<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/NCT03757065</url>
  </required_header>
  <id_info>
    <org_study_id>ALPN000-001</org_study_id>
    <nct_id>NCT03757065</nct_id>
  </id_info>
  <brief_title>Cell Surface Marker Expression in Autoimmune Diseases</brief_title>
  <acronym>CASCADE</acronym>
  <official_title>A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alpine Immune Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alpine Immune Sciences, 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>
      This study is designed to explore the expression of cell-surface markers in the following&#xD;
      seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple&#xD;
      sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g)&#xD;
      inflammatory myositis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2019</start_date>
  <completion_date type="Actual">October 25, 2019</completion_date>
  <primary_completion_date type="Actual">October 25, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CD28 Expression</measure>
    <time_frame>At enrollment</time_frame>
    <description>Percentage of CD28+ T cells in peripheral blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICOS Expression</measure>
    <time_frame>At enrollment</time_frame>
    <description>Percentage of ICOS+ T cells in peripheral blood</description>
  </primary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Sjogren's Syndrome</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Systemic Sclerosis</condition>
  <condition>Crohn's Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Inflammatory Myositis</condition>
  <arm_group>
    <arm_group_label>Systemic Lupus Erythematosus</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Sjogren's Syndrome</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Systemic Sclerosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Crohn's Disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Ulcerative Colitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Inflammatory Myositis</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, multiple&#xD;
        sclerosis, Crohn's disease, ulcerative colitis, or inflammatory myositis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participants 19 years of age or older.&#xD;
&#xD;
          2. Participant or legal surrogate able and willing to provide written, informed consent.&#xD;
&#xD;
          3. Participant is, or has been undergoing care for one of the specified diseases in a&#xD;
             participating centre with a confirmed clinical diagnosis of the specified disease.&#xD;
&#xD;
          4. Participant has or will provide the relevant peripheral blood (required) and normal&#xD;
             practice tissue specimens (if available).&#xD;
&#xD;
          5. Participant has one of the following target auto-immune or inflammatory diseases&#xD;
             diagnosed according to local clinical practice guidelines:&#xD;
&#xD;
               1. Crohn's Disease&#xD;
&#xD;
               2. Inflammatory myositis&#xD;
&#xD;
               3. Multiple sclerosis&#xD;
&#xD;
               4. Sjogren's syndrome&#xD;
&#xD;
               5. Systemic lupus erythematosus&#xD;
&#xD;
               6. Systemic sclerosis&#xD;
&#xD;
               7. Ulcerative colitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants receiving investigational therapy within 30 days or 5 half-lives,&#xD;
             whichever is longer, prior to enrolment.&#xD;
&#xD;
          2. Participants suffering from any additional disease that may interfere with the&#xD;
             biomarker signals as per the investigator's discretion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Hillson, MD</last_name>
    <role>Study Director</role>
    <affiliation>Alpine Immune Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GI Research Institute</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Pack Arthritis Center</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</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>Sjogren's Syndrome</mesh_term>
    <mesh_term>Myositis</mesh_term>
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</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/NCT03757065
org study id: ALPN000-001
nct id: NCT03757065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to explore the expression of cell-surface markers in the following
      seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple
      sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g)
      inflammatory myositis.
observational model: Cohort
time perspective: Cross-Sectional
measure: CD28 Expression
time frame: At enrollment
description: Percentage of CD28+ T cells in peripheral blood
measure: ICOS Expression
time frame: At enrollment
description: Percentage of ICOS+ T cells in peripheral blood
arm group label: Systemic Lupus Erythematosus
arm group label: Sjogren's Syndrome
arm group label: Multiple Sclerosis
arm group label: Systemic Sclerosis
arm group label: Crohn's Disease
arm group label: Ulcerative Colitis
arm group label: Inflammatory Myositis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Hillson, MD
role: Study Director
affiliation: Alpine Immune Sciences
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Myositis
mesh term: Crohn Disease
mesh term: Multiple Sclerosis
mesh term: Lupus Erythematosus, Systemic
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis