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    Summary
    EudraCT Number:2006-004453-18
    Sponsor's Protocol Code Number:0881A6-409
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-004453-18
    A.3Full title of the trial
    A Randomised, Open-Label Preliminary Study To Assess The Effects Of Etanercept 50 mg Once Weekly For 24 Weeks And Etanercept 50 mg Twice Weekly For 12 weeks Reducing To Etanercept 50 mg Once Weekly For 12 weeks On Nail And Skin Symptoms In Patients With Nail Psoriasis And Plaque Psoriasis.
    A.4.1Sponsor's protocol code number0881A6-409
    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 Pharmaceuticals France
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa 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 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.3.9.1CAS number 185243690
    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 No
    D.3.11.8Extractive medicinal product No
    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 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
    Nail 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 estimate the Nail Psoriasis Severity Index (NAPSI) in the target fingernail for both treatment regimens over 24 weeks.
    E.2.2Secondary objectives of the trial
    · To estimate the overall NAPSI for both treatment regimens over 24 weeks
    · To estimate the proportion of patients achieving a 50% and 75% improvement in NAPSI in the target fingernail and overall NAPSI at 12 and 24 weeks
    · To estimate the Psoriasis Area and Severity Index (PASI) scores over 24 weeks
    · To estimate the proportion of patients achieving a 50% and 75% improvement in PASI scores at 12 and 24 weeks
    · To estimate the Physician Global Assessment (PGA) of Psoriasis over 24 weeks
    · To estimate patient Dermatology Life Quality Index (DLQI) over 24 weeks
    · To estimate Physician and Patient Global Assessment of Nail Psoriasis Disease Activity Visual Analogue Scale (VAS) over 24 weeks
    · To evaluate the safety and tolerability of the treatment regimens over 24 weeks
    · To explore the utility of a novel fingernail grading assessment tool over 24 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.18 years of age or older at time of consent
    2. Active, stable plaque psoriasis defined by the following criteria:
    · Body surface area (BSA) >= 10 % at screening and baseline
    · Or, PASI >10 at screening and baseline
    · Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
    · Or, DLQI > 10 at baseline
    3. Active fingernail psoriasis as defined as target fingernail NAPSI >= 2 and overall NAPSI > 14 – Target nail is defined as the nail with most severe overall grading at baseline.
    4. Failure of at least one systemic psoriasis therapy for nail psoriasis
    5. Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
    6. Able to store injectable test article between 2° and 8°C
    7. Able and willing to self-inject test article or have a designee who can do so.
    8. Women of childbearing potential must have a negative urine pregnancy test at screening. 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.
    9. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article.
    E.4Principal exclusion criteria
    1. Evidence of skin conditions (e.g. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
    2. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive™), efalizumab (Raptiva™), methotrexate, acitretin or any other systemic anti-psoriasis therapy within 3 months of study drug initiation.
    3. Prior exposure to any TNF-inhibitor, including ETN
    4. Severe comorbidities, including but not limited to; uncontrolled insulin dependent diabetes mellitus, uncompensated congestive heart failure (CHF), history of myocardial infarction (MI) within 12 months of screening visit, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease requiring hospitalisation or supplemental oxygen, cancer or history of cancer within 5 years (other than resected cutaneous basal cell or squamous cell carcinoma), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive, systemic lupus erythematosus, history of multiple sclerosis or any other demyelinating disease.
    5. Tuberculosis (TB) infection (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy)
    6. Serious infection (infection associated with hospitalisation and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening
    7. Known history of human immunodeficiency virus (HIV) infection
    8. Any condition that, in the investigator’s judgment, might cause this study to be detrimental to the subject
    9. Receipt of any live (attenuated) vaccine within 28 days of screening visit
    10. Known contraindication or hypersensitivity to etanercept or its excipients.
    11. Pregnant or breast-feeding women.
    12. Reasonable expectation that the subject will not be able to satisfactorily complete the study13. History of or current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
    14. History of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements.
    15. Receipt of any investigational drugs within 28 days of screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in NAPSI for target fingernail over 24 weeks
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    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
    The last follow-up visit of the last randomised subject.
    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 months3
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    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 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 state16
    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 Decision2007-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-03
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