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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.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2007-004241-15
    Sponsor's Protocol Code Number:IM101-158
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-06-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-004241-15
    A.3Full title of the trial
    A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberIM101-158
    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 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.3.10 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 typeNon Applicabile
    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
    Psoriatic 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 10032451
    E.1.2Term Other rheumatoid arthritis with visceral or systemic involvement
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Double-Blind: To compare the efficacy of 3 regimens of abatacept vs. placebo in a 6-month double-blind study of psoriatic arthritis, as measured by the proportion of subjects achieving an ACR20 response (American College of Rheumatology 20% response) at Day 169. Open-label: To assess the safety and tolerability of abatacept treatment during the open-label extension phase (18 months after the initial 6-month, double-blind period).
    E.2.2Secondary objectives of the trial
    Double blind: 1. To estimate the difference in proportion of subjects achieving an Investigator Global Assessment (IGA) score of clear or almost clear in each of the 3 abatacept arms compared to placebo at Day 169. 2. To estimate the difference in mean percentage change from baseline in each of the 3 abatacept arms compared to placebo in target lesion scores at Day 169. 3. To estimate the difference in mean changes from baseline in physical and mental functions as measured by SF-36 in each of the 3 abatacept arms compared to placebo at Day 169 4. To estimate the difference in proportion of subjects with a diminution in disabilities as measured by HAQ scores between the 3 abatacept arms placebo at Day 169. 5. To describe the safety, tolerability, immunogenicity, and to predict the pharmacokinetics of each of the 3 abatacept arms using population pharmacokinetics (POPPK) methodology. Open-label: See section 2.3.2 of the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent. 2) Target Population a) meet Classification Criteria for Psoriatic Arthritis (CASPAR) (Appendix 3) for a duration of disease at least 3 months; b) prior failure of DMARD therapy (inefficacy or intolerance); if patient had prior failure of methotrexate, s/he must have been on at least 15 mg/week dose for at least 2 months; c) if recent failure of a TNF&#945; blockade compound (inefficacy or intolerance), must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab; d) disease activity as defined by a tender joint count of &#8805; 3, swollen joint count of &#8805; 3 and clinically detectable synovitis at screening and Day 01 (prior to infusion); e) have active psoriasis with a qualifying target lesion &#8805; 2 cm in diameter; f) Must be able to have MRI performed. 3) Age and Sex a) Men and women (not nursing and not pregnant) &#8805; 18 years of age at the time of informed consent; b) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
    E.4Principal exclusion criteria
    1. Sex and Reproductive Status a) 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 dose of investigational product b) Women who are pregnant or breastfeeding, or plan to become pregnant, or to start breastfeeding during the duration of the study c) Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2) Medical History and Concurrent Diseases a) Subjects who are scheduled for or anticipate joint replacement surgery. b) Subjects who have a recent history of clinically significant drug or alcohol abuse c) Concomitant illness that in the opinion of the Investigator, is likely to require systemic glucocorticosteroid therapy during the study (e.g.; moderate to severe asthma) d) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic 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 e) Subjects who are unwilling or unable to have screening performed based on current local or country guidelines/standards to evaluate the presence of cancer (e.g. breast, cervical, colon, prostate, hepatocellular, gastric). f) Subjects with a history or current evidence of malignancies; specifically, subjects with: a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection), or evidence of current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded. Female subjects who have had a manual examination or breast cancer imaging (mammogram, ultrasound, other method) 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 (see Section 6.3.4). g) Subjects at risk for tuberculosis (TB). h) Subjects with any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis and bronchiectasis) i) 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). j) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to signing informed consent k) Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication or who will have need of a live vaccine at any time, during and for 3 months after the duration of the study. 3) Physical and Laboratory Test Findings a) Subjects with Hepatitis B surface antigen. b) Subjects with Hepatitis C antibody-positive subjects who are also RIBApositive or PCR positive. c) Subjects with any of the following laboratory values: i. Hgb < 8.5 g/dL. ii. WBC < 3,000/mm3 (3 x 109/L) iii. Platelets < 100,000/mm3 (100 x 109/L). iv. Serum creatinine > 2 times upper limit of normal. v. Serum ALT or AST > 2 times upper limit of normal. vi. Any other laboratory test results that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. 4) Prohibited Treatments and/or Therapies a) Subjects who are scheduled for or anticipate joint replacement surgery. b) Subjects who have at any time received treatment with CTLA4Ig, BMS-188667 (abatacept). c) Subjects who have received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 01 dose. d) Subjects currently receiving treatment with molecular biologic therapie
    E.5 End points
    E.5.1Primary end point(s)
    Safety outcomes include adverse events, clinically significant changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug. Efficacy: The primary efficacy outcome measure for this study is an ACR20 response at study Day 169. A secondary objective of this study is to estimate the difference in proportion of subjects who achieve an IGA sc ore of clear or almost clear in each of the 3 abatacept arms compared to placebo at Day 169.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Stratificato
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - same IMP used at different dosage
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 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 months6
    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 months6
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 220
    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 Decision2008-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-01-19
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