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    Summary
    EudraCT Number:2007-003994-18
    Sponsor's Protocol Code Number:EHOA
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-04-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-003994-18
    A.3Full title of the trial
    EHOA: Etanercept as treatment for Hand OsteoArthritis

    A randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy and the structure modifying properties of etanercept 50/25 mg subcutaneous weekly in patients with eroive osteoarthritis of the interphalangeal finger joints
    A.3.2Name or abbreviated title of the trial where available
    EHOA
    A.4.1Sponsor's protocol code numberEHOA
    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 SponsorMedizinische Universität Wien, Universitätsklinik für Innere Medizin III/Rheumatologie
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Pharmaceuticals
    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 nameetanercept
    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.3.11 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) Yes
    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 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
    Patients with erosive inflammatory osteoarthritis of the interphalangeal joints
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10016686
    E.1.2Term Finger osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate the efficacy of a treatment with etanercept 50 mg sc once weekly during 24 weeks versus placebo, followed by 25 mg sc once weekly for 26 weeks versus placebo as a therapeutic intervention in erosive interphalangeal joint osteoarthritis.

    The primary objective is to assess the effect of etanercept on joint pain over 24 weeks in subjects with inflammatory and erosive OA of the hand.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    -To assess the effect of etanercept on joint pain over 12 weeks in subjects with inflammatory and erosive OA of the hand.
    -To assess the effect of etanercept on joint pain over 52 weeks in subjects with inflammatory and erosive OA of the hand.
    -To assess the effect of etanercept on OA specific and generic physical function and joint stiffness over 12, 24 and 52 weeks in subjects with inflammatory and erosive OA of the hand.
    -To assess the effect of etanercept on patient global assessment over 24 and 52 weeks in subjects with inflammatory and erosive hand OA.
    -To assess the tolerability and safety of etanercept over 24 and 52 weeks in subjects with inflammatory and erosive OA of the hand.
    -To assess the effect of etanercept on clinical, laboratory, and imaging assessments over 24 and 52 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Males and females > 18 years of age. 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 30 days after the last dose of test article.
    •Subjects with hand OA showing or having suffered from transient inflammatory attacks of the IPJs characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA.
    •At least 4 OA nodes of the IPJs, e.g. Heberden's and Bouchard's nodes at screening
    •At least 1 inflamed IP (slight swelling or erythema) at screening
    •At least 1 IP with positive power Doppler signal at ultrasound
    •Subjects with hand OA in which at least 1 IPJ has the typical appearance on radiograph of an “E” phase joint as defined by the criteria mentioned above.
    •OA pain at rest at screening visit of > 30 mm on the VAS
    •Flare of OA pain with activity at baseline (after NSAID washout) as defined by: >50mm on the VAS
    •Worsening by > 20 mm on the VAS compared to screening
    •Use of NSAIDs to treat finger joint pain at least 5 days per week with a stable dose for at least 4 weeks
    •Inadequate response to at least 1 NSAIDS other than the current NSAID.
    •Able and willing to self-administer sc injections or have available a suitable person to administer sc injections
    •Able and willing to give written informed consent and to comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    •Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer.
    •Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis or positive rheumatoid factor or positive anti-CCP antibodies, spondylarthropathy, psoriatic arthritis, haemochromatosis, gout, chondrocalcinosis or other auto-immune diseases
    •Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, corticosteroids, tetracyclines and estrogens is allowed.
    •Prior use of any immunomodulating drug with possible effects on pro-inflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, d-penicillamin, anti-malarials, cytotoxic drugs, TNF blocking agents
    •If the patient is of child-bearing age, he/she must use effective means of contraception during the study.
    •Patient who has a known blood coagulation disorder
    •History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia, with no recurrence within the last two years
    •Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), active inflammatory bowel disease, recent stroke (within three months), chronic leg ulcer and any other condition (e.g,. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
    •Positive serology for hepatitis B or C indicating active infection.
    •History of positive HIV status.
    •Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
    •Female subjects who are breast-feeding.
    •History of clinically significant drug or alcohol abuse in the last year.
    •Previous diagnosis or signs of central nervous system demyelinating diseases (e.g., optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).
    •Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis
    •Evolutive tuberculosis or other severe infections like sepsis and opportunistic infections
    •Patients with latent TB (positive PPD skin and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB, e.g. previous exposure to TB, who have not initiated a TB prophylaxis prior to the first etanercept treatment.
    •Current or prior history of blood dyscrasias. Abnormal safety baseline blood test e.g. hemoglobin ≤85 g/L; hematocrit ≤27 %; platelet count ≤125 x 109 /L; white blood cell count ≤3.5 x 109 /L; serum creatinine ≥175 µmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≥2 times the laboratory’s upper limit of normal.
    •Pre-existing or recent onset CNS demyelinating disease.
    •Uncontrolled conditions, e.g., diabetes mellitus, hypertension (defined as screening systolic blood pressure > 160mm Hg or screening diastolic blood pressure > 100 mm Hg), severe pulmonary disease requiring hospitalization or supplemental oxygen.
    •Latex sensitivity.
    •Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
    •Employment by the investigator or reporting directly or indirectly to the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    •Patient assessment of joint pain based on a 100 mm VAS scale
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 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
    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 years2
    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 years2
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected normal treatment
    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 Decision2009-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
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