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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2008-000170-20
    Sponsor's Protocol Code Number:IM119-015
    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:2008-06-03
    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 number2008-000170-20
    A.3Full title of the trial
    A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate the
    Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with Rheumatoid
    Arthritis Having an Inadequate Response to Methotrexate.
    Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)

    Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, para evaluar la eficacia clínica y la seguridad de BMS-582949 administrado por vía oral a sujetos con artritis reumatoide que han mostrado respuesta inadecuada al metotrexato.
    Protocolo Revisado 01, que incorpora la carta administrativa 01 y la enmienda 03 (version 1.0, de fecha 12-Mar-2008).
    A.4.1Sponsor's protocol code numberIM119-015
    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 SponsorBristol Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 No
    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.3.2Product code BMS-582949
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBMS-582949
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)

    sujetos con artritis reumatoide (AR) que estan recibiendo tratamiento de fondo con metotrexato (MTX).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    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 assess the clinical efficacy of BMS-582949 at a dose of 300 mg once a day (qd)
    compared to placebo at 12 weeks as measured by ACR 20 in subjects with RA who are on background therapy with MTX.
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of BMS-582949 in subjects with RA
    • To assess the proportion of subjects who achieve an ACR 50 or ACR 70 response in
    each treatment group
    • To assess the reduction in disease activity over time as measured by the DAS28 and ACR-N over 16 weeks
    • To assess the proportion of subjects achieving a 20 percent change in the assessment of pain, disease activity and fatigue using the American College of Rheumatology (ACR) Disease Activity Visual Assessment Scales (VAS)
    • To assess the percent change in physical function as measured by the disability index of the Health Assessment Questionnaire (HAQ) over 16 weeks of treatment in each treatment group.
    • To determine the trough plasma concentrations of BMS-582949 (Cmin).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    a) Subjects must be able to provide informed, written consent.
    2) Target Population
    a) Subjects must meet the criteria of the American Rheumatism Association (1987)
    for the diagnosis of RA (Arnett et al, 1988) (Appendix 3). The disease must have
    been diagnosed for ≥ 6 months prior to screening.
    b) Subjects must have been taking MTX for at least 3 months at a weekly dose of 7.5
    to 30 mg, inclusive, and at a stable dose for 28 days prior to treatment (Day 1).
    Use of parenteral MTX is acceptable as clinically indicated if subjects cannot
    tolerate or absorb oral MTX.
    c) Subjects must be MTX inadequate responders defined as currently having 6 or
    more swollen joints and 8 or more tender joints at the screening visit (refer to
    Inclusion number 5, disease activity)
    3) Age and Sex
    a) Men and women at least 18 years of age. Men and women of childbearing
    potential are eligible if they are practicing effective contraceptive measures.
    Because subjects are taking background therapy such as methotrexate for
    treatment of RA, which has potential risks associated with its use in pregnancy,
    subjects will be re-advised on the use of reliable contraceptive methods and on the
    potential risks to a pregnancy.
    Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study and for up to 4 weeks after
    the last dose of investigational product in such a manner that the risk of pregnancy
    is minimized.
    4) Concomitant Medication (Anti-rheumatic Treatment)
    a) MTX alone: Subjects who are treated only with methotrexate will not require
    washout.
    b) MTX plus DMARDs other than sulfasalazine or anti-malarials (eg
    hydoxychloroquine, chloroquine): Subjects who are treated with MTX in
    combination with another anti-rheumatic treatment (DMARD) will require
    washout of the other DMARDs.
    c) Drug stabilization requirements
    i) If subjects are taking sulfasalazine and/or anti-malarials, which are allowed as
    concomitant therapy in this study, they must be on a stable dose for 25 out of
    28 days prior to treatment (Day 1).
    ii) All DMARDs (except MTX, sulfasalazine and anti-malarials) must be
    discontinued at least 28 days prior to treatment (Day 1). In the case of
    leflunamide, the subject can be washed out with cholestyramine according to
    manufacturers recommendations.
    iii) Oral corticosteroid treatment must have been reduced to ≤ 10 mg prednisone
    or equivalent per day for at least 14 days and stabilized for at least 11 out of
    14 days prior treatment (Day 1).
    iv) Subjects who have had previous treatment with any
    biologic/immunosuppresant therapy for RA require wash-out for a period of at
    least 28 days or 5 half lives whichever is longer or a minimum of 3 months for
    any biologic agent with an unknown half life, prior to treatment (Day 1).
    v) Subjects requiring NSAIDs must be on a stable dose for at least 14 days prior
    to Day 1 dose.
    d) Prior treatment with up to two anti-TNFα inhibitors will be allowed.
    5) Disease Activity
    a) For subjects receiving MTX alone or MTX plus sulfasalizine and/or antimalarials:
    At the screening visit, subjects must have the following disease activity:
    i) 6 or more swollen joints (66 joint count) and
    ii) 8 or more tender joints (68 joint count) and
    iii) C-reactive protein (CRP) > ULN or erythrocyte sedimentation rate (ESR)
    (Westergren Method) > 28 mm/hr (Both tests are required. Results will be
    used from the screening visit to qualify for the study.)
    b) For subjects receiving MTX plus other DMARDs that require washout:
    At the screening visit, subjects must have the following disease activity:
    i) 6 or more swollen joints (66 joint count) and
    ii) 8 or more tender joints (68 joint count) and
    iii) No restriction on CRP or ESR (Both tests are required)
    IN ADDITION
    All subjects who are receiving other DMARDs plus MTX therapy at the screening
    visit must undergo washout of their other DMARD (other than MTX,
    sulfasalazine, and anti-malarials).
