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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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:2004-004051-19
    Sponsor's Protocol Code Number:IM101-042
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-03-29
    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 number2004-004051-19
    A.3Full title of the trial
    A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to
    Evaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of Oral
    Glucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosus
    and the Prevention of Subsequent Lupus Flares.
    Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific.
    A.4.1Sponsor's protocol code numberIM101-042
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    SYSTEMIC LUPUS ERYTHEMATOSUS, 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
    The primary objective for this study will be to assess the proportion of subjects with a new clinical flare of SLE (BILAG “A” or “B”) during the 1 year double-blind treatment period, comparing abatacept with placebo on a background of tapering glucocorticosteroids.
    E.2.2Secondary objectives of the trial
    1) Assess the proportion of subjects with a new clinical flare of SLE (BILAG “A” or
    “B” within the initial 6 months of the double-blind trt period.
    2) Evaluate the proportion of subjects who during the study experienced a BILAG “A”
    or “B”) flare and/or had an increase in prednisone or prednisone equivalent dosage for clinical re-activation of SLE that did not meet BILAG “A” or “B” criteria for flare of SLE.
    3) Assess total number of BILAG “A” and BILAG “B” flares and evaluate the time to occurrence of a new clinical flare of SLE in the two trt groups.
    4) Assess proportion of subjects in each study arm who have no flares of their lupus for at least 6 consecutive months.
    5) Assess SLICC/ACR Damage Index at one year compared with baseline for the two
    trt groups.
    6) Assess total exposure to glucocorticosteroids in the two groups, as measured by total prednisone or prednisone equivalent“area under the curve” (AUC).
    7) Assess the average glucocorticosteroid dose at flare.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Subjects must have SLE as defined by meeting 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus (Appendix 1), either sequentially or coincident. The 4 criteria need not be present at study entry, but have occurred at some time during the course of the disease.
    2) Within 28 days of the screening visit, subjects must have at least one of the following flare manifestations of SLE, as defined by the BILAG criteria as modified for use in this study. The flare manifestation may represent the initial activity within that organ system or may be a recurrence of activity in an organ system previously affected. [the subject may be experiencing other BILAG “A” or “B” features of lupus as well (other than renal or central nervous system which are specifically excluded from entry), but features other than those specified below are not sufficient for entry into the study]:

    a) Active mucocutaneous discoid lesions:
    i) “A”: severe active facial and/or extensive discoid lesions (> 2/9 of body surface area), scarring or causing disability recorded as > 1.
    ii) “B”: localized active discoid lesions (< 1/9 total body surface area), including lupus profundus recorded as > 1. The skin lesions must be actively inflamed; they cannot be solely chronic changes, e.g. scar with depigmentation. In order to satisfy inclusion rules, the currently active lesions cannot represent ongoing chronic and continuous activity - they must constitute a flare, either newly inflamed or previously inflamed but quiescent for at least 3 months.

    b) Active polyarthritis:
    i) “A”: severe polyarthritis as recorded as > 1 with loss of function (not responsive to steroids less than 10 mg per day, antimalarials, NSAIDs)
    ii) “B”: Arthritis as recorded as > 1: active joint inflammation without loss of functional range of motion. At least 3 actively inflamed joints--swollen, tender, erythematous--not
    isolated Jaccoud arthropathy although the presence of Jaccoud arthropathy in a subject with active inflammation will not preclude study entry. The inflamed joints cannot have been chronically and continuously inflamed- they must constitute a flare, either newly inflamed or previously inflamed but quiescent for at least 3 months.

    Activity in an organ system that was either minimally or not active for at least 3
    months:
    i) now BILAG A in an organ system that was BILAG B, C, D, or E, OR
    ii) now BILAG B in an organ system that was previously BILAG C, D, or E

    c) Active serositis (pleuritis/pericarditis):
    i) “A”: Symptomatic effusion recorded as > 1 plus two other criteria listed below > 1 or four of the following criteria listed below recorded as > 1: pleuropericardial pain; dyspnea; friction rub; chest x-ray revealing pleural or pericardial effusion; electrocardiogram changes of pericarditis; or cardiac arrhythmia including tachycardia > 100 beats per minute in the absence of fever.
    ii) “B”: Two of the following criteria listed below each recorded as > 1: pleuropericardial pain; dyspnea; friction rub; chest x-ray revealing pleural or pericardial effusion; electrocardiogram changes of pericarditis; or cardiac arrhythmia including tachycardia > 100 beats per minute in the absence of fever.

