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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   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:2009-012520-84
    Sponsor's Protocol Code Number:0881A1-3338-WW
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-012520-84
    A.3Full title of the trial
    A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code number0881A1-3338-WW
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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
    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*BB SC 4FL 25MG 1ML+4SIR
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH LEDERLE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.10 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 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
    Extended Oligoarticular Juvenile Idiopathic Arthritis (JIA) Enthesitis-Related Arthritis (ERA) Psoriatic Arthritis (PsA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003246
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA. Part 2: To assess the long-term safety of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA.
    E.2.2Secondary objectives of the trial
    Part 1: To assess the effect of etanercept on safety and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA. Part 2: To assess the effect of etanercept on clinical benefit and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female subjects must have met ILAR criteria for diagnosis of 1 of the following JIA subtypes (see Attachment 1 for ILAR criteria) before the screening visit and must be within the specified age range at the time of the screening visit: extended oligoarticular JIA between the ages of 2 and 17 years. ERA between the ages of 12 and 17 years. PsA between the ages of 12 and 17 years. 2.At both the screening and baseline visits, the following criteria must be met for the relevant JIA subtype: Extended oligoarticular JIA: &#8805; 2 active joints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness). A history of intolerance or an unsatisfactory response to at least a 3-month course of at least 1 disease-modifying antirheumatic drug (DMARD) at an adequate dose. PsA: &#8805; 2 active joints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness). A history of intolerance or an unsatisfactory response to at least a 3-month course of at least 1 DMARD at an adequate dose. ERA: 2 active joints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness) A history of intolerance or an unsatisfactory response to at least 1 of the following: at least a 1-month course of at least 1 nonsteroidal anti-inflammatory drug (NSAID) at an adequate dose OR at least a 3-month course of at least 1 DMARD at an adequate dose. 3.Subjects taking hydroxychloroquine, sulphasalazine, or methotrexate (MTX) must have been receiving these for at least 3 months before the baseline visit. Only 1 DMARD is to be taken throughout the study and the dose must be held stable for at least 8 weeks before the baseline visit. 4.All male and female subjects who, in the opinion of the investigator are biologically capable of having children, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 30 days after the last dose of investigational product. Female subjects who, in the opinion of the investigator, are biologically capable of having children must have a negative urine pregnancy test at screening and baseline (day 1) before administration of investigational product. 5.Either the subject or an available adult must be capable (according to the investigators judgment) of reconstituting and administering injections of subcutaneous (SC) etanercept. 6.The parent or legally authorized representative/guardian of the subject must be able to read and complete the protocol-specified efficacy assessments.
    E.4Principal exclusion criteria
    1.Subjects with systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria. 2.Subjects positive for HLA-B27 (PsA and extended oligoarticular subtypes only) or immunoglobulin M (IgM) rheumatoid factor (RF) at the screening visit. 3.Subjects with active uveitis within 6 months of the baseline visit. 4.Subjects with other rheumatic diseases including but not limited to Lyme disease, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or reactive arthritis, overlap syndrome (eg, Sharps syndrome), or Reiters syndrome. 5.Subjects with guttate, pustular, or erythrodermic psoriasis. 6.Prior treatment with any biologic drugs, including TNF inhibitors, abatacept, rituximab, and tocilizumab. 7.Receipt within 6 months before the baseline visit: Immunosuppressive drugs (excluding corticosteroids) (eg, cyclophosphamide). Leflunomide. 8.Receipt within 3 months before the baseline visit: Nonbiologic DMARDs other than hydroxychloroquine, sulphasalazine, MTX, or those not listed under other exclusion criteria. Any investigational nonbiologic drugs or devices. Any live (attenuated) vaccines. 9.Receipt within 4 weeks before the baseline visit: Ultraviolet A (UVA), ultraviolet B (UVB), or psoralen + UVA (PUVA) therapy for psoriatic lesions. 10.Receipt within 2 weeks before the baseline visit: More than 1 NSAID, or a change in the dose or type of the NSAID, or an NSAID dose greater than the maximum recommended dose. More than 0.2 mg/kg/day or > 10 mg/day, whichever is less, of oral prednisone or equivalent, or a change in the dose of prednisone or its equivalent. Receipt of intra-articular or soft tissue corticosteroid injection or bolus intramuscular (IM) or intravenous (IV) treatment with corticosteroids. Topical steroids, oral retinoids, topical vitamin A or D analog preparations or anthralin for psoriatic lesions (exception topical therapies are permitted on the scalp, axillae, and groin at low to moderate strength; the dose and type must be held stable for at least 2 weeks before the baseline visit). 11.Any major illness/condition or evidence of unstable clinical condition (eg, cardiovascular [including congestive heart failure], cerebrovascular, neurologic, metabolic, immunologic, infectious, hepatic, renal condition, uncontrolled diabetes mellitus or hypertension), or any serious disorder (eg, current or history of alcohol or drug abuse, current or history of psychiatric disease) that, in the investigators judgment, will substantially increase the risk associated with the subjects participation in and completion of the study, or could preclude the evaluation of the subjects response, or interfere with the subjects ability to give informed consent. 12.Pregnant or breastfeeding female subjects. 13.Cancer or history of cancer. 14.History of blood dyscrasias. 15.History of Macrophage Activating Syndrome (MAS). 16.History of demyelinating diseases (eg, multiple sclerosis or optic neuritis). 17.Documented immunodeficiency disease, including subjects with known human immunodeficiency virus (HIV) at the time of the screening visit. 18.Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and/or hepatitis C virus (HCV). 19.History of drug-induced liver injury, liver cirrhosis or fibrosis at any time before the baseline visit. 20.Any of the following laboratory abnormalities at screening: a.Hemoglobin < 8.5 g/dL (SI units: < 85 g/L) b.White blood cell (WBC) count < 3.50 x 103/mm3 (SI units: < 3.50 x 109/L) and neutrophils < 1 x 109 /L c.Platelets < 125,000/mm3 or &#8805; 1,000,000/mm3 (SI units: < 125 x 109/L or &#8805; 1,000 x 109/L) d.Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) > 1.5 x upper limit of normal (ULN) Screening laboratory tests with abnormal results ...
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of Clinical Benefit in the Combined Population: The main endpoint for the combined population is the proportion of subjects meeting the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) criteria at week 12, defined as > 30% improvement in at least 3 of 6 of the following variables: 1.Physicians Global Assessment (PGA) of Disease Activity on a 21-circle visual analogue scale (VAS) 2.Parent/Patient Global Assessment on a 21-circle VAS 3.Childhood Health Assessment Questionnaire (CHAQ) 4.Number of active joints (defined as joints that are swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness) 5.Number of joints with limited range of motion 6.Laboratory measure of inflammation (CRP) With worsening > 30% in no more than 1 of these variables. Additional assessments of clinical benefit in the combined population will be assessed at screening, baseline, weeks 4, 8, 12, 24, 36, 48, 60,72, 84, and 96, or upon early withdrawal, unless otherwise indicated: ACR Pedi 30 at all timepoints other than week 12 ACR Pedi 50, 70, 90, and 100 Individual components of the ACR Pedi 30 Pain Assessment on a 21-circle VAS Duration of morning stiffness Disease status, where inactive disease is defined as no joints with active arthritis, a normal CRP, and a PGA of disease activity of 0 on a 21-circle VAS.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicita`: per verificare la presenza di anticorpi anti-etanercept
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) 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 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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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 Yes
    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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    minori di 18 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 87
    F.4.2.2In the whole clinical trial 100
    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 Decision2010-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-30
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