<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/NCT02186873</url>
  </required_header>
  <id_info>
    <org_study_id>CR103795</org_study_id>
    <secondary_id>CNTO148AKS3001</secondary_id>
    <secondary_id>2014-000241-74</secondary_id>
    <nct_id>NCT02186873</nct_id>
  </id_info>
  <brief_title>A Study of Golimumab in Participants With Active Ankylosing Spondylitis</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of intravenously (administration of a&#xD;
      fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants&#xD;
      with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that&#xD;
      involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral&#xD;
      joints).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 3, multicenter (when more than one hospital or medical school team work on a&#xD;
      medical research study), randomized (study drug assigned by chance), double-blind (neither&#xD;
      the researchers nor the participants know what treatment the participant is receiving),&#xD;
      placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is&#xD;
      compared in a clinical trial with a drug to test if the drug has a real effect) study of&#xD;
      golimumab compared with placebo in participants with active ankylosing spondylitis. The study&#xD;
      comprises of 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase&#xD;
      (Week 0 to Week 16), Active treatment phase (Week 16 to Week 52), and Safety follow-up phase&#xD;
      (8 weeks from last study drug administration). Total duration of the study will be 60 weeks&#xD;
      per participant. Eligible Participants will be randomly assigned to either Treatment group 1:&#xD;
      Placebo or Treatment group 2: Golimumab. Participants randomized to Placebo group, will&#xD;
      receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants&#xD;
      receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Weeks&#xD;
      16, 20 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab&#xD;
      group, will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter&#xD;
      every 8 weeks up to Week 52. At Week 16, participants randomized to golimumab group will&#xD;
      receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by&#xD;
      measuring percentage of participants who achieve a 20 percent improvement from baseline in&#xD;
      the assessment in ankylosing spondylitis (ASAS) at Week 16. Participant's safety will be&#xD;
      monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2014</start_date>
  <completion_date type="Actual">October 11, 2016</completion_date>
  <primary_completion_date type="Actual">December 15, 2015</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (&gt;=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as &gt;=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>An ASAS 40 response is defined as &gt;=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of &quot;yes&quot; on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Treatment Group 1: Placebo then Golimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group 2: Golimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive matching placebo.</description>
    <arm_group_label>Treatment Group 1: Placebo then Golimumab</arm_group_label>
    <arm_group_label>Treatment Group 2: Golimumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Golimumab</intervention_name>
    <description>Participants will receive 2mg/kg of intravenous infusions of golimumab .</description>
    <arm_group_label>Treatment Group 1: Placebo then Golimumab</arm_group_label>
    <arm_group_label>Treatment Group 2: Golimumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with diagnosis of definite ankylosing spondylitis for at least 3 months&#xD;
             based on modified New York radiographic and clinical criteria&#xD;
&#xD;
          -  Participants with symptoms of active disease at screening and at baseline&#xD;
&#xD;
          -  Participant has either an inadequate response to at least 2 non-steroidal&#xD;
             anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended&#xD;
             doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy&#xD;
             because of intolerance, toxicity, or contraindications to NSAIDs&#xD;
&#xD;
          -  Participants with C- reactive protein (CRP) level of greater than or equal to (&gt;=) 0.3&#xD;
             milligram per deciliter (mg/dL) at screening&#xD;
&#xD;
          -  Additional protocol-defined inclusion criteria apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant with other inflammatory diseases that might confound the evaluations of&#xD;
             benefit from the golimumab therapy&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Participants with chest radiograph within 3 months prior to the first administration&#xD;
             of study agent that shows an abnormality suggestive of a malignancy or current active&#xD;
             infection, including tuberculosis&#xD;
&#xD;
          -  Participants who had a serious infection (including but not limited to, hepatitis,&#xD;
             pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or&#xD;
             have been treated with intravenous (IV) antibiotics for an infection within 2 months&#xD;
             prior to first administration of study agent&#xD;
&#xD;
          -  Additional protocol-defined exclusion criteria apply&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Palma</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Granger</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orchard Park</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Maroochydore</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint-John'S</city>
        <state>Newfoundland and Labrador</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. John'S</city>
        <state>Newfoundland and Labrador</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burlington</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Trois-Rivieres</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bad Doberan</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Erfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Planegg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ratingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zerbst</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ansan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seongdong-Gu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chihuahua</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bytom</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nadarzyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nowa Sól</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saratov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Smolensk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tver</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chernihiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dnipropetrovsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Odessa</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zaporizhzhia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>Romania</country>
  </removed_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>October 11, 2017</results_first_submitted>
  <results_first_submitted_qc>October 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2017</results_first_posted>
  <disposition_first_submitted>July 19, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>July 19, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 21, 2016</disposition_first_posted>
  <last_update_submitted>November 28, 2017</last_update_submitted>
  <last_update_submitted_qc>November 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ankylosing Spondylitis</keyword>
  <keyword>Golimumab</keyword>
  <keyword>SIMPONI</keyword>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Golimumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram [mg/kg] and 103 to placebo group) and treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: Placebo Then Golimumab</title>
          <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: Golimumab</title>
          <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>End of Control Period</title>
              <participants_list>
                <participants group_id="P1" count="99">Participants taking placebo crossed over to golimumab</participants>
                <participants group_id="P2" count="105">Participants continued to receive golimumab</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1: Placebo Then Golimumab</title>
          <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: Golimumab</title>
          <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="103"/>
            <count group_id="B2" value="105"/>
            <count group_id="B3" value="208"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.2" spread="10.75"/>
                    <measurement group_id="B2" value="38.4" spread="10.11"/>
                    <measurement group_id="B3" value="38.8" spread="10.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russian Federation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16</title>
        <description>An ASAS 40 response is defined as &gt;=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.</description>
        <time_frame>Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16</title>
          <description>An ASAS 40 response is defined as &gt;=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.</description>
          <population>FAS included all participants who were randomized in the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7"/>
                    <measurement group_id="O2" value="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16</title>
        <description>The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.</description>
