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    Summary
    EudraCT Number:2004-002620-18
    Sponsor's Protocol Code Number:IM101-046
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-002620-18
    A.3Full title of the trial
    A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versus
    Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with
    Undifferentiated Inflammatory Arthritis at High Risk for the Development of
    Rheumatoid Arthritis

    Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;
    and Pharmacogenetics Blood Sample Amendment Number 01
    A.4.1Sponsor's protocol code numberIM101-046
    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.3.1Product nameAbatacept
    D.3.2Product code BMS-188667
    D.3.4Pharmaceutical form Powder for solution for injection
    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 injection
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the proportion of subjects with UA who develop RA as defined by 1987 ARA criteria one year after the start of blinded study medication.
    E.2.2Secondary objectives of the trial
    To assess :
    1) Proportion of subjects with UA who develop RA as defined by 1987 ARA criteria 2 years after the start of blinded study medication.
    2) Proportion of subjects with UA who develop either RA by 1987 ARA criteria or another rheumatic disease at 12 & 24 months.
    3) Degree of synovitis and structural joint damage of the hands (carpal and MCP joints) at 6, 12 & 24 months after the start of study therapy between the 2 treatment groups using MRI imaging.
    4) Proportion of subjects with persistent symptomatic clinical synovitis at 6, 12 & 24 months after the start of medication between the 2 treatment groups & also subjects with a full DAS score of <1.6 at 6,12 & 24 months.
    5) Pharmacodynamic effect of abatacept on serum levels of autoantibodies.
    6) Disease activity over time between the treatment groups using the mean values of the DAS28-CRP score.
    7) Proportion of subjects with a DAS28-CRP score of <2.6 at 6, 12 & 24 months.
    See protocol for additional secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects must have a diagnosis of UA. A subject with UA should have symptomatic
    clinical synovitis of two or more joints and should possess at least one and not more
    than three of the criteria for classification of RA of the American Rheumatism
    Association (1987). See Appendices 1 and 2of the protocol.
    2) Subjects must not meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous).
    3) The subject’s disease duration [defined as the time from the onset of symptoms (joint pain, swelling, or stiffness) of arthritis to enrollment] must be less than 18 months.
    4) Subjects must have be positive for autoantibodies against cyclic citrullinated peptides by ELISA.
    5) Men and women, at least 18 years old. WOCBP are eligible if they are practicing effective contraceptive measures.

    WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last infusion of abatacept in such a manner that the risk of pregnancy is minimized.
    E.4Principal exclusion criteria
    1) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study period and for up to 10 weeks after the last infusion of abatacept.
    2) Women who are pregnant or breastfeeding or with a positive pregnancy test on enrollment or prior to study drug administration.
    3) Subjects who are impaired, incapacitated, or incapable of completing study related assessments.
    4) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous).
    5) Undifferentiated Arthritis duration of greater than 18 months.
    6) Subjects who have previously received treatment with an approved biologic RA therapy (infliximab, etanercept, anakinra, adalimumab).
    7) Subjects with active vasculitis of a major organ system.
    8) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
    Concomitant medical conditions that, in the opinion of the investigator, might place
    the subject at unacceptable risk for participation in this study.
    9) Female subjects, who have not had age and/or risk factor appropriate breast cancer screening (as defined by published guidelines and/or local standards endorsed by the national cancer or medical society and/or the Ministry of Health), or who have had a breast cancer screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations (Please refer to Section 7.3.2).
    10) Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing.
    11) Subjects who have clinically significant drug or alcohol abuse.
    12) Subjects with any serious acute bacterial infection (such as pneumonia or
    pyelonephritis unless treated and completely resolved with antibiotics).
    13) Subjects with severe chronic or recurrent bacterial infections (such as recurrent
    pneumonia, chronic bronchiectasis).
    14) Subjects with active tuberculosis (TB) requiring treatment within the previous
    3 years. Subjects with a positive PPD at screening will not be eligible for the study
    unless active TB infection has been ruled out, and they have a negative chest x-ray at enrollment. A PPD response that is equal to or greater than 10 mm should be
    considered a positive test, although a lower threshold (5 mm) may be applied as
    determined by the clinical circumstance and investigator according to published
    guidelines and/or local standards endorsed by the medical society. (Section 7.3.2)
    15) Subjects with herpes zoster that resolved less than 2 months prior to enrollment.
    16) 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) infection.
    17) Subjects who have at any time received treatment with CTLA4Ig, or abatacept.
    18) Subjects who have received treatment with any investigational drug within 28 days(or less than 5 terminal half-lives of elimination) of the Day 1 dose.
    19) Subjects currently receiving treatment with immunoadsorption columns (such as
    Prosorba columns), mycophenolate mofetil (CellCept), cyclosporine,
    D-Penicillamine, or calcineurin inhibitors.
    20) Treatment with a DMARD prior to enrollment in the study with exception of the following: Subjects may have received chloroquine, hydroxchyloroquine, or sulfasalazine for <14 days, if the drug is discontinued at least 7 days prior to enrollment in the study.
    21) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the study will be the proportion of subjects with a diagnosis of RA by 1987 ARA criteria at 12 months.

    Secondary efficacy outcome measures include the proportion of subjects with a diagnosis of RA by 1987 ARA criteria at 24 months, the proportion of subjects who develop either RA by 1987 ARA criteria or another rheumatic disease at 12 and 24 months, the proportion of subjects with persistent symptomatic clinical synovitis at 6, 12, and 24 months, the mean DAS28-CRP score at 6, 12, and 24 months, the proportion of subjects with a DAS28-CRP score of <2.6 at 6, 12, and 24 months, titers of RA-related autoantibodies, and inflammation and structural damage (degree of synovitis, erosions and joint space narrowing) on MRI using a centralized reader blinded to sequence and treatment.

    Subject reported outcomes will include the HAQ and SF-36. The changes in core components of the ACR RA composite variable will be assessed over time between the two treatment groups as a tertiary objective.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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 EEA16
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 250
    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 Decision2005-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-04
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