<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/NCT01711814</url>
  </required_header>
  <id_info>
    <org_study_id>015K-CL-RA25</org_study_id>
    <secondary_id>2011-006021-23</secondary_id>
    <nct_id>NCT01711814</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study</brief_title>
  <official_title>A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Biotech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in&#xD;
      subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is comprised of a 104 week treatment period beginning on Day 1 of study drug&#xD;
      administration and a 30-day follow-up period or permanent termination of clinical development&#xD;
      of the product, whichever is earlier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2012</start_date>
  <completion_date type="Actual">March 25, 2016</completion_date>
  <primary_completion_date type="Actual">March 25, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety assessed by recording of adverse events and clinical laboratory evaluations</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">611</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>ASP015K</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>peficitinib</intervention_name>
    <description>oral</description>
    <arm_group_label>ASP015K</arm_group_label>
    <other_name>ASP015K</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject completed the week 12 visit in one of the Phase 2, ASP015K Rheumatoid&#xD;
             Arthritis studies within the previous 14 days.&#xD;
&#xD;
          -  Male and Female subjects must be willing to comply with contraception requirements as&#xD;
             well as restrictions regarding egg and sperm donation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has any condition considered by the Principal Investigator or Medical Monitor&#xD;
             to preclude adequate evaluation of drug safety&#xD;
&#xD;
          -  Subject is scheduled to receive any investigational drug other than ASP015K during the&#xD;
             course of the study&#xD;
&#xD;
          -  Subject is scheduled to receive a prohibited medication&#xD;
&#xD;
          -  Subject has a planned major surgery&#xD;
&#xD;
          -  Subject discontinued study drug due to meeting study drug discontinuation criteria&#xD;
             prior to completion of the Week 12 visit in the preceding study or fulfills study drug&#xD;
             discontinuation criteria at the final study visit of the preceding study&#xD;
&#xD;
          -  Subject has out of range laboratory values within 14 days of the Day 1 study dosing&#xD;
&#xD;
          -  Absolute lymphocyte count (ALC) &lt; 500/mm3&#xD;
&#xD;
          -  Creatine Phosphokinase (CPK) &gt; 1.5 x upper limit of normal unless the level has been&#xD;
             stable for at least 2 consecutive blood draws (at least 7 days apart), and subject&#xD;
             does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps&#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>Senior Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site US3218</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US828</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0943</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3227</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US219</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3332</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3331</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US1894</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3232</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US702</name>
      <address>
        <city>Morton Grove</city>
        <state>Illinois</state>
        <zip>60053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3226</name>
      <address>
        <city>Vernon Hills</city>
        <state>Illinois</state>
        <zip>60061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3329</name>
      <address>
        <city>Elizabethtown</city>
        <state>Kentucky</state>
        <zip>42701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US291</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3298</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3300</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US345</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3304</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3306</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3319</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3327</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3320</name>
      <address>
        <city>Clarksburg</city>
        <state>West Virginia</state>
        <zip>26301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE3387</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE3314</name>
      <address>
        <city>Brussels</city>
        <zip>1190</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BG3613</name>
      <address>
        <city>Burgas</city>
        <zip>8000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BG3217</name>
      <address>
        <city>Plovdiv</city>
        <zip>4003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BG3303</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CO3326</name>
      <address>
        <city>Barranquilla, Atlantico</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CO3297</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CO2826</name>
      <address>
        <city>Bucamaranga</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CO3450</name>
      <address>
        <city>Bucaramanga</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CO3451</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CZ3388</name>
      <address>
        <city>Praha 2</city>
        <zip>128 50</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CZ3376</name>
      <address>
        <city>Praha-Nusle</city>
        <zip>140 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CZ3225</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>68601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CZ3449</name>
      <address>
        <city>Zlin</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU3461</name>
      <address>
        <city>Balatonfüred</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU3398</name>
      <address>
        <city>Bekescsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU3302</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU3448</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU3462</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site HU3447</name>
      <address>
        <city>Debrecen</city>
        <zip>H-4043</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site MX3307</name>
      <address>
        <city>Guadalajara, Jalisco</city>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site MX3238</name>
      <address>
        <city>Guadalajara</city>
        <zip>44650</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site MX3310</name>
      <address>
        <city>Mexico</city>
        <zip>6700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site MX3317</name>
      <address>
        <city>Morelia</city>
        <zip>58070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL3233</name>
      <address>
        <city>Bialystok</city>
        <state>Polska</state>
        <zip>15-351</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL3391</name>
      <address>
        <city>Bialystok</city>
        <zip>15-879</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL2893</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL3603</name>
      <address>
        <city>Krakow</city>
        <zip>31-637</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL3601</name>
      <address>
        <city>Lublin</city>
        <zip>20-582</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL3600</name>
      <address>
        <city>Warszawa</city>
        <zip>02-118</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site PL3599</name>
      <address>
        <city>Warszawa</city>
        <zip>02-653</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Hungary</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/study.aspx?ID=324</url>
    <description>Link to results on the Astellas Clinical Study Results website</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>ASP015K</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>Peficitinib</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/NCT01711814
org study id: 015K-CL-RA25
secondary id: 2011-006021-23
nct id: NCT01711814
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in
      subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA
      study.
This study is comprised of a 104 week treatment period beginning on Day 1 of study drug
      administration and a 30-day follow-up period or permanent termination of clinical development
      of the product, whichever is earlier.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety assessed by recording of adverse events and clinical laboratory evaluations
time frame: 2 years
arm group label: ASP015K
arm group type: Experimental
description: Experimental
intervention type: Drug
intervention name: peficitinib
description: oral
arm group label: ASP015K
other name: ASP015K
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Senior Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development
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country: Belgium
country: Bulgaria
country: Colombia
country: Czechia
country: Hungary
country: Mexico
country: Poland
country: United States
country: Czech Republic
url: https://astellasclinicalstudyresults.com/study.aspx?ID=324
description: Link to results on the Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Peficitinib
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/