    After washout and within 7 days before randomization on Day 1, subjects
    must have:
    iv) CRP > ULN or ESR (Westergren Method) > 28 mm/hr (Both tests are
    required). Results from this visit will be used to qualify for the study.
    E.4Principal exclusion criteria
    1) Sex and Reproductive Status
    a) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study period and for up to 4 weeks after the last dose of
    investigational product.
    b) Women who are pregnant or breastfeeding
    c) Women with a positive pregnancy test on enrollment or prior to investigational
    product administration.
    d) Men who are unwilling or unable to use an acceptable method of birth control
    for the entire study period.
    2) Medical History and Concurrent Diseases
    a) Any clinically significant acute or chronic illness other than RA that is severe,
    progressive or uncontrolled at the time of screening. This includes any current
    signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
    hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,
    musculoskeletal, genitourinary, or thyroid disease.
    b) Any major surgery within 4 weeks of screening or planned/scheduled surgery
    requiring hospitalization during the time of the study.
    c) Blood transfusion within 4 weeks of screening.
    d) Donation of blood or plasma to a blood bank or in a clinical study within 4 weeks of screening.
    e) Any condition that could impact upon the absorption of study drug. (ie, gastric
    ulcer requiring therapy, gastric stapling, duodenal surgery, malabsorption syndrome).
    f) Subjects (currently or within 3 months) requiring chronic or intermittent medical
    therapy or surgical intervention for gastrointestinal disease including
    gastrointestinal ulceration, chronic heartburn, esophageal reflux, gastric or
    duodenal ulcer and/or gastritis.
    g) Any infection requiring systemic anti-microbial treatment that completed within 4
    weeks of enrollment.
    h) Major infection requiring hospitalization or receipt of intravenous antibiotics
    within 2 months prior to enrollment.
    i) Subjects at risk for tuberculosis (TB).
    j) Have a history of opportunistic infection and/or evidence of active infection
    including but not limited to HIV, Hepatitis B or C viruses.
    k) History of lymphoproliferative disease, including lymphoma, or signs suggestive
    of possible lymphoproliferative disease, such as lymphadenopathy of unusual
    size, location, or clinically significant splenomegaly.
    l) Any known malignancy or history of malignancy within 5 years including
    carcinoma in situ prior to enrollment, with the exception of basal cell or
    squamous cell carcinoma of the skin that has been excised with no evidence of
    recurrence (squamous cell carcinoma of other location is exclusionary).
    m) Subjects who have received treatment with any investigational drug within the
    previous 30 days or 5 half-lives of the Day 1 dose, whichever is greater.
    n) Subjects who have received a live vaccine within 3 months of Day 1 dosing.
    3) Physical and Laboratory Test Findings
    a) Subjects at screening with PT and/or aPTT and/or INR values ≥ 1.05 X ULN.
    b) Subjects at screening with ALT or AST elevations ≥ 1.5 X ULN or with a history
    of frequent or recent ALT or AST elevations are excluded.
    c) Subjects at screening with CK elevations ≥ 2 X ULN or with a history of frequent
    or recent CK elevations are excluded.
    d) Any clinically significant (as determined by the investigator) vital signs and/or physical examination finding.
    e) Positive blood screen for hepatitis B surface Ag and hepatitis C antibody.
    f) Chest radiograph at screening showing evidence of chronic infection, malignancy
    or inflammation.
    g) Screening ECG showing clinically significant abnormalities.
    4) Prohibited Treatments and/or Therapies
    a) Subjects who have received more than two anti-TNF therapies are excluded.
    b) Subjects who require chronic use of proton pump inhibitors (eg omeprazole), H2
    blockers (eg ranitidine, famotidine), based on the medical history, are excluded.
    Proton pump inhibitors and H2 blockers are prohibited within 5 days of Day 1
    (randomization). Antacids are prohibited 3 hours before and after taking study
    drug.
    c) Use of cyclosporin, mycophenolate mofetil or any other immunosuppresants
    (except for MTX, sulfasalazine and anti-malarials).
    d) Use of warfarin or similar agents that would effect coagulation are prohibited.
    e) Use of herbal supplements and dietary over the counter medications (excluding
    MVI).
    5) Other Exclusion Criteria
    a) Prisoners or subjects who are involuntarily incarcerated.
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (eg, infectious disease) illness.
    c) Subjects with any medical or laboratory abnormality, which in the opinion of the
    investigator in consultation with the BMS Medical Monitor could affect subject
    safety, preclude evaluation of response, or render it unlikely that the subject
    would complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint will be the percent of subjects who achieve an ACR 20 response following 12 weeks of treatment and to determine the difference in ACR 20 response between BMS-582949 compared to placebo following 12 weeks of treatment.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) 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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 240
    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 Decision2008-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-30
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