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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-003768-67
    Sponsor's Protocol Code Number:IM101119
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-07
    Trial results Removed from public view
    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 ConcernedSweden - MPA
    A.2EudraCT number2006-003768-67
    A.3Full title of the trial
    A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate

    Revised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.
    A.4.1Sponsor's protocol code numberIM101119
    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 holderOrencia
    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
    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.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 typeFusion Protein
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    RHEUMATOID ARTHRITIS,NOS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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 primary objective of this study in subjects with active RA and inadequate response to MTX is to assess changes in wrist synovitis as measured by gadolinium-enhanced Magnetic Resonance Imaging (MRI) and using the OMERACT 6 RA MRI score after 4 months of treatment with Abatacept or placebo, on a background therapy with MTX.
    E.2.2Secondary objectives of the trial
    1) To assess in subjects with active RA and inadequate response to MTX changes in
    bone lesions (i.e. bone edema, bone erosions) in hands/wrists (measured by
    gadolinium-enhanced MRI, using the OMERACT 6 RA MRI score) after 4 months of treatment with Abatacept or placebo, on a background therapy with MTX).
    2) To assess in subjects with active RA and inadequate response to MTX changes in
    biochemical markers of bone, cartilage and synovial tissue metabolism at Days 15, 29 and 113 (4 months) after 4 months of treatment with Abatacept or placebo, on a background therapy with MTX.
    3) To assess the safety and tolerability of Abatacept versus placebo in subjects with
    active RA and inadequate response to MTX, on a background therapy with MTX over 4 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed written informed consent
    2) Subjects must meet the criteria of the American Rheumatism Association (1987)
    for the diagnosis of rheumatoid arthritis (Protocol Appendix 1).
    3) Subjects must have a diagnosis of RA greater than 6 months and no longer than 5
    years from the time of initial diagnosis of RA.
    4) Subjects must have a disease activity as defined by a DAS28-CRP > 3.2 or a
    tender joint count of ≥ 6, a swollen joint count of ≥ 6, and a CRP measurement
    greater than the upper limit of normal
    5) Subjects must have clinically detectable synovitis (i.e. “synovial swelling”) of at
    least one wrist at screening and baseline visit (D1, prior to infusion).
    6) Subjects must have at least one erosion present in the hands/wrists and /or feet
    (documented by previous plain radiography) or be anti-CCP positive or be
    rheumatoid factor (RF) positive.
    7) Subjects must have been treated with MTX, on a weekly dose of at least 15 mg or
    a maximum tolerated dose (i.e. 10 mg weekly) for at least 3 months before
    screening. In addition, the dose of MTX must be stable for at least 28 days prior
    to the first study dose (baseline i.e. Day 1).
    8) Subjects must be biologic DMARDs naive (i.e. anti-TNF╬▒, anakinra, rituximab or
    other investigational biologics).
    9) Subjects who consented to have a knee/ankle arthroscopy with tissue and synovial biopsy must have clinically detectable synovitis (i.e. “synovial swelling”) of at
    least one knee/ankle at screening and baseline visit (D1).
    10) At randomization (Day 1), subjects must have the following disease activity :
    a) 6 or more swollen joints (66 joint count) and
    b) 6 or more tender joints (68 joint count) and
    c) CRP greater than the upper limit of normal (result from screening visit sample
    collection).
    11) Drug stabilization requirements (except MTX): Informed consent must be
    signed before making any changes in RA therapy if those changes are solely for
    the purpose of this study.
    a) All DMARDs (except MTX) should be discontinued at least 28 days prior to
    treatment (Day 1).
    -MTX monotherapy: Subjects who are treated only with MTX will not
    require washout.
    -Combination DMARD therapy: Subjects who are treated with MTX in
    combination with another anti-rheumatic treatment (DMARD) will
    require washout.
    b) In the case of leflunomide, the subject can be washed-out with cholestyramine
    according to manufacturer recommendations.
    c) Oral corticosteroid treatment must have been reduced to a maximum equivalent dose of 10 mg prednisone daily for 28 days and stabilized for at least 25 out of 28 days, prior to treatment (Baseline i.e. Day 1).
    12) Osteoporosis treatment:
    Subjects taking treatments for the prevention of glucocorticoid-induced osteoporosis
    (Calcium, vitamin D, Bisphosphonates) will be enrolled as long as their dose has been
    stable for at least 3 months prior to randomization and remains stable during the entire double-blind period. Other concomitant osteoporosis treatments will not be permitted at randomization.
    13) Men and women (not nursing and not pregnant) >= 18 years of age. Women of
    childbearing potential are eligible if they are practicing effective contraceptive
    measures.
    E.4Principal exclusion criteria
    1)WOCBP unwilling or unable to use acceptable method to avoid pregnancy for entire study period & up to 10 weeks after study
    2)WOCBP using prohibited contraceptive method
    3)Pregnant or breastfeeding women
    4)Women with +pregnancy test on enrollment or prior to study drug administration
    5)Contraception for male subjects treated with protocol-permitted concomitant
