<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/NCT02188017</url>
  </required_header>
  <id_info>
    <org_study_id>ACPS</org_study_id>
    <nct_id>NCT02188017</nct_id>
  </id_info>
  <brief_title>Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)</brief_title>
  <acronym>ACPS</acronym>
  <official_title>ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mallinckrodt</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An randomized trial of two maintenance doses of Acthar Gel for patients with chronic&#xD;
      pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center double-blind trial to determine dose and effect size. A total of 20&#xD;
      chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the&#xD;
      United States.&#xD;
&#xD;
      After initial evaluation, including pulmonary function, CT and PET scanning, patients will be&#xD;
      randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80&#xD;
      units of Acthar gel twice a week for an additional 22 weeks.&#xD;
&#xD;
      At the end of total 24 weeks of treatment, they will undergo repeat evaluation including&#xD;
      pulmonary function, CT, and PET scanning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Steroid toxicity</measure>
    <time_frame>24 weeks</time_frame>
    <description>Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity (FVC)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in FVC over course of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chest x-ray</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in chest x-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET scan</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in lung uptake of PET scan during course of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcoidosis Health Questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Sarcoidosis</condition>
  <condition>Pulmonary Sarcoidosis</condition>
  <arm_group>
    <arm_group_label>80 units</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading</description>
  </arm_group>
  <arm_group>
    <arm_group_label>40 units</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 units of ACTHAR gel will be given twice a week for 22 weeks after loading</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acthar gel</intervention_name>
    <description>Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week</description>
    <arm_group_label>40 units</arm_group_label>
    <arm_group_label>80 units</arm_group_label>
    <other_name>ACTH</other_name>
    <other_name>Cortysin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria&#xD;
             23&#xD;
&#xD;
          -  Patient on &gt;5 mg prednisone for pulmonary indications&#xD;
&#xD;
          -  FVC &lt;85% predicted&#xD;
&#xD;
          -  Prednisone dose not reduced in prior 3 months&#xD;
&#xD;
          -  Deterioration of pulmonary disease over the past year&#xD;
&#xD;
          -  Decrease in FVC &gt;5%&#xD;
&#xD;
          -  Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had&#xD;
             their 91st birthday).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        adrenal insufficiency (Addison's disease)&#xD;
&#xD;
          -  Scleroderma&#xD;
&#xD;
          -  a fungal infection&#xD;
&#xD;
          -  herpes infection of the eyes&#xD;
&#xD;
          -  osteoporosis&#xD;
&#xD;
          -  a stomach ulcer&#xD;
&#xD;
          -  congestive heart failure&#xD;
&#xD;
          -  high blood pressure&#xD;
&#xD;
          -  recent surgery&#xD;
&#xD;
          -  if you are allergic to pork proteins&#xD;
&#xD;
          -  Do not receive a smallpox vaccine or any &quot;live&quot; vaccine while you are using&#xD;
             corticotropin.&#xD;
&#xD;
          -  Patients receiving anti-Tumor Necrosis Factor antibody (e.g. infliximab, adalimumab)&#xD;
             in prior six months&#xD;
&#xD;
          -  Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of&#xD;
             glucocorticoids&#xD;
&#xD;
          -  Patients requiring therapy for pulmonary hypertension&#xD;
&#xD;
          -  Females of childbearing potential who are known to be pregnant and/or lactating or who&#xD;
             have a positive urine pregnancy test on screening.&#xD;
&#xD;
          -  Current participation in another research drug treatment protocol (patient cannot&#xD;
             start another experimental agent until after 90 days)&#xD;
&#xD;
          -  Any other condition that the investigator feels would pose a significant hazard to the&#xD;
             patient if Acthar Gel therapy is initiated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert P Baughman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert P Baughman, MD</last_name>
    <phone>513-58405225</phone>
    <email>bob.baughman@uc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felicia Thompson</last_name>
      <phone>513-584-6252</phone>
      <email>THOMPSFA@ucmail.uc.edu</email>
    </contact>
    <investigator>
      <last_name>Robert P Baughman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>April 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>December 4, 2015</last_update_submitted>
  <last_update_submitted_qc>December 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Robert P Baughman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>prednisone, methotrexate, sarcoidosis, azathioprine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis, Pulmonary</mesh_term>
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 1, 2017</submitted>
    <returned>May 30, 2017</returned>
    <submitted>February 1, 2018</submitted>
    <returned>February 28, 2018</returned>
  </pending_results>
  <!-- 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/NCT02188017
org study id: ACPS
nct id: NCT02188017
lead sponsor: 
collaborator: 
has dmc: Yes
An randomized trial of two maintenance doses of Acthar Gel for patients with chronic
      pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.
This is a multi-center double-blind trial to determine dose and effect size. A total of 20
      chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the
      United States.

      After initial evaluation, including pulmonary function, CT and PET scanning, patients will be
      randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80
      units of Acthar gel twice a week for an additional 22 weeks.

      At the end of total 24 weeks of treatment, they will undergo repeat evaluation including
      pulmonary function, CT, and PET scanning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Steroid toxicity
time frame: 24 weeks
description: Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire
measure: Forced Vital Capacity (FVC)
time frame: 24 weeks
description: Change in FVC over course of study
measure: Chest x-ray
time frame: 24 weeks
description: Change in chest x-ray
measure: PET scan
time frame: 24 weeks
description: Change in lung uptake of PET scan during course of study
measure: Sarcoidosis Health Questionnaire
time frame: 24 weeks
description: Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire
arm group label: 80 units
arm group type: Active Comparator
description: 80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading
arm group label: 40 units
arm group type: Active Comparator
description: 40 units of ACTHAR gel will be given twice a week for 22 weeks after loading
intervention type: Drug
intervention name: Acthar gel
description: Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
arm group label: 40 units
arm group label: 80 units
other name: ACTH
other name: Cortysin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Robert P Baughman, MD
role: Principal Investigator
affiliation: University of Cincinnati
last name: Robert P Baughman, MD
phone: 513-58405225
email: bob.baughman@uc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Robert P Baughman
investigator title: Professor
mesh term: Sarcoidosis, Pulmonary
mesh term: Sarcoidosis
submitted: May 1, 2017
returned: May 30, 2017
submitted: February 1, 2018
returned: February 28, 2018