    Although commonly used in some practices, echocardiographic confirmation of the presence of pericardial disease is not considered a BILAG criterion and therefore cannot be substituted for any of the criteria noted above.
    E.4Principal exclusion criteria
    1) Women who are pregnant or breast-feeding.
    2) Women with a positive pregnancy test on enrollment or prior to study drug administration.
    3) 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 study medication.
    4) Contraception for male subjects treated with any protocol-permitted non-biologic steroid sparing agent during the study should follow the recommendation of that steroid sparing agent’s manufacturer for method to be used. Males unwilling or unable to follow these recommendations will be excluded.
    5) Treatment of current SLE flare with corticosteroids for more than 14 days prior to randomization, or treatment of the flare at any time with a dose 30 mg (prednisone or prednisone equivalent) per day.
    6) Active anti-phospholipid antibody syndrome, (i.e. recent untreated thromboses, cerebral or pulmonary emboli, pregnancy loss, pleurisy due to thromboembolic phenomena) as the sole or primary feature of their SLE or SLE-like syndrome should be excluded. However, subjects currently controlled with anti-coagulation therapy, who have no disease activity may be included in the study.
    7) Subjects with drug-induced SLE, rather than “idiopathic” SLE.
    8) Subjects with other autoimmune disease as a main diagnosis other than SLE (e.g.; RA, MS).
    9) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, non-SLE pulmonary, non-SLE cardiac, neurological, or cerebral disease; pulmonary and/or cardiac manifestations of SLE shall not constitute an exclusion to study entry. Concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.
    10) Concomitant illness that in the opinion of the investigator, is likely to require additional systemic glucocorticosteroid therapy during the study, (e.g.; asthma) is exculsionary.
    11) Female subjects with a breast cancer screening that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
    12) Subjects with a history of cancer within the last five years (other than nonmelanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to randomization (Day 1 treatment). Carcinoma in situ, treated with definitive surgical intervention, is allowed.
    13) Subjects who have a history of clinically significant drug or alcohol abuse. Subjects currently taking methotrexate who admit to consumption of more than an average of 1 alcoholic drink per day.
    14) Subjects with any serious bacterial infection (such as pneumonia, renal infection and sinusitis), unless treated and resolved with antibiotics or chronic bacterial infection (such as pyelonephritis, osteomyelitis and lung infection with bronchiectasis) in the previous 3 months.
    15) The following subjects will not be allowed in this study:
    -Subjects with current clinical or laboratory evidence of active or latent tuberculosis (TB).
    -Subjects with a history of active TB treated within the last 3 years.
    16) Subjects with herpes zoster that resolved less than 2 months prior to enrollment.
    17) 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.
    18) Subjects currently on hydroxychloroquine or chloroquine with evidence of retinopathy within 6 months of enrollment or who have had no ophthalmologic evaluation within one year of enrollment and will not have this examination done.
    19) Subjects who have at any time received treatment with CTLA4Ig or abatacept.
    20) 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.
    21) Subjects who have at any time received treatment with rituximab.
    22) Subjects who have received treatment with cyclophosphamide within the 1 year prior to enrollment. Any subject who has received prior cyclophosphamide and now has non menstrual hematuria will be excluded from the study.
    23) Subjects who have received treatment with cyclosporine, another calcineurin inhibitor or other immunosuppressive medication (oral or topical) within 3 months of enrollment.
    24) Subjects who have received treatment with gamma globulin within 4 months of enrollment.

    Please refer to the section 5.2. of the protocol for additional exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the occurrence of SLE disease flare during the 12 month treatment period. The occurrence of flare will be summarized as the proportion of subjects in each of the two treatment arms to experience one or more flares. The treatment difference will be provided along with its 95% confidence interval. In addition, the hazard ratio and its 95% confidence interval, adjusted for the randomization strata using Cochran-Mantel-Haenszel (CMH) methods, will be summarized. Subjects whose active manifestations of lupus at study entry do not remit within 8 weeks of randomization will also be counted as having experienced a lupus flare.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    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 2005-03-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 143
    F.4.2.2In the whole clinical trial 250
    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)
    Subjects completing the 12 month double-blind trial will be offered an open-label extension, provided there are no safety issues possibly due to blinded study drug and the subject has not experienced a renal or central nervous system flare.
    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 Decision2005-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-10-31
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