<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/NCT03839862</url>
  </required_header>
  <id_info>
    <org_study_id>FAST1</org_study_id>
    <nct_id>NCT03839862</nct_id>
  </id_info>
  <brief_title>Faecal Analyses in Spondyloarthritis Therapy</brief_title>
  <acronym>FAST</acronym>
  <official_title>Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the intestinal microbiome and disease activity in patients with&#xD;
      spondyloarthropathies receiving immunosuppressive therapy.&#xD;
&#xD;
      Patients will be analysed at two time points in reference to two predefined primary&#xD;
      endpoints:&#xD;
&#xD;
        -  Changes in intestinal microbiome&#xD;
&#xD;
        -  Response to therapy&#xD;
&#xD;
      The investigators want to evaluate if successful treatment of spondylarthropathy coincide&#xD;
      with specific changes in the gut flora.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tumor necrosis factor (TNF)-inhibition is an efficient medication for the treatment of&#xD;
      spondyloarthropathy. In a substantial number of cases however, these medications remain&#xD;
      ineffective. At present, the scientific community has limited understanding of why some&#xD;
      patients are resistant to this medication. The purpose of this study is to understand if the&#xD;
      gut flora may associate with treatment response.&#xD;
&#xD;
      Spondyloarthropathies are associated with inflammatory bowel diseases in terms of&#xD;
      epidemiology and molecular pathogenesis. Recent studies have also associated&#xD;
      spondyloarthropathies with intestinal dysbiosis.&#xD;
&#xD;
      This study is of observational character and integrated in the routine clinical care of&#xD;
      patients with spondyloarthropathies at the Rheumatology Clinic, Skane University Hospital,&#xD;
      Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two&#xD;
      time-points together with clinical evaluation of disease activity. With an estimated&#xD;
      inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be&#xD;
      included and to be compared to each other.&#xD;
&#xD;
      Our primary goal is to investigate the association between change in intestinal microbiome&#xD;
      and clinical response to therapy.&#xD;
&#xD;
      In our secondary analyses we will investigate if intestinal microbiome and intestinal&#xD;
      inflammation at baseline may predict response to, and adherence to, therapy in these&#xD;
      patients.&#xD;
&#xD;
      If successful treatment response of spondyloarthropathy is associated with specific&#xD;
      alterations of the gut flora, these results may guide future studies on the impact of&#xD;
      dysbiosis and probiotics on this disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gut flora</measure>
    <time_frame>Change from baseline Dysbiosis Index Score at 6 months</time_frame>
    <description>Change in Dysbiosis Index Score att follow up compared to baseline. The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in disease activity/treatment response at follow up</measure>
    <time_frame>Change from baseline BASDAI at 6 months</time_frame>
    <description>Change in Bath Ankylosing Spondylitis Disease Activity Score (BASDAI), an established index of disease activity in spondylarthropathies between 0-10, where 10 equals maximum activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intestinal gut flora in spondyloarthropathies</measure>
    <time_frame>Analysis made at study start /baseline</time_frame>
    <description>Intestinal gut flora based on DNA-based microbial analysis of fecal samples (Dysbiosis Index Score). The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal gut inflammation</measure>
    <time_frame>Analysis made at study start /baseline</time_frame>
    <description>Assessment of intestinal inflammation by measurement of faecal calprotectin, an established biomarker of intestinal inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to immunosuppressive therapy</measure>
    <time_frame>Analysis made at 6 months follow up</time_frame>
    <description>Is the patient still prescribed the same immunosuppressant compared to baseline?</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Spondyloarthropathies</condition>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Responder</arm_group_label>
    <description>Patient responding to TNF-inhibition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-Responder</arm_group_label>
    <description>Patient not responding to TNF-inhibition</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TNF-inhibition</intervention_name>
    <description>Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab</description>
    <arm_group_label>Responder</arm_group_label>
    <arm_group_label>non-Responder</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and faecal sampling&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study encompasses consecutive patients with spondyloarthropathy who by their physician&#xD;
        at the Rheumatology Clinic, Skåne University Hospital, have been prescribed a&#xD;
        TNF-inhibitor.&#xD;
&#xD;
        Patients who are willing to comply with the study protocoll are included. The study&#xD;
        population is consequently not a sample, but encompasses a majority of spondyloarthropathy&#xD;
        patients being prescribed this medication at our University clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfilling the Assessment of SpondyloArthritis International Society classification&#xD;
             criteria for spondyloarthropathy.&#xD;
&#xD;
          -  About to commence treatment with TNF-inhibition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to understand protocol&#xD;
&#xD;
          -  A history of alcohol abuse&#xD;
&#xD;
          -  Any history of diverticulitis&#xD;
&#xD;
          -  A history of failure to comply with prescribed medication&#xD;
&#xD;
          -  Ongoing biological therapy&#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>Kristofer Andréasson, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kristofer Andréasson, MD PhD</last_name>
    <phone>+4646172153</phone>
    <email>kristofer.andreasson@med.lu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Johan Karlsson Wallman, MD PhD</last_name>
    <phone>+4646172140</phone>
    <email>johan.81.karlsson@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Reumatologi SUS Lund, Region Skåne</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristofer Andréasson, MD PhD</last_name>
      <phone>+4646171000</phone>
      <email>kristofer.andreasson@med.lu.se</email>
    </contact>
    <contact_backup>
      <last_name>Johan Karlsson Wallman, MD PhD</last_name>
      <phone>+4646171000</phone>
      <email>johan.81.karlsson@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 18, 2020</last_update_submitted>
  <last_update_submitted_qc>March 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 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>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Spondylarthropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03839862
org study id: FAST1
nct id: NCT03839862
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study evaluates the intestinal microbiome and disease activity in patients with
      spondyloarthropathies receiving immunosuppressive therapy.

