<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/NCT03270501</url>
  </required_header>
  <id_info>
    <org_study_id>GO-GUT trial</org_study_id>
    <nct_id>NCT03270501</nct_id>
  </id_info>
  <brief_title>Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation</brief_title>
  <acronym>GO-GUT</acronym>
  <official_title>Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation, an Early Remission Induction Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>the Flanders Institute for Biotechnology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of the study is that the presence of (subclinical) gut inflammation at&#xD;
      baseline in patients with early active axial spondyloarthritis predisposes to a more severe&#xD;
      disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time&#xD;
      to relapse after stopping anti-tumor necrosis factor α therapy after obtaining sustained&#xD;
      clinical remission. Overall, the investigators hypothesize that subclinical gut inflammation&#xD;
      is an important predictor in therapy response and outcome. These data could provide better&#xD;
      insights into the complex interactions between gut and joint inflammation and guide the&#xD;
      physicians in the therapeutic approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 3</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>clinical remission</measure>
    <time_frame>week 16</time_frame>
    <description>Ankylosing Spondylitis Disease Activity Score (ASDAS) &lt; 1.3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intestinal mucosal healing</measure>
    <time_frame>week 16</time_frame>
    <description>evaluated by ileocolonoscopy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">147</enrollment>
  <condition>Axial Spondyloarthritis</condition>
  <arm_group>
    <arm_group_label>Arm 1: Golimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Golimumab</intervention_name>
    <description>Axial spondyloarthritis patients who don't have a good treatment response on 2 NSAIDs, will be treated with golimumab. After remission, the therapy will be stopped.&#xD;
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.</description>
    <arm_group_label>Arm 1: Golimumab</arm_group_label>
    <other_name>ileocoloscopy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have a diagnosis of axSpA and classified according to ASAS criteria.&#xD;
&#xD;
          -  Subject has at least 3 months and maximum 1 year (almost) daily chronic back pain.&#xD;
&#xD;
          -  Subject has an active disease defined as a positive MRI (according to ASAS definition)&#xD;
             or elevated CRP (in patients who are HLA-B27+) and an ASDAS score &gt; 2.1 (at least high&#xD;
             disease activity).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Full anti-inflammatory dose of NSAIDs for more than 4 weeks for the duration of the&#xD;
             axSpA symptoms.&#xD;
&#xD;
          -  Prior exposure to any biologic therapy with a potential therapeutic impact on SpA,&#xD;
             including anti-TNF therapy.&#xD;
&#xD;
          -  Exposure to disease-modifying drugs (DMARDSs; i.e. methotrexate and sulfasalazine) in&#xD;
             the last 3 months before the ileocolonoscopy.&#xD;
&#xD;
          -  Exposure to systemic corticosteroid treatment in the last 14 days before the&#xD;
             ileocolonoscopy.&#xD;
&#xD;
          -  Infection(s) requiring treatment with intravenous antibiotics/antivirals/antifungals&#xD;
             within 30 days prior to the baseline visit or oral antibiotics/antivirals/antifungals&#xD;
             within 14 days prior to the baseline visit.&#xD;
&#xD;
          -  Have a known hypersensitivity to human immunoglobulin proteins or other components of&#xD;
             golimumab.&#xD;
&#xD;
          -  History of central nervous system (CNS) demyelinating disease or neurologic symptoms&#xD;
             suggestive of CNS demyelinating disease.&#xD;
&#xD;
          -  History of listeriosis, histoplasmosis, chronic of active hepatitis B infection,&#xD;
             hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency&#xD;
             syndrome, chronic recurring infections or active tuberculosis.&#xD;
&#xD;
          -  Have a history of, or concurrent, chronic heart failure, including medically&#xD;
             controlled, asymptomatic congestive heart failure.&#xD;
&#xD;
          -  Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other&#xD;
             than a successfully treated non-metastatic cutaneous squamous cell or basal cell&#xD;
             carcinoma or localized carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Have received, or are expected to receive, any live virus or bacterial vaccination&#xD;
             within 3 months prior to the first administration of study agent, during the trial, or&#xD;
             within 6 months after the last administration of study agent.&#xD;
&#xD;
          -  Positive pregnancy test at screening.&#xD;
&#xD;
          -  Female subjects who are breast-feeding or considering becoming pregnant during the&#xD;
             study.&#xD;
&#xD;
          -  Female subjects who do not use contraceptives.&#xD;
&#xD;
