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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   43691   clinical trials with a EudraCT protocol, of which   7244   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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    EudraCT Number:2008-001523-57
    Sponsor's Protocol Code Number:IM101179
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2008-001523-57
    A.3Full title of the trial
    Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberIM101179
    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.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.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. name Orencia
    D. of the Marketing Authorisation holderBristol-Myers Squibb Company
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameAbatacept (IV)
    D.3.2Product code BMS-188667
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAbatacept
    D.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeBMS-188667
    D.3.9.3Other descriptive nameCTLA4Ig
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Yes
    D. medicinal product typeFusion protein
    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
    Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate

    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
    The main objective is to assess the occurrence of early signs of response to abatacept with background methotrexate, as defined by improvement of synovitis measured by Power Doppler Ultrasonography of the affected metacarpophalangeal joints (2-5th MCPs only) during the study in subjects with active rheumatoid arthritis and inadequate response to methotrexate.
    E.2.2Secondary objectives of the trial
    The second objective is to estimate the predictability of the global PDUS score or its components of the synovitis level of the 2-5th MCP joints to disease activity measured by DAS28-CRP or DAS28-CRP-derived criteria at specified timepoints during the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Subjects must meet the 1987 criteria of the American Rheumatism Association
    for the classification of RA
    2) Subjects must have had a diagnosis of RA for more than 6 months from the time
    of the initial diagnosis of RA.
    3) Subjects must have disease activity defined by a DAS28-CRP > 3.2, or all of the following criteria must be met: tender joint count of ≥ 6, a swollen joint count of ≥ 6, and a C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN).
    4) Subjects must have a total synovitis PDUS score >1 for at least 2 MCPs (MCP2-5)and a total synovitis PDUS score>1 for at least one other MCP(MCP2-5)at the
    screening visit and at the baseline (Day 1, before infusion) visit.
    5) Subjects must have been treated with methotrexate of at least 15 mg for at least
    3 months before Day1 and on a stable dose for the last 28 days before Day1. In subjects with intolerance to methotrexate, the dose could be reduced to a maximum tolerated dose (ie, 10 mg weekly) for at least 3 months before Day1 and on a stable dose for the last 28 days before the Day1.
    6) Subjects who received combination therapy (methotrexate plus another
    nonbiologic DMARD) before study entry require washout. These subjects must
    not be treated with any background nonbiologic DMARD other than methotrexate
    for at least 28 days before treatment (Day 1). In the case of leflunomide, the
    washout period is 8 weeks unless subjects take cholestyramine according to the
    manufacturer’s recommendation.
    7) Subjects who have received oral corticosteroids during the 28 days before
    treatment (Day 1) must have been on a stable dose for at least 25 out of 28 days
    and on a total dose of ≤ the equivalent of 10 mg prednisone/day(see Section
    8) Subjects must be naive to treatment with biologic DMARDs (infliximab, anakinra, etanercept, adalimumab, rituximab, tocilizumab, golimumab, certolizumab and any investigational biologic DMARD).
    E.4Principal exclusion criteria
    1)Subjects who are impaired, incapacitated, or incapable of completing study related
    2) Subjects who meet all diagnostic criteria for any other rheumatic disease (eg,
    lupus erythematous).
    3) Subjects who underwent previous MCP arthroplasty, have such a procedure
    scheduled, or anticipate the need for such a procedure during the study.Subjects with other underjoint arthroplasties, other than MCPs are allowed in the study.
    4) Subjects with active vasculitis of a major organ system, with the exception of
    rheumatoid nodules.
    5) Subjects with current symptoms of severe, progressive, or uncontrolled renal,
    hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RA and which, in the opinion of the
    investigator, might place a subject at unacceptable risk for participation in the
    6) Female subjects who have had a breast cancer screening that is suspicious for
    malignancy and in whom the possibility of malignancy cannot be reasonably
    excluded by additional clinical, laboratory, or other diagnostic evaluations
    7) Subjects with a history of cancer in the last 5 years, other than non-melanoma
    skin cell cancers cured by local resection or carcinoma in situ. Existing nonmelanoma
    skin cell cancers should be removed, the lesion site healed and residual
    cancer ruled out before administration of the study drug.
    8) Subjects who clinically, significantly abuse drugs or alcohol.
    9) Subjects with evidence (as assessed by the investigator) of active or latent
    bacterial or viral infections at the time of potential enrollment, including subjects
    with evidence of human immunodeficiency virus (HIV).
    10) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than
    2 months before the informed consent document was signed.
    11) Subjects who have received any live vaccines within 3 months of the anticipated
    first dose of study medication.
    12) Subjects with any serious bacterial infection within the last 3 months, unless
    treated and resolved with antibiotics, or any chronic bacterial infection (eg,
    chronic pyelonephritis, osteomyelitis or bronchiectasis).
    13) Subjects at risk for tuberculosis (TB). Specifically excluded from this study will
    be subjects with:
    • A history of active TB within the last 3 years, even if it was treated.
    • A history of active TB greater than 3 years ago, unless there is
    documentation that the prior anti-TB treatment was appropriate in duration
    and type.
    • Current clinical, radiographic, or laboratory evidence of active TB.
    • Latent TB that was not successfully treated (≥ 4 weeks).
    14) Subjects must not be positive for hepatitis B surface antigen.
    15) Subjects who are positive for hepatitis C antibody if the presence of hepatitis C
    virus was also shown with polymerase chain reaction or recombinant immunoblot
    16) Subjects with any of the following laboratory values
    • Hemoglobin < 8.5 g/dL
    • WBC < 3000/mm3 (< 100 x 10 9/L)
    • Platelets < 100,000/mm3 (< 100 x 10 9/L)
    • Serum creatinine > 2 times the ULN
    • Serum ALT or AST > 2 times the ULN
    17) Any other laboratory test results that, in the opinion of the investigator, might
    place a subject at unacceptable risk for participation in the study.
    18) Subjects who have at any time received treatment with any investigational drug
    within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1
    19) Subjects who have at any time received treatment with abatacept (BMS-188667
    or CTLA4Ig).
    20)Subjects who received an intra-articular injection of corticosteroids in the MCP joints within the last 3 months of Day1 (before first infusion of abatacept).
    21)Women who are pregnant or breastfeeding.
    22) Women with a positive pregnancy test on enrollment or before administration of
    E.5 End points
    E.5.1Primary end point(s)
    Study Assessments and Primary Endpoints:
    • Efficacy and safety parameters will be assessed at each predefined timepoint: Days 1, 7, 15, 29,
    43, 57, 85, 113, 141, 169, and 199.
    • Primary efficacy assessments consist of Power Doppler Ultrasonography (PDUS) MCP joint
    assessments and the DAS28-CRP. The global PDUS score and DAS28-CRP will be calculated at
    all visits during 6 months of treatment.
    • Safety will be assessed throughout the study via physical examinations; monitoring of vital signs,
    adverse events, and serious adverse events; pregnancy tests; and blood chemistry and hematology
    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. 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) No
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    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 Decision2010-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-28
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