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    Summary
    EudraCT Number:2008-001523-57
    Sponsor's Protocol Code Number:IM101-179
    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:2009-03-17
    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 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
    ND
    A.4.1Sponsor's protocol code numberIM101-179
    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 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 Yes
    D.2.1.1.1Trade name ORENCIA
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB Srl
    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 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.3.10 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.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 Yes
    D.3.11.13.1Other medicinal product typeottenuto da tecnologia del DNA ricombinante
    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
    active rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    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 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 during the study in subjects with active rheumatoid arthritis and inadequate response to methotrexate
    E.2.2Secondary objectives of the trial
    To estimate the predictability of the total PDUS score or its components of the synovitis level of the 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 with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA (1987). 2) RA that has existed for longer than 6 months from the initial diagnosis of RA. 3) Subjects must have disease activity defined by a Disease Activity Score (DAS)28 CRP > 3.2, or a tender joint count of &amp;#61619; 6, a swollen joint count of &amp;#61619; 6, and a C reactive protein (CRP) measurement greater than the upper limit of normal (ULN). 4) Subjects must have been treated with methotrexate in a dose of at least 15 mg for at least 3 months before screening and on a stable dose for the last 28 days before the first dose of abatacept (Day 1). In subjects with intolerance to methotrexate, the dose may be reduced to a maximum tolerated dose (ie, 10 mg weekly) for at least 3 months before screening, and subjects must be on a stable dose for the last 28 days before the first dose of abatacept (Day 1). 5) Subjects must be naive to treatment with biologic disease-modifying anti-rheumatic drugs (DMARDs: anti-TNF&amp;#945;, anakinra, rituximab, or other investigational drug). 6) Subjects must have a total synovitis PDUS score >1 for at least 3 metacarpophalangeal joints at the screening visit and at the baseline visit (Day 1, before infusion).
    E.4Principal exclusion criteria
    1. Women who are unwilling or unable to use an acceptable method to avoid pregnancy, pregnant or breastfeeding. 2. Sexually active fertile men not using an acceptable method to avoid pregnancy if their partners are WOCBP. 3. Subjects who are impaired, incapacitated, or incapable of completing study related assessments. 4. Subjects who meet all diagnostic criteria for any other rheumatic disease 5. Subjects with active vasculitis , 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 study. 6. Female subjects who have had a breast cancer screening that is suspicious for malignancy or history of cancer in the last 5 years. 7. Subjects who clinically, significantly abuse drugs or alcohol. 8. Subjects with evidence of active or latent bacterial or viral infections at the time of potential enrollment, including HIV, herpes zoster or cytomegalovirus 9. Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication. 10. Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection 11. Subjects at risk for tuberculosis (TB). 12. Subjects must not be positive for hepatitis B surface antigen 13. Subjects who are positive for hepatitis C antibody 14. Subjects with any of the following laboratory values: Hemoglobin < 8.5 g/dL, WBC < 3000/mm3, Platelets < 100,000/mm3, Serum creatinine > 2 times the ULN, Serum ALT or AST > 2 times the ULN 15. Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study. 16. Subjects who have at any time received treatment with any investigational drug within 28 days of the Day 1dose. 17. Subjects who have at any time received treatment with abatacept 18. Prisoners or subjects who are involuntarily incarcerated or who are compulsorily detained for treatment of either a psychiatric or physical illness.
    E.5 End points
    E.5.1Primary end point(s)
    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 analyses.
    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.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 Yes
    E.8.1.7.1Other trial design description
    studio multicentrico, multinazionale in aperto
    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 concerned6
    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 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 months2
    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 months2
    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 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 state48
    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 Decision2008-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-28
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