          -  History of clinically significant drug or alcohol abuse in the last 12 months.&#xD;
&#xD;
          -  Clinically significant abnormal screening laboratory results as evaluated by the&#xD;
             investigator.&#xD;
&#xD;
          -  Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP)&#xD;
             antibody at screening if the titers are crossing 3 times the upper limit of the&#xD;
             normal.&#xD;
&#xD;
          -  Subject with diagnosis and current symptoms of fibromyalgia.&#xD;
&#xD;
          -  Any medical or psychological condition that, in the opinion of the investigator, could&#xD;
             jeopardize or compromise the subject's ability to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk Elewaut</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Renson</last_name>
    <phone>+32332 22 28</phone>
    <email>thomas.renson@ugent.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anuschka Van Den Bogaert</last_name>
    <email>anuschka.vandenbogaert@ugent.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Imelda Bonheiden</name>
      <address>
        <city>Bonheiden</city>
        <state>Antwerpen</state>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stijn Michiels, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <state>B - Belgium</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Renson</last_name>
      <phone>+3293322228</phone>
      <email>thomas.renson@ugent.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Reuma Instituut Hasselt</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Lenaerts, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011 Jun 18;377(9783):2127-37. doi: 10.1016/S0140-6736(11)60071-8.</citation>
    <PMID>21684383</PMID>
  </reference>
  <reference>
    <citation>Mielants H, Veys EM, Cuvelier C, De Vos M, Botelberghe L. HLA-B27 related arthritis and bowel inflammation. Part 2. Ileocolonoscopy and bowel histology in patients with HLA-B27 related arthritis. J Rheumatol. 1985 Apr;12(2):294-8.</citation>
    <PMID>3875721</PMID>
  </reference>
  <reference>
    <citation>Van Praet L, Van den Bosch FE, Jacques P, Carron P, Jans L, Colman R, Glorieus E, Peeters H, Mielants H, De Vos M, Cuvelier C, Elewaut D. Microscopic gut inflammation in axial spondyloarthritis: a multiparametric predictive model. Ann Rheum Dis. 2013 Mar;72(3):414-7. doi: 10.1136/annrheumdis-2012-202135. Epub 2012 Nov 8.</citation>
    <PMID>23139267</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</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>Axial Spondyloarthritis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Golimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03270501
org study id: GO-GUT trial
nct id: NCT03270501
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The hypothesis of the study is that the presence of (subclinical) gut inflammation at
      baseline in patients with early active axial spondyloarthritis predisposes to a more severe
      disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time
      to relapse after stopping anti-tumor necrosis factor α therapy after obtaining sustained
      clinical remission. Overall, the investigators hypothesize that subclinical gut inflammation
      is an important predictor in therapy response and outcome. These data could provide better
      insights into the complex interactions between gut and joint inflammation and guide the
      physicians in the therapeutic approach.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical remission
time frame: week 16
description: Ankylosing Spondylitis Disease Activity Score (ASDAS) < 1.3
measure: intestinal mucosal healing
time frame: week 16
description: evaluated by ileocolonoscopy
arm group label: Arm 1: Golimumab
arm group type: Experimental
intervention type: Drug
intervention name: Golimumab
description: Axial spondyloarthritis patients who don't have a good treatment response on 2 NSAIDs, will be treated with golimumab. After remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
arm group label: Arm 1: Golimumab
other name: ileocoloscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
last name: Dirk Elewaut
role: Principal Investigator
affiliation: University Ghent
last name: Thomas Renson
phone: +32332 22 28
email: thomas.renson@ugent.be
last name: Anuschka Van Den Bogaert
email: anuschka.vandenbogaert@ugent.be
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Belgium
citation: Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011 Jun 18;377(9783):2127-37. doi: 10.1016/S0140-6736(11)60071-8.
PMID: 21684383
citation: Mielants H, Veys EM, Cuvelier C, De Vos M, Botelberghe L. HLA-B27 related arthritis and bowel inflammation. Part 2. Ileocolonoscopy and bowel histology in patients with HLA-B27 related arthritis. J Rheumatol. 1985 Apr;12(2):294-8.
PMID: 3875721
citation: Van Praet L, Van den Bosch FE, Jacques P, Carron P, Jans L, Colman R, Glorieus E, Peeters H, Mielants H, De Vos M, Cuvelier C, Elewaut D. Microscopic gut inflammation in axial spondyloarthritis: a multiparametric predictive model. Ann Rheum Dis. 2013 Mar;72(3):414-7. doi: 10.1136/annrheumdis-2012-202135. Epub 2012 Nov 8.
PMID: 23139267
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
mesh term: Inflammation
mesh term: Golimumab
sharing ipd: Undecided