<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02971683</url>
  </required_header>
  <id_info>
    <org_study_id>IM101-611</org_study_id>
    <secondary_id>2016-002269-77</secondary_id>
    <nct_id>NCT02971683</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With&#xD;
      Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults&#xD;
      With Active Idiopathic Inflammatory Myopathy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to meet protocol objectives&#xD;
  </why_stopped>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Actual">August 2, 2022</completion_date>
  <primary_completion_date type="Actual">July 27, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue</measure>
    <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
    <description>The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24.&#xD;
The IMACS DOI is: An improvement of &gt;/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by &gt;/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by &gt;/= 25% from baseline.&#xD;
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24.</measure>
    <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
    <description>The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24</measure>
    <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
    <description>The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions.&#xD;
The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24.</measure>
    <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
    <description>The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments.&#xD;
The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24.</measure>
    <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
    <description>The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement)&#xD;
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.&#xD;
The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( &gt;/= 20 represents minimal improvement, a score of &gt;/= 40 represents moderate improvement, and a score of &gt;/= 60 represents major improvement).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period</measure>
    <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
    <description>The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period</measure>
    <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
    <description>The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period</measure>
    <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
    <description>The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period</measure>
    <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
    <description>The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Polymyositis</condition>
  <condition>Dermatomyositis</condition>
  <condition>Autoimmune Necrotizing Myopathy</condition>
  <condition>Overlap Myositis</condition>
  <condition>Juvenile Myositis Above the Age of 18</condition>
  <arm_group>
    <arm_group_label>Abatacept subcutaneous + Standard Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo of Abatacept subcutaneous + Standard Treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo of Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abatacept subcutaneous</intervention_name>
    <description>Specified dose of Abatacept subcutaneous on specified days</description>
    <arm_group_label>Abatacept subcutaneous + Standard Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo of Abatacept subcutaneous</description>
    <arm_group_label>Placebo of Abatacept subcutaneous + Standard Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Diagnosis of IIM based on the Bohan and Peter classification criteria: i) Subjects with&#xD;
        dermatomyositis (DM) must also have a confirmed myositis-associated rash (Gottron's papules&#xD;
        or a heliotrope rash preferably confirmed by skin biopsy) and 2 or more of the remaining 4&#xD;
        criteria.&#xD;
&#xD;
        ii) Subjects with a diagnosis of IIM other than DM include PM, autoimmune necrotizing&#xD;
        myopathy, myositis in association with another connective tissue disease (overlap myositis)&#xD;
        and juvenile myositis subjects above the age of 18. These subjects must have a prior muscle&#xD;
        biopsy diagnostic for IIM or a positive test for at least one myositis-specific&#xD;
        autoantibody (anti-aminoacyl-tRNA synthetases (Jo-1, PL-7, PL-12, EJ, OJ, KS, Zo, YRS),&#xD;
        anti-Mi-2, anti-SRP, anti-TIF1-g, anti-NXP-2, anti-MDA5, anti-SAE, anti-HMGCR). For&#xD;
        subjects with overlap myositis, the myositis must be the principal clinically active&#xD;
        manifestation of their disease. Where applicable, documentation of prior skin biopsy,&#xD;
        muscle biopsy, and autoantibody results must be obtained and retained by the site.&#xD;
&#xD;
          -  Demonstrable muscle weakness measured by the MMT-8 of ≤ 135 units and any 3 of the&#xD;
             following: i) MMT-8 ≤ 125 units; ii) Physician's global assessment (PGA) visual analog&#xD;
             scale (VAS) ≥2 cm; iii) Subject's global assessment (SGA) VAS ≥2 cm; iv) HAQ-DI ≥ 0.5;&#xD;
             v) One or more muscle enzyme (CK, aldolase, LDH, AST, ALT) ³ 1.3 times upper limit of&#xD;
             normal (ULN); vi) MDAAT Extramuscular Global Activity VAS ≥2 cm&#xD;
&#xD;
          -  Demonstration of currently active IIM will be determined by an adjudication committee&#xD;
             unless the subject has any one of the following: i) an active myositis-associated rash&#xD;
             (Gottron's papules or heliotrope rash), or ii) a recent (within 3 months prior to&#xD;
             signing informed consent) biopsy, magnetic resonance imaging (MRI), or electromyogram&#xD;
             (EMG) demonstrating active disease, or iii) an elevated CK &gt; 5 times the upper limit&#xD;
             of normal&#xD;
&#xD;
          -  Active disease despite prior treatment with corticosteroids, immunosuppressants, or&#xD;
             biologics as determined by the investigator&#xD;
&#xD;
          -  The subject must be on background standard treatment for IIM. The standard treatments&#xD;
             that are allowed as background treatment for IIM includes: i) Corticosteroids alone,&#xD;
             or ii) One of the following immunosuppressants: methotrexate, azathioprine,&#xD;
             mycophenolate mofetil, tacrolimus, or cyclosporine (combinations of these treatments&#xD;
             are not allowed), or iii) A combination of corticosteroids and one of the above&#xD;
             immunosuppressants. The subject must have been on the same medication(s) for IIM for&#xD;
             12 weeks prior to randomization and the dose must have been stable for 4 weeks prior&#xD;
             to randomization. If using azathioprine, the subject must have been on azathioprine&#xD;