    medications during study should follow manufacturer’s recommendation for need to use contraception & permissible/recommended method(s)
    6)Subjects who are impaired,incapacitated,or incapable of completing study related assessments
    7)Subjects meeting diagnostic criteria for any other rheumatic disease
    8)previous treatment with approved/investigational biologic RA therapy (infliximab, etanercept,anakinra,adalimumab,rituximab,Abatacept)
    9)Active vasculitis of a major organ system with exception of rheumatoid nodules
    10)current symptoms of severe,progressive, or uncontrolled renal, hepatic,hematological,gastrointestinal,pulmonary,cardiac,neurological,or cerebral disease,or other medical conditions that,in opinion of the investigator,might place subject at unacceptable risk for participation
    11)Female subjects who have had breast cancer screening suspicious for malignancy & in whom possibility of malignancy cannot be reasonably excluded following additional clinical,laboratory or other diagnostic evaluations (Protocol Section 7.3.2.3)
    12)history of cancer within last 5 years (other than nonmelanoma skin cell (NMSC) cancers cured by local resection). Existing NMSC cancers must be removed prior to dosing
    13)Known current metabolic bone disorders other than osteoporosis or low bone mass
    14)Vitamin D deficiency
    15)Clinically significant drug or alcohol abuse
    16)Subjects with any serious bacterial infection within last 3 months, unless treated & resolved with antibiotics, or any chronic bacterial infection
    17)Subjects at risk for TB. Specifically subjects with:
    -History of active TB within last 3 years even if treated
    -History of active TB >3 years ago unless there is documentation
    that prior anti-TB treatment was appropriate in duration & type
    -Current clinical, radiographic or laboratory evidence of active TB
    -Latent TB which was not successfully treated
    18)Subjects with herpes zoster or CMV that resolved less than 2 months prior to signing ICF
    19)Subjects with evidence of active or latent bacterial/viral infections at time of potential enrollment, including subjects with evidence of HIV, HPB or HPC infection detected during screening
    20)Subjects with conditions that preclude accurate DXA measurements
    including:
    -BMI >35 kg/m²
    - Advanced scoliosis or spinal degenerative changes (osteoarthritis, sclerosis)
    -Less than 3 lumbar vertebrae in range L1-L4 which are evaluable by DXA
    interfering conditions include prevalent vertebral fracture, metal implants or spinal
    surgery
    -History of bilateral distal radius fracture
    21)Subject who received live vaccines within 3 months of anticipated
    1st dose of study medication or who will have need of live vaccine at any time
    following Day 1 of study
    22)History of severe or anaphylactic infusion reaction after receiving a biologic
    agent, suspected to be associated with an immune response
    23)Subjects who have at any time received treatment with Abatacept
    24)Subjects who have at any time received treatment with biologic DMARD
    (infliximab, etanercept, adalimumab, rituximab, or any investigational biologic)
    25)Subjects that received treatment with any investigational drug within
    28 days (or< 5 terminal half-lives of elimination) of Day 1 dose
    26) Subjects currently receiving treatment with mycophenolate mofetil (CellCept®),
    cyclosporine, tacrolimus, D-Penicillamine, Cytoxan®, or immunoadsorption
    columns (such as Prosorba columns).
    27)Subjects receiving treatment with following bone active agents, or had previous treatment according to following guidelines:
    -Oral bisphosphonate, vitamin D, or calcium treatments for prevention of
    glucocorticoid-induced osteoporosis if taken for less than 3 months of randomization or bisphosphonate treatment for established osteoporosis
    -Any of following treatments within 3 months of randomization: PTH or PTH
    fragments (teriparatide), systemic hormone replacement therapy, selective
    estrogen receptor modulators (raloxifene, lasofoxifene, bazedoxifene, etc),
    tamoxifen,tibolone,calcitonin,anabolic steroids or testosterone,androgen &
    once weekly dose of >50,000 IU of Vitamin D
    -treatment with fluoride or strontium ranelate
    28)Subjects who received intra-articular injection of steroids within 3 months prior to Screening if injected in >1 joint other than a small joint or in any small joint or within 6 months prior to Screening in the target knee/ ankle for subjects who consented to have a knee/ ankle arthroscopy

    See Section 5.2 of Protocol for additional Exclusion Criteria
    E.5 End points
    E.5.1Primary end point(s)
    Imaging assessments:

    • MRI assessment of the degree of inflammation and structural damage [i.e. synovitis of the most clinically inflamed wrists and bone edema and erosions of the target wrist and metacarpophalangeal (MCP) joints] at baseline (D1), 4 months (end of double-blind treatment period) and 1 year (end of open-label extension) by gadolinium-enhanced MRI, using a centralized reader blinded to sequence and treatment and using the OMERACT 6 RA MRI score.

    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 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 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 Yes
    E.8.1.7.1Other trial design description
    The double-blind phase is followed by an open-label phase of 8 months.
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    LPLV
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 58
    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)
    See Section 4.1 of the protocol
    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 Decision2007-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-25
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