<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/NCT03257852</url>
  </required_header>
  <id_info>
    <org_study_id>5094-CL-0201</org_study_id>
    <nct_id>NCT03257852</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate</brief_title>
  <official_title>A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of&#xD;
      ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate&#xD;
      (MTX).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study drug will be intravenously administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">October 16, 2018</completion_date>
  <primary_completion_date type="Actual">September 19, 2018</primary_completion_date>
  <phase>Phase 2</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>ACR50 response rate</measure>
    <time_frame>Week 12</time_frame>
    <description>To assess ACR (American College of Rheumatology) 50 for efficacy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ACR50 response rate</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess ACR (American College of Rheumatology) 50 for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR20 response rate</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess ACR (American College of Rheumatology) 20 for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR70 response rate</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess ACR (American College of Rheumatology) 70 for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in DAS28-CRP score</measure>
    <time_frame>Baseline and Up to Week 16</time_frame>
    <description>To assess DAS28-CRP (Disease Activity Score28 - C-reactive protein) for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in DAS28-ESR score</measure>
    <time_frame>Baseline and Up to Week 16</time_frame>
    <description>To assess DAS28-ESR (Disease Activity Score28 - Erythrocyte sedimentation rate) for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Tender Joint Count (68 joints)</measure>
    <time_frame>Baseline and Up to Week 16</time_frame>
    <description>To assess Tender Joint Count for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Swollen Joint Count (66 joints)</measure>
    <time_frame>Baseline and Up to Week 16</time_frame>
    <description>To assess Swollen Joint Count for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving DAS28-CRP score for remission (&lt;2.6)</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess DAS28-CRP score for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving DAS28-ESR score for remission (&lt;2.6)</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess DAS28-ESR score for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving DAS28-CRP score for low disease activity (≦3.2)</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess DAS28-CRP score for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving DAS28-ESR score for low disease activity (≦3.2)</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess DAS28-ESR score for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in CRP</measure>
    <time_frame>Baseline and Up to Week 16</time_frame>
    <description>To assess CRP (C-reactive protein) for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ESR</measure>
    <time_frame>Baseline and Up to Week 16</time_frame>
    <description>To assess ESR (Erythrocyte sedimentation rate) for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving EULAR response criteria of &quot;Good Response&quot;</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess EULAR (European league Against Rheumatism) response criteria for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving EULAR response criteria of &quot;Good Response&quot; or &quot;Moderate Response&quot;</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess EULAR response criteria for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving ACR/EULAR score for remission</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess ACR/EULAR remission for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess SDAI (Simplified Disease Activity Index) score for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving CDAI score ≦ 2.8 (CDAI remission)</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess CDAI (Clinical Disease Activity Index) score for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for the HAQ-DI</measure>
    <time_frame>Baseline to Up to Week 16</time_frame>
    <description>To assess HAQ-DI (Health Assessment Questionnaire - Disability Index) for efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by incidence of adverse events</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by laboratory tests: Hematology</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess hematology as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by laboratory tests: Biochemistry</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess Biochemistry as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by laboratory tests: Urinalysis</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess Urinalysis as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by vital signs: Body temperature</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess the vital sign as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by vital signs: Sitting blood pressure</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess the vital sign as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by vital signs: pulse rate</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess the vital sign as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by weight</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess the weight as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by standard 12-lead electrocardiogram</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess the cardiovascular system functioning as a criteria of safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentration of ASP5094</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess Serum concentration of ASP5094 for pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentration of TNF-α</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess TNF-α (Tumor Necrosis Factor-α) for pharmacodynamics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentration of MMP3</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentration of IL-6</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess IL-6 (Interleukin-6) for pharmacodynamics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-ASP5094 anti-bodies</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>To assess Anti-ASP5094 anti-bodies for immunogenicity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Rheumatoid Arthritis (RA)</condition>
  <arm_group>
    <arm_group_label>ASP5094 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP5094</intervention_name>
    <description>intravenously administration</description>
