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    Summary
    EudraCT Number:2005-004575-37
    Sponsor's Protocol Code Number:IM101075
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-15
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-004575-37
    A.3Full title of the trial
    A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).

    Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).
    A.4.1Sponsor's protocol code numberIM101075
    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 Company
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 CellCept
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 namemycophenolate mofetil
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmycophenolate mofetil
    D.3.9.1CAS number 24280-93-1
    D.3.9.2Current sponsor codeMMF
    D.3.9.3Other descriptive nameCellCept
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    IMMUNOSUPPRESSION FOR DISEASE, NOS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    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 (DB) Period:
    The primary objective of this study is to compare the time to achieving confirmed
    protocol-defined complete renal response of lupus glomerulonephritis (defined in
    Section 3.3.1.1) during this 12 month double-blind study of two abatacept regimens
    versus placebo on a background of MMF plus glucocorticosteroids using the classical
    Cox proportional hazards model.

    *Open-Label (OL) Extension Phase:
    Assess the long-term clinical safety and tolerability of abatacept treatment during the
    Open-Label Extension Phase.
    E.2.2Secondary objectives of the trial
    *DB:
    1) Compare the proportion of subjects achieving confirmed complete renal response of
    lupus glomerulonephritis at 12 months between the abatacept and placebo regimens.
    2) Assess the time to achieving Renal Improvement (Section 3.3.1.2); or together the
    criteria Complete Renal Response (Section 3.3.1.1) and Renal Improvement (Section
    3.3.1.2) between the abatacept and placebo regimens.
    3) Assess the proportion of subjects achieving Renal Improvement (Section 3.3.1.2) or
    together the criteria Complete Renal Response (Section 3.3.1.1) and Renal
    Improvement (Section 3.3.1.2) between the abatacept and placebo regimens.
    Refer to protocol section 2.2 for additional DB phase Sec. Objectives

