<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/NCT01693393</url>
  </required_header>
  <id_info>
    <org_study_id>COLO400BDE02T</org_study_id>
    <nct_id>NCT01693393</nct_id>
  </id_info>
  <brief_title>Low Dose Cyclosporin A in Primary Sjögren Syndrome</brief_title>
  <acronym>CYPRESS</acronym>
  <official_title>A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary&#xD;
      Sjögren Syndrome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren&#xD;
      Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in&#xD;
      Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of&#xD;
      Sjögren Syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks.</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome</measure>
    <time_frame>28 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Study the general health changes and improvement of Sicca-symptoms</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of improvement of articular manifestations by ultrasound examination</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Sjögren´s Syndrome</condition>
  <arm_group>
    <arm_group_label>Cyclosporine A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporine A</intervention_name>
    <description>Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period</description>
    <arm_group_label>Cyclosporine A</arm_group_label>
    <other_name>Sandimmun optoral</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a primary Sjögren´s Syndrome&#xD;
&#xD;
          -  Liver values above 1,5 ULN&#xD;
&#xD;
          -  uncontrolled arterial hypertension&#xD;
&#xD;
          -  intraarticular or systemic use of Glucocorticoids in the last 4 weeks before&#xD;
&#xD;
          -  begin with Study medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-treatment with Cyclosporine A&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Neoplasia&#xD;
&#xD;
          -  relevant cardiac, pulmonary, neurologic or psychiatric disease&#xD;
&#xD;
          -  life-Vaccination within 4 weeks before begin with study medication&#xD;
&#xD;
          -  pregnant or breast-feeding&#xD;
&#xD;
          -  weight under 45kg or more than 110kg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugen Feist, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charite Universitätsklinikum Berlin Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Eugen Feist</investigator_full_name>
    <investigator_title>PD. Dr. med. Eugen Feist</investigator_title>
  </responsible_party>
  <keyword>primary Sjogren´s Syndrome</keyword>
  <keyword>Cyclosporine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Cyclosporins</mesh_term>
  </intervention_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/NCT01693393
org study id: COLO400BDE02T
nct id: NCT01693393
lead sponsor: 
has dmc: Yes
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary
      Sjögren Syndrome
NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren
      Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in
      Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of
      Sjögren Syndrome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks.
time frame: 16 weeks
measure: Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome
time frame: 28 weeks
measure: Study the general health changes and improvement of Sicca-symptoms
time frame: 16 weeks
measure: Documentation of improvement of articular manifestations by ultrasound examination
time frame: 16 weeks
arm group label: Cyclosporine A
arm group type: Other
description: All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks
intervention type: Drug
intervention name: Cyclosporine A
description: Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period
arm group label: Cyclosporine A
other name: Sandimmun optoral
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Eugen Feist, Dr. med.
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Eugen Feist
investigator title: PD. Dr. med. Eugen Feist
mesh term: Sjogren's Syndrome
mesh term: Syndrome
mesh term: Cyclosporine
mesh term: Cyclosporins