    <arm_group_label>ASP5094 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>intravenously administration</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Methotrexate therapy</intervention_name>
    <description>MTX must have been continuously orally administered for at least 90 days prior to screening, with stable dosage for at least 28 days prior to screening, and will be continuously administered with the same dosage throughout the study period.</description>
    <arm_group_label>ASP5094 Group</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR)&#xD;
             criteria or the 2010 ACR/European League Against Rheumatism (EULAR) criteria at least&#xD;
             6 months prior to screening.&#xD;
&#xD;
          -  Subject meets the 1991 ACR Revised Criteria for the Classification of Global&#xD;
             Functional Status in RA Class I, II, or III at screening.&#xD;
&#xD;
          -  At screening and baseline, subject has active RA as evidenced by both of the&#xD;
             following:&#xD;
&#xD;
               -  ≥ 6 tender/painful joints (using 68-joint assessment)&#xD;
&#xD;
               -  ≥ 6 swollen joints (using 66-joint assessment)&#xD;
&#xD;
          -  Subject meets the criterion for a CRP level (Latex Agglutination method) at screening.&#xD;
&#xD;
          -  Subject who has continuously received Methotrexate for at least 90 days prior to&#xD;
             screening and who is able to continue a stable dose of Methotrexate from at least 28&#xD;
             days prior to screening throughout the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has deviated from the criteria for previous and concomitant treatment before&#xD;
             baseline.&#xD;
&#xD;
          -  Subject has an ongoing infection requiring antibiotics.&#xD;
&#xD;
          -  Subject is determined to be an inadequate responder to a prior biologic disease&#xD;
             modifying antirheumatic drugs (DMARDs) or Janus kinase (JAK) inhibitors.&#xD;
&#xD;
          -  Subject has participated in previous ASP5094 clinical trial.&#xD;
&#xD;
          -  Subject has participated in a clinical trial or post-marketing clinical study of&#xD;
             another ethical drug or medical device within 12 weeks (84 days).&#xD;
&#xD;
          -  Subject has another inflammatory arthritis than RA, or any other articular symptom&#xD;
             which may affect on joint assessment.&#xD;
&#xD;
          -  Subject meets any of the criteria for laboratory values at screening.&#xD;
&#xD;
          -  Subject has a positive T-SPOT or QuantiFERON Gold test within 90 days prior to&#xD;
             screening or at screening.&#xD;
&#xD;
          -  Subject has a history of or concurrent malignant tumor.&#xD;
&#xD;
          -  Subject has autoimmune disease except for RA or any severe, progressive, or&#xD;
             uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine,&#xD;
             pulmonary, cardiac, neurological, or mental illness.&#xD;
&#xD;
          -  Subject has a history of clinically significant allergy.&#xD;
&#xD;
          -  Subject has clinically significant abnormalities on 12-lead electrocardiogram (ECG) at&#xD;
             screening.&#xD;
&#xD;
          -  Subject has a history of Human Immunodeficiency Virus (HIV) infection.&#xD;
&#xD;
          -  Subject had surgery within 30 days prior to screening or has a planned elective&#xD;
             surgery.&#xD;
&#xD;
          -  Subject has a wound that is currently healing at baseline.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site JP00002</name>
      <address>
        <city>Asahikawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00027</name>
      <address>
        <city>Asahikawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00029</name>
      <address>
        <city>Beppu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00015</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00008</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00009</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00026</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00016</name>
      <address>
        <city>Ichinomiya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00012</name>
      <address>
        <city>Kanuma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00028</name>
      <address>
        <city>Kawachinagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00005</name>
      <address>
        <city>Kitamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00025</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00030</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00010</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00006</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00018</name>
      <address>
        <city>Meguro</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00020</name>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00014</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00011</name>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00022</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00003</name>
      <address>
        <city>Osaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00019</name>
      <address>
        <city>Sagamihara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00007</name>
      <address>
        <city>Sanuki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00001</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00023</name>
      <address>
        <city>Shimonoseki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00021</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00004</name>
      <address>
        <city>Takasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00017</name>
      <address>
        <city>Tomakomai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00013</name>
      <address>
        <city>Toyohashi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00024</name>
      <address>
        <city>Tsukuba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00031</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/study.aspx?ID=348</url>
    <description>Link to results on the Astellas Clinical Study Results website</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 31, 2019</last_update_submitted>
  <last_update_submitted_qc>October 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Methotrexate</keyword>
  <keyword>Arthritis, Rheumatoid</keyword>
  <keyword>ASP5094</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrexate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.</ipd_time_frame>
    <ipd_access_criteria>Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03257852
org study id: 5094-CL-0201
nct id: NCT03257852
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of
      ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate
      (MTX).
