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    The EU Clinical Trials Register currently displays   30691   clinical trials with a EudraCT protocol, of which   4755   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-017525-19
    Sponsor's Protocol Code Number:77777
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-18
    Trial 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 ConcernedIreland - HPRA
    A.2EudraCT number2009-017525-19
    A.3Full title of the trial
    Abatacept in Psoriasis and Psoriatic Arthritis:
    a single centre, placebo-controlled, crossover study in 15 patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abatacept in Psoriasis and Psoriatic Arthritis:
    a single centre, placebo-controlled, crossover study in 15 patients.
    A.4.1Sponsor's protocol code number77777
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSt. Vincents University Hospital, Department of Rheumatology.
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol Myers Squibb
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Vincents University Hospital
    B.5.2Functional name of contact pointOliver FitzGerald
    B.5.3 Address:
    B.5.3.1Street AddressBone & Joint Unit, Dept of Rheumatology, St Vincents University Hospital,
    B.5.3.2Town/ cityElm Park, Dublin
    B.5.3.3Post code4
    B.5.3.4CountryIreland
    B.5.4Telephone number0035312213142
    B.5.5Fax number0035312214128
    B.5.6E-mailoliver.fitzgerald@ucd.ie
    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 holderName of the MA holder: 9 Bristol Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbr
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for concentrate 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.3.11 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 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 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
    Psoriatic Arthritis
    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
    The primary objective of this study is to assess the change in immunohistochemical markers of synovial inflammation from baseline to 6 months, in patients with active PsA (CASPAR criteria) of > 3 months duration.

    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess:

    1.MRI changes over time in PsA patients on Abatacept.
    2.Articular and skin clinical outcomes over time in patients with PsA on Abatacept.
    3.Skin immunohistologic change, in particular change in T-reg expression comparison between baseline, 1 and 6 months in patients on Abatacept.

    To assess the safety and tolerability of Abatacept in this study population, evaluated by number of adverse events related to drug therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ­Patients must give written informed consent,
    given prior to any study-related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.­
    Patients between the ages 18 and 80 years, with a joint disease onset after 16 years old­ ­
    Patients with active PsA (CASPAR criteria) of > 3 months duration defined by the following criteria: Active arthritis with >3 swollen joints and >3 tender joints considered capable of responding to drug therapy. Should present a clinical synovitis of a knee and have accepted to undergo synovial biopsies ? At least one of the inflamed joints should be a knee joint.§ An evaluable psoriatic skin lesion, diagnosed by a consultant rheumatologist or a dermatologist is not a pre-requisite but where possible such patients will be recruited .
    E.4Principal exclusion criteria
    ·WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to14 weeks after the last dose of tre·atment Female patients who are pregnant or breast-feeding. ·Subjects who meet diagnostic criteria for any other rheumatic disease
    Subjects who are impaired, incapacitated, or incapable of completing study related assessments (including prisoners and patients detained for treatment of psychiatric illness)· Evidence of skin conditions other than psoriasis .· History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the skin).· Subjects with current clinical or laboratory evidence of active tuberculosis .· Latent TB which was not successfully treated.·Active severe infection · Have history of drug (including narcotics) abuse, or current active problems with drug or alcohol abuse· Subjects who have received a previous systemic treatment with biologic DMARDs, including cytokines/anti-cytokines
    E.5 End points
    E.5.1Primary end point(s)
    Response to treatment will be measured by the change in immunohistochemical markers of synovial inflammation from baseline to 6 months in patients with active PsA (CASPAR criteria) of > 3 months duration.
    Using a standard mini-arthroscopic procedure, synovial tissue will be obtained from an inflamed knee joint at 0, 1 and 6 months. Tissue will be embedded in OCT for standard immunohistochemical staining to include cell surface markers (CD3, CD4, CD8, CD68), intracellular T Reg marker FoxP3 and markers of vascularity (Factor VIII). Additional stains for T cell activation markers (CD28) can also added. Staining will be quantified by digital image analysis as outlined below and compared at each time point. All of the synovial immunohistologic analysis will be performed at the end of the study
    Digital image analysis
    Eighteen high power images will be taken per slide for each of the cell specific markers stained. In the case of CD68, the intimal lining layer will be highlighted manually per image, such that staining can be quantified in 2 areas - the intimal lining (LL) and synovial sublining (SL) layers. Analysis will be performed using the Qwin analysis system (Leica, Cambridge, UK). Results will be expressed as the number of positively stained cells/mm2 of tissue for CD3, CD4, CD8, CD68 and Fox P3 and by integrated optical density (IOD) /mm2 for FVIII.
    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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    Last patient last dose.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-01-18. Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 15
    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)
    None
    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 Decision2010-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-11
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