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    Summary
    EudraCT Number:2007-001625-10
    Sponsor's Protocol Code Number:0881X1-4437
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-001625-10
    A.3Full title of the trial
    Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderada

    An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity.
    A.3.2Name or abbreviated title of the trial where available
    Extra
    A.4.1Sponsor's protocol code number0881X1-4437
    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 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
    Artritis reumatoide

    RHEUMATOID ARTHRITIS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the impact of ETN + MTX in comparison with usual treatment on radiographic disease progression at 52 weeks in subjects with moderate RA who failed treatment with MTX.
    E.2.2Secondary objectives of the trial
    To compare the effects of ETN + MTX and usual treatment on clinical outcomes.
    To compare the effects of ETN + MTX and usual treatment on health-related quality of life and dimensions of impact of disease on subjects over 52 weeks.
    To evaluate the safety of the treatment regimen over 52 weeks.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Psychometric properties of synovitis assessed by ultrasonography in rheumatoid arthritis: An ancillary study of the "etanercept versus DMARDs" in moderate RA.
    Version Date: 09-January-2008

    Objective:
    To evaluate the main psychometric properties of the evaluation of synovitis by ultrasonography (US synovitis) in comparison to the evaluation of synovitis by physical examination (clinical synovitis) in rheumatoid arthritis.

    For specific objectives and further details please refere to Attachment 1 of the protocol.
    E.3Principal inclusion criteria
    1- Eighteen years of age or older.

    2- Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.

    3- Active Rheumatoid Arthritis: evidence of clinical signs of joint inflammation / swelling at screening and randomization.

    4- Documented evidence, confirmed by a blinded 3rd party assessor, of at least 1 erosion observed by X-ray (hands or feet) at randomization based on X-ray taken at the screening visit.

    5- Plasma C-reactive protein level of at least 8.0 mg/L in sample taken at the screening visit.

    6- Currently receiving optimized* treatment with MTX but with active disease as defined by a DAS28 score of >=3.2 and <5.1 at both the screening and randomization visits. The erythrocyte sedimentation rate (ESR) value at the screening visit will be used for the DAS 28 calculation at the randomization visit. Have received MTX orally, intramuscularly or SC for at least 4 months before screening with at least 2 months at the highest tolerated dose (not less than 12.5mg/week).

    7- Have received MTX at stable dose for 28 days prior to the screening visit.

    8- In the opinion of the investigator, suitable for continued treatment with MTX at a dose of 12.5 mg/week or greater, but no more than 25 mg/week.

    9- Functional status Class I, II or III as defined by ACR Revised Criteria.

    10- Onset of disease after 16 years of age.

    11- In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits.

    12- Subject is capable of understanding and signing an informed consent form.

    13- Able and willing to self-inject study drug or have a designee who can do so.

    14- Able and willing to take oral medication.
    E.4Principal exclusion criteria
    Previous treatment with ETN, infliximab, adalimumab, other TNF-a inhibitors, anakinra or other biological agents.

    Receipt of any DMARD, other than MTX, within 28 days of the screening visit.
    Unable to tolerate MTX at a minimum dose of 12.5 mg/week orally, intramuscularly or SC.

    Known significant (in the opinion of the investigator) concurrent medical disease including:·
    Cardiac failure.
    History of or current pancytopenia or aplastic anemia.
    Diagnosis of multiple sclerosis or other central or peripheral nervous system demyelinating diseases.
    Current malignancy or an individual history of cancer (other than resected basal cell carcinoma of the skin) within 5 years of the screening visit. · Active infection including known human immunodeficiency virus (HIV) infection and tuberculosis (TB).
    Sepsis, or at risk of sepsis.
    Subjects with signs of immunodeficiency.
    Other current autoimmune connective tissue diseases.
    Significant renal disease in the investigator’s opinion.
    Clinically significant abnormal screening laboratory values in the investigators opinion (based on country-specific standard of care).

    Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.

    Use of any investigational treatment or device within 3 months (or 5 half lives of the treatment, whichever is longer) of the screening visit.

    Concomitant oral corticosteroid >10 mg/day of prednisone or its equivalent at the point of screening (corticosteroid dose must be stable for at least four weeks prior to screening).

    Intra-articular, intravenous, intramuscular or subcutaneous corticosteroid injection within 28 days of the screening visit.

    Active alcoholism and/or substance abuse within one year of the screening visit.

    Conditions requiring initiation of new drug therapy concurrent with entry into this study.

    Receipt of any live viral or bacterial vaccines (attenuated vaccines) within 28 days prior to screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the change from randomization in modified TSS at 52 weeks.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Yes
    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) Yes
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 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 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 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 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 2008-03-24. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 639
    F.4.2.2In the whole clinical trial 700
    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 Decision2008-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-27
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