             for at least 24 weeks with a stable dose for at least 12 weeks prior to randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with Inclusion Body Myositis (IBM), or myositis other than IIM, eg,&#xD;
             drug-induced myositis and PM associated with HIV&#xD;
&#xD;
          -  Subjects treated with penicillamine or zidovudine in the past 3 months&#xD;
&#xD;
          -  Subjects treated with rituximab in the 6 months prior to randomization (there must be&#xD;
             laboratory results indicating the presence of circulating B cells [CD19+]). Any other&#xD;
             biologic treatment in the past 3 months or immune globulin (intravenous [IVIG] or&#xD;
             subcutaneous [SCIG]) in the past 3 months prior to randomization&#xD;
&#xD;
          -  Subjects with uncontrolled or rapidly progressive interstitial lung disease&#xD;
&#xD;
          -  Subjects with severe muscle damage (Myositis Damage Index &gt; 7/10), permanent weakness&#xD;
             due to a non-IIM cause, or myositis with cardiac involvement&#xD;
&#xD;
          -  Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer&#xD;
&#xD;
          -  Subjects who are known to be positive for the anti-TIF-1 (p155/140) autoantibody prior&#xD;
             to randomization who were diagnosed with IIM &lt; 1 year prior to randomization.&#xD;
&#xD;
          -  Subjects at risk for tuberculosis&#xD;
&#xD;
          -  Subjects with recent acute infection requiring antibiotics&#xD;
&#xD;
          -  Subjects with history of chronic or recurrent bacterial, viral or systemic fungal&#xD;
             infections&#xD;
&#xD;
          -  Subjects who have a present malignancy or have had a previous malignancy within the&#xD;
             last 5 years prior to screening (except for a documented history of cured&#xD;
             non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ).&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
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    <facility>
      <name>Local Institution - 0015</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85028</zip>
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      <name>Local Institution - 0075</name>
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      <address>
        <city>Sao Paulo</city>
        <zip>04032-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0029</name>
      <address>
        <city>Praha 2</city>
        <zip>128 50</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0100</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0045</name>
      <address>
        <city>Clermont Ferrand Cedex 1</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0043</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0042</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0044</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0054</name>
      <address>
        <city>Halle (saale)</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Munchen</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0023</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
      <address>
        <city>Ferrara</city>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0024</name>
      <address>
        <city>Firenze</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0020</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0025</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0091</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>807-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0090</name>
      <address>
        <city>Sapporo-City</city>
        <state>Hokkaido</state>
        <zip>060-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0078</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0082</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaraki</state>
        <zip>3058576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0083</name>
      <address>
        <city>Kawasaki-shi</city>
        <state>Kanagawa</state>
        <zip>2168511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0084</name>
      <address>
        <city>Kumamoto-city</city>
        <state>Kumamoto</state>
        <zip>8608556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0088</name>
      <address>
        <city>Nagasaki-shi</city>
        <state>Nagasaki</state>
        <zip>8528501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sasebo city</city>
        <state>Nagasaki</state>
        <zip>857-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0077</name>
      <address>
        <city>Iruma-gun</city>
        <state>Saitama</state>
        <zip>3500495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0086</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0079</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0081</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0092</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>1608582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0093</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>1628666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0087</name>
      <address>
        <city>Ube-shi</city>
        <state>Yamaguchi</state>
        <zip>755-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0076</name>
      <address>
        <city>Miyagi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0066</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0065</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0064</name>
      <address>
        <city>Seoul</city>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0049</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0046</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>11850</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0048</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44160</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0047</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78213</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0052</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78290</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0040</name>
      <address>
        <city>Lund</city>
        <zip>22242</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0041</name>
      <address>
        <city>Orebro</city>
        <zip>70185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0037</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0038</name>
      <address>
        <city>Vasteras</city>
        <zip>72189</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Hungary</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>July 22, 2021</results_first_submitted>
  <results_first_submitted_qc>August 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2021</results_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Dermatomyositis</mesh_term>
    <mesh_term>Myositis</mesh_term>
