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    Summary
    EudraCT Number:2006-002748-27
    Sponsor's Protocol Code Number:0881A3-403
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-30
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-002748-27
    A.3Full title of the trial
    A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis
    A.4.1Sponsor's protocol code number0881A3-403
    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.3.9.2Current sponsor code0881
    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
    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
    Active, severe and advanced axial ankylosing spondylitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    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 efficacy of etanercept (50mg, once weekly) with that of placebo in adults with active, severe and advanced Ankylosis Spondylitis (as defined by the Modified New York criteria) at week 12.
    E.2.2Secondary objectives of the trial
    To determine:
    􀂙 The efficacy of etanercept compared with that of placebo at weeks 2, 4, 8.
    􀂙 The efficacy of the original etanercept group from baseline to week 24
    􀂙 The change in efficacy of the original placebo group from week 12 to week 24. (the efficacy of the original etanercept group will be analysed separately from the original placebo group even though both groups will be treated with etanercept for the 2nd 12 weeks).
    􀂙 The safety of etanercept in this patient population by analyzing safety data for all patients receiving at least one dose of test article.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Ankylosing Spondylitis (AS), as defined by the Modified New York criteria.
    2. Axial, defined by a score ≥ 30 for the overall level of AS neck, back or hip pain (on a 100 mm VAS) (question 2 of the BASDAI).
    3. Refractory to standard anti-rheumatic treatment (at least 2 NSAIDs at maximum tolerated dose with duration > 3 months and according to the opinion of the investigator).
    4. Active, defined by BASDAI ≥ 40 despite optimal NSAID treatment.
    5. Advanced and severe, defined by the presence of 1 of the 3 following criteria :
    􀂙 2 intervertebral adjacent bridges and/or fusion of the lumbar spine,
    􀂙 3 intervertebral adjacent bridges and/or fusion of the dorsal spine,
    􀂙 2 intervertebral adjacent bridges and/or fusion of the cervical spine.
    6. Between 18 and 70 years of age.
    7. Negative serum pregnancy test taken at screening in all women except those surgically sterile or at least 1 year post-menopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who use contraceptives or whose sexual partners are either sterile or use contraceptives.
    8. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or post-menopausal to use of a reliable method of birth control for the duration of the study.
    9. Ability to reconstitute and self-inject drug or have a designee who can do so.
    10. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific screening procedures are performed.
    11. Ability to store injectable test article at 2°C-8°C.
    E.4Principal exclusion criteria
    1. Previous receipt of etanercept or other TNFα inhibitors.
    2. Use of disease modifying drugs other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
    3. Receipt of multiple NSAIDs at baseline.
    4. Dose of NSAID changed within 2 weeks of baseline evaluation.
    5. Dose of prednisone > 10mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
    6. Abnormality in chemistry or haematologic profiles: white blood cell count ≤ 3.5 x 109/L; haemoglobin ≤ 85 g/L or 5.3 mmol/L; haematocrit ≤ 27%; platelet count ≤ 125 x 109/L; serum creatinine ≥ 175 μmol/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2 times the laboratory’s upper limit of normal.
    7. Significant concurrent medical events :
    • Uncompensated congestive heart failure.
    • Diagnosis of multiple sclerosis or other central demyelinating diseases.
    • Presence or history of confirmed blood dyscrasias.
    • Cancer or history of cancer (other than resected cutaneous basal cell or squamous
    cell carcinoma).
    • Serious infection (infection association with hospitalization and/or intravenous
    antibiotics) within 1 month of test article administration or active infection at
    baseline.
    • Any condition that, in the physician’s judgment, might cause this study to be
    detrimental to the subject.
    • History of HIV+ or TB+ test (follow the local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF α therapy)
    8. Known contraindication or hypersensitivity to etanercept or its excipients.
    9. Pregnant or breast-feeding women.
    10. History of poor compliance.
    11. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
    12. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements or give informed consent.
    13. Receipt of any investigational drug or biological agent within 3 months of screening visit.
    14. Employment by the investigator or reporting directly or indirectly to the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the response BASDAI 50 at week 12 defined as at least a 50 % improvement (decrease) from baseline in the BASDAI.
    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 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 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 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.8.5.1Number 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
    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 months
    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 months4
    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 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 2008-01-30. Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 Decision2008-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-15
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