy one month prior to baseline visit.
    10. Receipt of any systemic psoriasis therapy (including methotrexate) or oral or parenteral corticosteroids one month prior to baseline visit.
    11. Topical steroids, topical vitamin A or D analog preparations or anthralin 2 weeks prior to baseline visit (exception – topical steroids at no higher than moderate strength are permitted on the scalp, axillae, groin, but dose and brand must be kept constant for the duration of part A).
    12. Topical cyclosporine, pimecrolimus, and tacrolimus, or calcineurin inhibitors 2 weeks prior to baseline visit.
    13. Body mass index > 38 (see attachment)
    14. Pregnant or breast-feeding women.
    15. Abnormal or clinically significant chest radiograph within 12 months of the screening visit.
    16. Significant concurrent medical conditions at the time of screening or baseline including:· Presence of active infection or any underlying diseases that could predispose subjects to infections.· 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 less than one year prior to baseline visit.· Unstable angina pectoris within 6 months of baseline visit.· Class III or IV congestive heart failure as defined by the New York Heart Association10(see attachment).· Severe pulmonary disease requiring hospitalization or supplemental oxygen therapy.· Diagnosis of multiple sclerosis or any other demyelinating disease.· Uncontrolled insulin-dependent diabetes mellitus.· Any rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or associated syndromes.· Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma).· Open cutaneous ulcers.· Active tuberculosis (follow your country’s guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy).· Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive.· Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
    17. Current or history of psychiatric disease that would interfere with the ability to comply with the study protocol or give informed consent.
    18. History of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
    19. Employment by the investigator or reporting directly or indirectly to the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.

    The secondary efficacy endpoints will include but not limited to:
    · PASI 50
    · PASI 75 (at visit other than week 12)
    · PASI 90
    · PASI score
    · PGA of 0 or 1 (clear or minimal)
    · PGA of 0, 1, 2 (clear, minimal, mild)
    · PGA
    · Patient global assessment of Psoriasis
    · DLQI score
    · DLQI response (proportion of subjects with a DLQI score of 0 or with an improvement of greater than or equal 5 points from baseline)
    · FACIT-F response (proportion of subject with improvement of greater than or equal 3 points from baseline)
    · FACIT-F score·
    EQ-5D score
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The end of the study is the last visit (follow-up) of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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.1.3Elderly (>=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 2006-03-09. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    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 Decision2006-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
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