The study drug will be intravenously administered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ACR50 response rate
time frame: Week 12
description: To assess ACR (American College of Rheumatology) 50 for efficacy
measure: ACR50 response rate
time frame: Up to Week 16
description: To assess ACR (American College of Rheumatology) 50 for efficacy
measure: ACR20 response rate
time frame: Up to Week 16
description: To assess ACR (American College of Rheumatology) 20 for efficacy
measure: ACR70 response rate
time frame: Up to Week 16
description: To assess ACR (American College of Rheumatology) 70 for efficacy
measure: Change from baseline in DAS28-CRP score
time frame: Baseline and Up to Week 16
description: To assess DAS28-CRP (Disease Activity Score28 - C-reactive protein) for efficacy
measure: Change from baseline in DAS28-ESR score
time frame: Baseline and Up to Week 16
description: To assess DAS28-ESR (Disease Activity Score28 - Erythrocyte sedimentation rate) for efficacy
measure: Change from baseline in Tender Joint Count (68 joints)
time frame: Baseline and Up to Week 16
description: To assess Tender Joint Count for efficacy
measure: Change from baseline in Swollen Joint Count (66 joints)
time frame: Baseline and Up to Week 16
description: To assess Swollen Joint Count for efficacy
measure: Percentage of subjects achieving DAS28-CRP score for remission (<2.6)
time frame: Up to Week 16
description: To assess DAS28-CRP score for efficacy
measure: Percentage of subjects achieving DAS28-ESR score for remission (<2.6)
time frame: Up to Week 16
description: To assess DAS28-ESR score for efficacy
measure: Percentage of subjects achieving DAS28-CRP score for low disease activity (≦3.2)
time frame: Up to Week 16
description: To assess DAS28-CRP score for efficacy
measure: Percentage of subjects achieving DAS28-ESR score for low disease activity (≦3.2)
time frame: Up to Week 16
description: To assess DAS28-ESR score for efficacy
measure: Change from baseline in CRP
time frame: Baseline and Up to Week 16
description: To assess CRP (C-reactive protein) for efficacy
measure: Change from baseline in ESR
time frame: Baseline and Up to Week 16
description: To assess ESR (Erythrocyte sedimentation rate) for efficacy
measure: Percentage of subjects achieving EULAR response criteria of "Good Response"
time frame: Up to Week 16
description: To assess EULAR (European league Against Rheumatism) response criteria for efficacy
measure: Percentage of subjects achieving EULAR response criteria of "Good Response" or "Moderate Response"
time frame: Up to Week 16
description: To assess EULAR response criteria for efficacy
measure: Percentage of subjects achieving ACR/EULAR score for remission
time frame: Up to Week 16
description: To assess ACR/EULAR remission for efficacy
measure: Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)
time frame: Up to Week 16
description: To assess SDAI (Simplified Disease Activity Index) score for efficacy
measure: Percentage of subjects achieving CDAI score ≦ 2.8 (CDAI remission)
time frame: Up to Week 16
description: To assess CDAI (Clinical Disease Activity Index) score for efficacy
measure: Change from baseline for the HAQ-DI
time frame: Baseline to Up to Week 16
description: To assess HAQ-DI (Health Assessment Questionnaire - Disability Index) for efficacy
measure: Safety assessed by incidence of adverse events
time frame: Up to Week 16
description: Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
measure: Safety assessed by laboratory tests: Hematology
time frame: Up to Week 16
description: To assess hematology as a criteria of safety variables.
measure: Safety assessed by laboratory tests: Biochemistry
time frame: Up to Week 16
description: To assess Biochemistry as a criteria of safety variables.
measure: Safety assessed by laboratory tests: Urinalysis
time frame: Up to Week 16
description: To assess Urinalysis as a criteria of safety variables.
measure: Safety assessed by vital signs: Body temperature
time frame: Up to Week 16
description: To assess the vital sign as a criteria of safety variables.
measure: Safety assessed by vital signs: Sitting blood pressure
time frame: Up to Week 16
description: To assess the vital sign as a criteria of safety variables.
measure: Safety assessed by vital signs: pulse rate
time frame: Up to Week 16
description: To assess the vital sign as a criteria of safety variables.
measure: Safety assessed by weight
time frame: Up to Week 16
description: To assess the weight as a criteria of safety variables.
measure: Safety assessed by standard 12-lead electrocardiogram
time frame: Up to Week 16
description: To assess the cardiovascular system functioning as a criteria of safety variables.
measure: Serum concentration of ASP5094
time frame: Up to Week 16
description: To assess Serum concentration of ASP5094 for pharmacokinetics
measure: Serum concentration of TNF-α
time frame: Up to Week 16
description: To assess TNF-α (Tumor Necrosis Factor-α) for pharmacodynamics
measure: Serum concentration of MMP3
time frame: Up to Week 16
description: To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics
measure: Serum concentration of IL-6
time frame: Up to Week 16
description: To assess IL-6 (Interleukin-6) for pharmacodynamics
measure: Anti-ASP5094 anti-bodies
time frame: Up to Week 16
description: To assess Anti-ASP5094 anti-bodies for immunogenicity
arm group label: ASP5094 Group
arm group type: Experimental
description: To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
intervention type: Drug
intervention name: ASP5094
description: intravenously administration
arm group label: ASP5094 Group
intervention type: Drug
intervention name: Placebo
description: intravenously administration
arm group label: Placebo Group
intervention type: Other
intervention name: Methotrexate therapy
description: MTX must have been continuously orally administered for at least 90 days prior to screening, with stable dosage for at least 28 days prior to screening, and will be continuously administered with the same dosage throughout the study period.
arm group label: ASP5094 Group
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
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country: Japan
url: https://astellasclinicalstudyresults.com/study.aspx?ID=348
description: Link to results on the Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Methotrexate
sharing ipd: Yes
ipd description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
ipd access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
ipd url: https://www.clinicalstudydatarequest.com/