      Patients will be analysed at two time points in reference to two predefined primary
      endpoints:

        -  Changes in intestinal microbiome

        -  Response to therapy

      The investigators want to evaluate if successful treatment of spondylarthropathy coincide
      with specific changes in the gut flora.
Tumor necrosis factor (TNF)-inhibition is an efficient medication for the treatment of
      spondyloarthropathy. In a substantial number of cases however, these medications remain
      ineffective. At present, the scientific community has limited understanding of why some
      patients are resistant to this medication. The purpose of this study is to understand if the
      gut flora may associate with treatment response.

      Spondyloarthropathies are associated with inflammatory bowel diseases in terms of
      epidemiology and molecular pathogenesis. Recent studies have also associated
      spondyloarthropathies with intestinal dysbiosis.

      This study is of observational character and integrated in the routine clinical care of
      patients with spondyloarthropathies at the Rheumatology Clinic, Skane University Hospital,
      Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two
      time-points together with clinical evaluation of disease activity. With an estimated
      inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be
      included and to be compared to each other.

      Our primary goal is to investigate the association between change in intestinal microbiome
      and clinical response to therapy.

      In our secondary analyses we will investigate if intestinal microbiome and intestinal
      inflammation at baseline may predict response to, and adherence to, therapy in these
      patients.

      If successful treatment response of spondyloarthropathy is associated with specific
      alterations of the gut flora, these results may guide future studies on the impact of
      dysbiosis and probiotics on this disease.
observational model: Cohort
time perspective: Prospective
measure: Change in gut flora
time frame: Change from baseline Dysbiosis Index Score at 6 months
description: Change in Dysbiosis Index Score att follow up compared to baseline. The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.
measure: Change in disease activity/treatment response at follow up
time frame: Change from baseline BASDAI at 6 months
description: Change in Bath Ankylosing Spondylitis Disease Activity Score (BASDAI), an established index of disease activity in spondylarthropathies between 0-10, where 10 equals maximum activity
measure: Intestinal gut flora in spondyloarthropathies
time frame: Analysis made at study start /baseline
description: Intestinal gut flora based on DNA-based microbial analysis of fecal samples (Dysbiosis Index Score). The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.
measure: Intestinal gut inflammation
time frame: Analysis made at study start /baseline
description: Assessment of intestinal inflammation by measurement of faecal calprotectin, an established biomarker of intestinal inflammation
measure: Adherence to immunosuppressive therapy
time frame: Analysis made at 6 months follow up
description: Is the patient still prescribed the same immunosuppressant compared to baseline?
arm group label: Responder
description: Patient responding to TNF-inhibition
arm group label: non-Responder
description: Patient not responding to TNF-inhibition
intervention type: Drug
intervention name: TNF-inhibition
description: Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab
arm group label: Responder
arm group label: non-Responder
Blood and faecal sampling
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristofer Andréasson, MD PhD
role: Principal Investigator
affiliation: Lund University Hospital
last name: Kristofer Andréasson, MD PhD
phone: +4646172153
email: kristofer.andreasson@med.lu.se
last name: Johan Karlsson Wallman, MD PhD
phone: +4646172140
email: johan.81.karlsson@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Spondylarthropathies
sharing ipd: No