<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/NCT01718951</url>
  </required_header>
  <id_info>
    <org_study_id>CREC/769/09</org_study_id>
    <nct_id>NCT01718951</nct_id>
  </id_info>
  <brief_title>Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial</brief_title>
  <official_title>Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tuen Mun Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tuen Mun Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy of golimumab with pamidronate in the treatment of axial&#xD;
      spondyloarthropathy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological&#xD;
      axial spondyloarthropathy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response</measure>
    <time_frame>week 48</time_frame>
    <description>Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in MRI spinal inflammation scores</measure>
    <time_frame>week 24 and 48</time_frame>
    <description>Changes in MRI spinal inflammation scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Spondyloarthropathy</condition>
  <arm_group>
    <arm_group_label>golimumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>golimumab 50mg subcutaneous every 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pamidronate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pamidronate (60mg) intravenously every 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>golimumab</intervention_name>
    <description>golimumab</description>
    <arm_group_label>golimumab</arm_group_label>
    <other_name>Simponi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pamidronate</intervention_name>
    <description>pamidronate</description>
    <arm_group_label>pamidronate</arm_group_label>
    <other_name>Aridia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects greater than 18 years of age&#xD;
&#xD;
          2. Fulfilling the latest classification criteria for axial spondyloarthropathy&#xD;
&#xD;
          3. Active spondylitis as defined by a Bath Ankylosing Spondylitis Disease Activity Index&#xD;
             (BASDAI) score of more than 4 despite treatment with non-steroid anti-inflammatory&#xD;
             drugs for more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Major surgery (including joint surgery) within 8 weeks prior to study entry&#xD;
&#xD;
          2. History of treatment with anti-tumor necrosis factor agents or any investigational&#xD;
             therapies within 12 months of study entry&#xD;
&#xD;
          3. Immunization with a live/attenuated vaccine within 4 weeks prior to study entry&#xD;
&#xD;
          4. Active current bacterial, viral, fungal, mycobacterial or other infections at study&#xD;
             entry&#xD;
&#xD;
          5. Chronic hepatitis B or hepatitis C carriers&#xD;
&#xD;
          6. History of malignancies, including solid tumors and hemic malignancies&#xD;
&#xD;
          7. History of congestive heart failure&#xD;
&#xD;
          8. History of demyelinating disorders&#xD;
&#xD;
          9. History of peripheral neuropathy&#xD;
&#xD;
         10. Pregnant women or lactating mothers&#xD;
&#xD;
         11. Baseline liver parenchymal enzymes elevated to more than 2 times normal&#xD;
&#xD;
         12. Absolute lymphocyte count less than 500/mm3&#xD;
&#xD;
         13. Serum creatinine level of more than 200umol/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tuen Mun Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>May 11, 2015</last_update_submitted>
  <last_update_submitted_qc>May 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tuen Mun Hospital</investigator_affiliation>
    <investigator_full_name>Chi Chiu Mok</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>spondyloarthropathy</keyword>
  <keyword>ankylosing spondylitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthropathies</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pamidronate</mesh_term>
    <mesh_term>Golimumab</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/NCT01718951
org study id: CREC/769/09
nct id: NCT01718951
lead sponsor: 
has dmc: No
To compare the efficacy of golimumab with pamidronate in the treatment of axial
      spondyloarthropathy
To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological
      axial spondyloarthropathy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response
time frame: week 48
description: Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response
measure: Changes in MRI spinal inflammation scores
time frame: week 24 and 48
description: Changes in MRI spinal inflammation scores
arm group label: golimumab
arm group type: Active Comparator
description: golimumab 50mg subcutaneous every 4 weeks
arm group label: pamidronate
arm group type: Active Comparator
description: Pamidronate (60mg) intravenously every 4 weeks
intervention type: Drug
intervention name: golimumab
description: golimumab
arm group label: golimumab
other name: Simponi
intervention type: Drug
intervention name: Pamidronate
description: pamidronate
arm group label: pamidronate
other name: Aridia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Tuen Mun Hospital
investigator full name: Chi Chiu Mok
investigator title: Consultant
mesh term: Spondylitis
mesh term: Spondylarthropathies
mesh term: Spondylarthritis
mesh term: Pamidronate
mesh term: Golimumab