    <mesh_term>Polymyositis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abatacept</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT02971683/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT02971683/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>148 were randomized and treated</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Double-Blind Abatacept</title>
          <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
        </group>
        <group group_id="P2">
          <title>Double-Blind Placebo</title>
          <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue study treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Double-Blind Abatacept</title>
          <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
        </group>
        <group group_id="B2">
          <title>Double-Blind Placebo</title>
          <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
            <count group_id="B2" value="73"/>
            <count group_id="B3" value="148"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.3" spread="14.41"/>
                    <measurement group_id="B2" value="48.1" spread="14.09"/>
                    <measurement group_id="B3" value="48.7" spread="14.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>16-29 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-39 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-49 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-59 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;/= 60 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue</title>
        <description>The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24.&#xD;
The IMACS DOI is: An improvement of &gt;/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by &gt;/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by &gt;/= 25% from baseline.&#xD;
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.</description>
        <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
        <population>All treated participants excluding participants with relevant protocol deviations</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue</title>
          <description>The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24.&#xD;
The IMACS DOI is: An improvement of &gt;/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by &gt;/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by &gt;/= 25% from baseline.&#xD;
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.</description>
          <population>All treated participants excluding participants with relevant protocol deviations</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" lower_limit="44.8" upper_limit="67.2"/>
                    <measurement group_id="O2" value="31" lower_limit="31.6" upper_limit="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.083</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>3.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24.</title>
        <description>The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).</description>
        <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
        <population>All treated participants with both baseline and post-baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24.</title>
          <description>The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).</description>
          <population>All treated participants with both baseline and post-baseline measurements</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.31" spread="0.067"/>
                    <measurement group_id="O2" value="-0.20" spread="0.069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24</title>
        <description>The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions.&#xD;
The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).</description>
        <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
        <population>All treated participants with both baseline and post-baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24</title>
          <description>The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions.&#xD;
The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).</description>
          <population>All treated participants with both baseline and post-baseline measurements</population>
          <units>Number of repetitions</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="1.33"/>
                    <measurement group_id="O2" value="1.2" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24.</title>
        <description>The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments.&#xD;
The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).</description>
        <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
        <population>All treated participants with both baseline and post-baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24.</title>
          <description>The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments.&#xD;
The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).</description>
          <population>All treated participants with both baseline and post-baseline measurements</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.56" spread="0.202"/>
                    <measurement group_id="O2" value="-1.40" spread="0.208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24.</title>
        <description>The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement)&#xD;
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.&#xD;
The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( &gt;/= 20 represents minimal improvement, a score of &gt;/= 40 represents moderate improvement, and a score of &gt;/= 60 represents major improvement).</description>
        <time_frame>From first dose to 24 weeks after first dose. (Approximately 169 days)</time_frame>
        <population>All treated participants with both baseline and post-baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24.</title>
          <description>The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement)&#xD;
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.&#xD;
The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( &gt;/= 20 represents minimal improvement, a score of &gt;/= 40 represents moderate improvement, and a score of &gt;/= 60 represents major improvement).</description>
          <population>All treated participants with both baseline and post-baseline measurements</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.83" spread="2.873"/>
                    <measurement group_id="O2" value="37.22" spread="2.963"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period</title>
        <description>The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.</description>
        <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period</title>
          <description>The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period</title>
