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    Summary
    EudraCT Number:2005-000443-28
    Sponsor's Protocol Code Number:IM101-033
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-09-22
    Trial results View 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2005-000443-28
    A.3Full title of the trial
    A Phase III, Multi-Center, Multi-National, Randomized, Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents with Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Study of BMS-188667 in Children and Adolescents with Juvenile Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberIM101-033
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00095173
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/64/2011
    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 supportBristol Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.com
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Juvenile Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10023267
    E.1.2Term Juvenile rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study will compare the clinical efficacy of BMS-188667 versus placebo in children and adolescents with JRA/JIA in whom a response had been initially induced by 4 months of open-label therapy. Following 6 months of double-blind treatment, clinical
    efficacy will be measured by the time to occurrence of JRA/JIA disease flare during the double-blind treatment period.
    E.2.2Secondary objectives of the trial
    1) Clinical efficacy as measured by the proportion of subjects that demonstrate JRA/JIA disease flare by Day B169.
    2) Clinical efficacy as measured by the number of active joints using the definition provided by American College of Rheumatology (ACR) Pediatric 30 (JRA/JIA core set variable).
    3) Clinical efficacy as measured by the number of joints with limited range of motion (JRA/JIA core set variable).
    4) Disease activity as measured by the Physician’s global assessment of disease severity (JRA/JIA core set variable).
    5) Assess the change in the subject’s overall well-being as measured by the Parent global assessment of overall well being (JRA/JIA core set variable).
    6) Assess the safety and tolerability of BMS-188667 in children and adolescents.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Diagnosis of JRA or JIA utilizing the standard criteria for one of the following categories:
    − JRA (ACR criteria): pauciarticular, polyarticular or systemic disease onset and polyarticular course
    − JIA (ILAR criteria): extended oligoarticular, polyarticular (RF+), polyarticular (RF-), or systemic with a polyarticular course
    2) Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by:
    − ≥ 2 active joints (i.e. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied by pain, tenderness, or both)
    − ≥ 2 joints with limitation of motion (LOM) at screening and at study Day 1 visit.
    − The same joint can separately meet the definition of an active joint and a joint with LOM
    3) Subjects must have experienced an insufficient therapeutic response or intolerance in the opinion of the examining physician to at least on DMARD.
    4) Males or females (not nursing and not pregnant) 6 – 17 years of age, inclusive at screening. Males and females of childbearing potential are eligible only if they practice effective contraceptive measures.
    E.4Principal exclusion criteria
    1) Subjects who have not previously experienced an insufficient therapeutic response or intolerance to at least one DMARD.
    2) Systemic onset JRA or systemic JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JRA/JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
    3) Active uveitis.
    4) Presence of any other rheumatic disease or major chronic
    infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.)
    5) Presence of infection at screening or history of frequent acute or chronic infections within 3 months prior to the first dose of study medication.
    6) Joint replacement surgery required during the anticipated time on study medication, including screening or history of surgery on more than 5 joints.
    7) Live vaccines within 3 months of the first dose of study medication.
    8) Active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules).
    E.5 End points
    E.5.1Primary end point(s)
    The primary evaluation of clinical response of BMS-188667 versus placebo will be the comparison of the time to occurrence of JRA/JIA disease flare during the double-blind treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy analysis will be performed on the time to occurrence of JRA/JIA disease flare, which is defined as the elapsed number of days between the first dose date in Period B and the first study day that disease flare is confirmed.
    E.5.2Secondary end point(s)
    The proportion of subjects that demonstrate JRA/JIA disease flare by Day B169 will be used for evaluating clinical response. In addition, secondary outcome measures will include the six individual core-response variables of the ACR Pediatric 30
    used to determine JRA/JIA disease flare.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary analyses include a comparison of the rate of disease flare by Day B169 between BMS-188667 and placebo.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Austria
    Brazil
    France
    Germany
    Italy
    Mexico
    Peru
    Portugal
    Spain
    Switzerland
    United States
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days8
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 63
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 127
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors aged from 6 to 17 years old.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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)
    For all subjects, after the last dose, additional 6 months post-study drug administration
    will follow.
    If subjects discontinue from the IM101033 study and continue to be treated with a compound other than abatacept, OR discontinue from the IM101033 study and continue to be treated with commercially available abatacept, these subjects will be offered the opportunity to participate in the IM101240 Registry study if abatacept has already been approved for the treatment of JIA in their country.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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