        <time_frame>Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16</title>
          <description>The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.</description>
          <population>FAS included all participants who were randomized in the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6"/>
                    <measurement group_id="O2" value="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16</title>
        <description>The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16</title>
          <description>The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.</description>
          <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.471" spread="1.9558"/>
                    <measurement group_id="O2" value="-2.386" spread="2.1300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16</title>
        <description>ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (&gt;=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as &gt;=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.</description>
        <time_frame>Week 16</time_frame>
        <population>The full analysis set (FAS) included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16</title>
          <description>ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (&gt;=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as &gt;=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.</description>
          <population>The full analysis set (FAS) included all participants who were randomized in the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2"/>
                    <measurement group_id="O2" value="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>47.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.18</ci_lower_limit>
            <ci_upper_limit>58.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16</title>
        <description>The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16</title>
          <description>The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.</description>
          <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" spread="6.177"/>
                    <measurement group_id="O2" value="8.52" spread="7.535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16</title>
        <description>The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16</title>
          <description>The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.</description>
          <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="10.004"/>
                    <measurement group_id="O2" value="6.47" spread="9.122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16</title>
        <description>Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.</description>
        <time_frame>Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16</title>
          <description>Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.</description>
          <population>FAS included all participants who were randomized in the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9"/>
                    <measurement group_id="O2" value="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16</title>
        <description>The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of &quot;yes&quot; on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16</title>
          <description>The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of &quot;yes&quot; on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.</description>
          <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Units on Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="4.57"/>
                    <measurement group_id="O2" value="-5.4" spread="5.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16</title>
        <description>BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Placebo Then Golimumab</title>
            <description>Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Golimumab</title>
            <description>Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16</title>
          <description>BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.</description>
          <population>FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Units on Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.539"/>
                    <measurement group_id="O2" value="-0.38" spread="0.625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 60 weeks</time_frame>
      <desc>Safety Analysis set included all participants who received at least 1 dose of study drug. Participants who received placebo and crossed over to golimumab were included in placebo then golimumab 2 mg/kg arm and who received at least 1 dose of golimumab were included in placebo then golimumab 2 mg/kg and golimumab 2 mg/kg arms for safety analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Then Golimumab 2 mg/kg</title>
          <description>Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group.</description>
        </group>
        <group group_id="E3">
          <title>Golimumab 2 mg/kg</title>
          <description>Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Non-alcoholic steatohepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Henoch-Schonlein purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director Clinical Development, Immunology General</name_or_title>
      <organization>Johnson&amp;Johnson</organization>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02186873
org study id: CR103795
secondary id: CNTO148AKS3001
secondary id: 2014-000241-74
nct id: NCT02186873
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
The purpose of this study is to evaluate the efficacy of intravenously (administration of a
      fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants
      with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that
      involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral
      joints).
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a
      medical research study), randomized (study drug assigned by chance), double-blind (neither
      the researchers nor the participants know what treatment the participant is receiving),
      placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is
      compared in a clinical trial with a drug to test if the drug has a real effect) study of
      golimumab compared with placebo in participants with active ankylosing spondylitis. The study
      comprises of 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase
      (Week 0 to Week 16), Active treatment phase (Week 16 to Week 52), and Safety follow-up phase
      (8 weeks from last study drug administration). Total duration of the study will be 60 weeks
      per participant. Eligible Participants will be randomly assigned to either Treatment group 1:
      Placebo or Treatment group 2: Golimumab. Participants randomized to Placebo group, will
      receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants
      receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Weeks
      16, 20 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab
      group, will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter
      every 8 weeks up to Week 52. At Week 16, participants randomized to golimumab group will
      receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by
      measuring percentage of participants who achieve a 20 percent improvement from baseline in
      the assessment in ankylosing spondylitis (ASAS) at Week 16. Participant's safety will be
      monitored throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
time frame: Week 16
description: ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.
measure: Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
time frame: Week 16
description: An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.
measure: Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
time frame: Week 16
description: The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
time frame: Baseline and Week 16
description: The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.
measure: Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
time frame: Baseline and Week 16
description: The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
measure: Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
time frame: Baseline and Week 16
description: The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
measure: Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16
time frame: Week 16
description: Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.
measure: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
time frame: Baseline and Week 16
description: The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
time frame: Baseline and Week 16
description: BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.
arm group label: Treatment Group 1: Placebo then Golimumab
arm group type: Experimental
description: Participants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52.
arm group label: Treatment Group 2: Golimumab
arm group type: Experimental
description: Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind.
intervention type: Drug
intervention name: Placebo
description: Participants will receive matching placebo.
arm group label: Treatment Group 1: Placebo then Golimumab
arm group label: Treatment Group 2: Golimumab
intervention type: Drug
intervention name: Golimumab
description: Participants will receive 2mg/kg of intravenous infusions of golimumab .
arm group label: Treatment Group 1: Placebo then Golimumab
arm group label: Treatment Group 2: Golimumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Australia
country: Canada
country: Germany
country: Korea, Republic of
country: Mexico
country: Poland
country: Russian Federation
country: Ukraine
country: United States
country: Brazil
country: Romania
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Golimumab
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