<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/NCT01683695</url>
  </required_header>
  <id_info>
    <org_study_id>20101103</org_study_id>
    <nct_id>NCT01683695</nct_id>
  </id_info>
  <brief_title>Safety Study of AMG 557 in Subjects With Lupus Arthritis</brief_title>
  <official_title>A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose&#xD;
      study that will enroll approximately 40 systemic lupus erythematosus subjects with active&#xD;
      lupus arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 1</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>Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.</measure>
    <time_frame>330 days, including a 21-day screening period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lupus Arthritis Response Rate</measure>
    <time_frame>Day 169</time_frame>
    <description>Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.</measure>
    <time_frame>Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.</measure>
    <time_frame>Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline.</measure>
    <time_frame>Days 85-169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving reduction in and maintenance of prednisone (or its</measure>
    <time_frame>Days 85-169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Assessment of Disease Activity (PGADA).</measure>
    <time_frame>330 days, including a 21-day screening period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Global Assessment of Disease Activity (SGADA).</measure>
    <time_frame>330 days, including a 21-day screening period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum PK profile of AMG 557 after multiple dose administrations.</measure>
    <time_frame>330 days, including a 21-day screening period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.</measure>
    <time_frame>Day 85 to Day 169</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Lupus Arthritis, Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>AMG 557</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AMG 557 Matching Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 557</intervention_name>
    <description>AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.</description>
    <arm_group_label>AMG 557</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <description>Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.</description>
    <arm_group_label>AMG 557 Matching Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of SLE for at least 6 months as defined by the most recent American College&#xD;
             of Rheumatology criteria&#xD;
&#xD;
          -  Presence of lupus related inflammatory arthritis with at least four tender and four&#xD;
             swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6&#xD;
             at screening;&#xD;
&#xD;
          -  Other inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence or history of vasculitis, and presence or history of active lupus nephritis&#xD;
             requiring therapy within the last 3 years&#xD;
&#xD;
          -  Any disorder (including psychiatric), condition, clinically significant disease,&#xD;
             disease activity related to SLE&#xD;
&#xD;
          -  Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C&#xD;
             antibodies&#xD;
&#xD;
          -  Known residential exposure to an individual with tuberculosis or positive Quantiferon&#xD;
             test or PPD test at screening&#xD;
&#xD;
          -  Men and women of reproductive potential, unwilling to practice a highly effective&#xD;
             method of birth control for the duration of the study&#xD;
&#xD;
          -  Other exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94578</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lille cedex 01</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan</state>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B18 7QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>WC1E 6JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Malaysia</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Singapore</country>
  </removed_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>March 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01683695
org study id: 20101103
nct id: NCT01683695
lead sponsor: 
has dmc: No
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose
      study that will enroll approximately 40 systemic lupus erythematosus subjects with active
      lupus arthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
time frame: 330 days, including a 21-day screening period
measure: Lupus Arthritis Response Rate
time frame: Day 169
description: Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline
measure: Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.
time frame: Day 169
measure: Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.
time frame: Day 169
measure: Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline.
time frame: Days 85-169
measure: Proportion of subjects achieving reduction in and maintenance of prednisone (or its
time frame: Days 85-169
measure: Physician Global Assessment of Disease Activity (PGADA).
time frame: 330 days, including a 21-day screening period
measure: Subject Global Assessment of Disease Activity (SGADA).
time frame: 330 days, including a 21-day screening period
measure: Serum PK profile of AMG 557 after multiple dose administrations.
time frame: 330 days, including a 21-day screening period
measure: Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects
time frame: Day 29
measure: Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.
time frame: Day 85 to Day 169
arm group label: AMG 557
arm group type: Active Comparator
description: All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
arm group label: AMG 557 Matching Placebo
arm group type: Placebo Comparator
description: All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
intervention type: Drug
intervention name: AMG 557
description: AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
arm group label: AMG 557
intervention type: Drug
intervention name: Matching Placebo
description: Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
arm group label: AMG 557 Matching Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Denmark
country: France
country: Germany
country: Malaysia
country: Taiwan
country: United Kingdom
country: United States
country: Singapore
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Lupus Erythematosus, Systemic