        <description>The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
        <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period</title>
          <description>The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period</title>
        <description>The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.</description>
        <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period</title>
          <description>The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malignancies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autoimmune Disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systemic Injection Reactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Injection Site Reactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period</title>
        <description>The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.</description>
        <time_frame>From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind Abatacept</title>
            <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind Placebo</title>
            <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period</title>
          <description>The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>LOW LEUKOCYTES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH LEUKOCYTES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH EOSINOPHILS (ABSOLUTE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LOW LYMPHOCYTES (ABSOLUTE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LOW NEUTROPHILS + BANDS (ABSOLUTE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH ALANINE AMINOTRANSFERASE (ALT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH ASPARTATE AMINOTRANSFERASE (AST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH G-GLUTAMYL TRANSFERASE (GGT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH BLOOD UREA NITROGEN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH CREATININE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH CALCIUM, TOTAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LOW PHOSPHORUS, INORGANIC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH PHOSPHORUS, INORGANIC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH SODIUM, SERUM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LOW GLUCOSE, SERUM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH GLUCOSE, SERUM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH PROTEIN, TOTAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH CREATINE KINASE (CK)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIGH LACTATE DEHYDROGENASE (LD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose to 100 days post last dose (up to 3 years, 8 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DOUBLE-BLIND ABATACEPT</title>
          <description>Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)</description>
        </group>
        <group group_id="E2">
          <title>DOUBLE-BLIND PLACEBO</title>
          <description>Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Polymyositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please email</phone>
      <email>Clinical.Trials@bms.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02971683
org study id: IM101-611
secondary id: 2016-002269-77
nct id: NCT02971683
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With
      Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults
      With Active Idiopathic Inflammatory Myopathy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
description: The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24.
The IMACS DOI is: An improvement of >/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by >/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by >/= 25% from baseline.
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.
measure: Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24.
time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
description: The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).
measure: Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24
time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
description: The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions.
The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).
measure: Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24.
time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
description: The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments.
The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).
measure: Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24.
time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
description: The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement)
IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.
The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( >/= 20 represents minimal improvement, a score of >/= 40 represents moderate improvement, and a score of >/= 60 represents major improvement).
measure: Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period
time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.
description: The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.
measure: Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period
time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.
description: The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
measure: Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period
time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.
description: The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
measure: Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period
time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.
description: The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.
arm group label: Abatacept subcutaneous + Standard Treatment
arm group type: Active Comparator
description: Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
arm group label: Placebo of Abatacept subcutaneous + Standard Treatment
arm group type: Placebo Comparator
description: Placebo of Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
intervention type: Drug
intervention name: Abatacept subcutaneous
description: Specified dose of Abatacept subcutaneous on specified days
arm group label: Abatacept subcutaneous + Standard Treatment
intervention type: Drug
intervention name: Placebo
description: Placebo of Abatacept subcutaneous
arm group label: Placebo of Abatacept subcutaneous + Standard Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Australia
country: Brazil
country: Czechia
country: France
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Sweden
country: United States
country: Hungary
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Muscular Diseases
mesh term: Dermatomyositis
mesh term: Myositis
mesh term: Polymyositis
mesh term: Abatacept
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 