    *OL:
    Assess durability of efficacy (e.g. complete renal response, renal improvement,
    SLICC/ACR Damage Index), immunogenicity, and corticosteroid use.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed written informed consent
    2) SLE as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus (Protocol Appendix 1), either sequentially or coincidentally. The 4 criteria need not be present at the time of study entry.
    3) Biopsy within 12 months prior to screening visit indicating active proliferative lupus
    glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III
    (C), IV-S (C) and IV-G (C)] or WHO 1982 Classification Class III or IV (excluding
    Class III c, IVd). NOTE: If the biopsy was performed > 3 months but ≤ 12 months
    prior to screening visit, at least 1 of the following 3 serologies (performed locally)
    must be abnormal prior to screening visit:
    Complement (C3 or C4) level below normal range
    OR
    Anti-dsDNA > upper limit of normal range
    4) Active renal disease at the screening visit, as defined by:
    urinary protein/creatinine ratio ≥ 50 mg/mmol AND an active urinary sediment as defined by at least one of the following 3 criteria:
    a) > 5 RBC/hpf OR
    b) > 8 WBC/hpf (with no evidence of a urinary tract infection) OR
    c) cylindruria
    Subjects not meeting all the criteria but meeting all other inclusion and exclusion
    criteria may be re-screened for urinary sediment ONCE within 2 weeks of the original
    screening visit in consultation with the BMS Medical Monitor.
    NOTE: Subjects prior to consenting who were treated with systemic
    glucocorticosteroid treatment (at least 30 mg or 0.5 mg/kg of prednisone-equivalent
    or intravenous pulse, as per local standards) during the current episode of lupus
    nephritis AND had documented abnormal (> ULN) urinary sediment (as per local
    laboratory) during the current episode of lupus nephritis AND have persisting
    proteinuria (urinary protein/creatinine ratio ≥ 50 mg/mmol) present at screening visit,
    will be considered to have met this inclusion criterion.
    5) Serum creatinine ≤ 3 mg/dL (i.e., ≤ 265 micromol/L). (Subjects not meeting this criterion but meeting all other inclusion and exclusion criteria may be re-screened for serum creatinine ONCE
    within 2 weeks of the original screening visit in consultation with the BMS Medical
    Monitor).
    6) Men and women, at least 16 years of age.
    7) Eligibility of subjects for entry into the study is based on their current renal disease activity which may represent:
    a) The first manifestation of their SLE.
    b) The first renal manifestation of SLE.
    c) Recent worsening of glomerulonephritis that had been diagnosed previously.
    d) Persistence of renal disease despite current therapies, including MMF and/or
    glucocorticosteroids, as long as the medications used are permitted by protocol.
    E.4Principal exclusion criteria
    1)WOCBP unwilling or unable to use an acceptable method to avoid pregnancy for entire study period & up to 10 weeks after study
    2)WOCBP using a prohibited contraceptive method (there are none)
    3)pregnant or breastfeeding women
    4)Women with positive pregnancy test on enrollment or prior to study drug
    administration
    5)Males unwilling or unable to follow recommendations for use of contraception
    specified by the manufacturer of any protocol-permitted disease sparing medication
    (biologic or non-biologic) being used during study
    6)Subjects with a rise of serum creatinine of ≥ 1 mg/dL within 1 month prior to screening visit
    7)Subjects with drug-induced SLE, as opposed to idiopathic SLE.
    8)Subjects with severe, unstable &/or progressive CNS lupus (screening MRI or other imaging of the brain is not required to rule-out CNS disease in subjects who have no clinical features suggesting active CNS disease)
    9)Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; RA, MS)
    10)Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,
    hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological,
    endocrine, 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
    11)Concomitant illness that in the opinion of the investigator, is likely to require
    additional high dose oral glucocorticosteroid therapy (i.e. > 45 mg per day) during study, (e.g.; asthma)
    12)Female subjects who have had breast cancer screening study suspicious for malignancy, & in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
    13) Female subjects who have evidence of cervical dysplasia that require definitive
    therapy according to local guidelines or the Consensus Guidelines and have not been
    properly treated (refer to Protocol Section 7.3.2.4).
    14) 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 mst be removed prior to randomization (Day 1 treatment). Subjects with carcinoma n situ, treated with definitive surgical intervention, are allowed.
    15) Subjects with any serious bacterial infection within the last 3 months, unless treated nd resolved with antibiotics, or any chronic bacterial infection (such as chronic
    pyelonephritis, osteomyelitis and bronchiectasis).
    16) Subjects at risk for tuberculosis. Specifically, subjects with:
    a) Current clinical, radiographic or laboratory evidence of active TB.
    b) A history of active TB within the last 3 years even if it was treated.
    c) A history of active TB greater than 3 years ago unless there is documentation that
    the prior anti-TB treatment was appropriate in duration and type.
    d) Latent TB which has not been successfully treated.
    17) Subjects with herpes zoster that resolved less than 2 months prior to screening visit.
    18) 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.
    19) Subjects who are renal transplant recipients or candidates.
    20) Subjects who are diagnosed as end-stage renal disease.
    21) Subjects with persistent non-lupus related pyuria.
    22) Subjects with a degree of tubulo-interstitial changes that suggest an irreversible
    decrease in renal function.
    23) Subjects currently on hydroxychloroquine or chloroquine with evidence of
    retinopathy within 6 months of screening visit. If local standards for routine
    ophthalmologic follow-up suggest such formal examinations are needed subjects who have had no ophthalmologic evaluation and will not have this examination done will be excluded.
    24) Hepatitis-B surface antigen-positive subjects.
    25) Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR-positive.
    26) Subjects with serum ALT or AST > 3 times upper limit of normal UNLESS IN THE
    JUDGMENT OF THE INVESTIGATOR THE ELEVATION IS EXPLICITLY RELATED TO SLE.
    27) Any other laboratory test results that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.
    28) Subjects who have at any time in the past received treatment with CTLA4Ig or
    abatacept.
    29) Subjects taking anti-proteinuric agents (e.g. angiotensin II receptor blockers, ACE inhibitors) for less than 1 month prior to randomization [Day 1]).

    Refer to Protocol Section 5.2 for additional Exclusion Criteria.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to complete renal response as defined
    by this protocol. The proportion of subjects experiencing a complete renal response or renal improvement during the 12 months will be secondary endpoints.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health related Quality of Life: The Short Form-36 Questionnaire
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open Label extension after double blind study period
    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 EEA13
    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
    LPLV
    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 Yes
    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) Yes
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 460
    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 Decision2007-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-22
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