<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/NCT01692457</url>
  </required_header>
  <id_info>
    <org_study_id>CR100823</org_study_id>
    <secondary_id>CNTO148AKS4003</secondary_id>
    <secondary_id>SIM-PHL-MA1</secondary_id>
    <secondary_id>GLR-C-12-PH-001-V01</secondary_id>
    <nct_id>NCT01692457</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis</brief_title>
  <official_title>A Post-Marketing Surveillance Study on the Safety and Effectiveness of Golimumab (Simponi) Among Adult Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and effectiveness of golimumab for the&#xD;
      treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among&#xD;
      Filipino patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), multi-center (study&#xD;
      conducted at multiple sites), observational study (study in which the investigators/&#xD;
      physicians observe the patients and measure their outcomes) to evaluate the safety and&#xD;
      effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and&#xD;
      ankylosing spondylitis among Filipino patients.&#xD;
&#xD;
      The study will enroll approximately 50 patients who would use golimumab with a dosing regimen&#xD;
      stipulated in the product insert. As this is an observational study, assessment of patients&#xD;
      will be based on the accepted clinical practice in the Philippines. Patients will be&#xD;
      monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety&#xD;
      evaluations for adverse events, clinical laboratory tests, physical examination, concomitant&#xD;
      medications, and co-morbid conditions will be monitored throughout the study. The total study&#xD;
      will be conducted for 3 years and duration of treatment will be for 24 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The company decided to cancel the study in conformity with Philippine FDA Circular 2013-004&#xD;
  </why_stopped>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with incidence of adverse events</measure>
    <time_frame>From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with incidence of discontinuation of study medication due to adverse events</measure>
    <time_frame>From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score</measure>
    <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, and 24</time_frame>
    <description>HAQ will include 2 scales: (a) scale for evaluating disability (score range, 0 [without any difficulty] to 3 [unable to do]) and (b) Visual Analogue Scale for evaluating discomfort and pain (score range, 0 [no pain] to 100 [severe pain]).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Golimumab</arm_group_label>
    <description>Patients will be taking golimumab as per the dosing regimen given on product insert approved in Philippines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is an observational study. Golimumab will be administered as per the recommended doses. Golimumab 50 mg will be given as a subcutaneous injection once a month, on the same date each month. For rheumatoid arthritis: Golimumab 2 mg/kg will be given as a 30 minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter.</description>
    <arm_group_label>Golimumab</arm_group_label>
    <other_name>SIMPONI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Filipino patients with rheumatoid arthritis, psoriatic arthritis and ankylosing&#xD;
        spondylitis; and who are on the approved product label of golimumab.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have rheumatoid arthritis and exhibit at least four of the following criteria: morning&#xD;
             stiffness for at least one hour and present for at least six weeks, swelling of three&#xD;
             or more joints for at least six weeks, swelling of wrist, metacarpophalangeal or&#xD;
             proximal interphalangeal joints for six or more weeks, symmetrical joint swelling,&#xD;
             X-ray changes of hand that include erosions or unequivocal bony decalcification,&#xD;
             rheumatoid nodules, serum rheumatoid factor by a method positive in less than 5&#xD;
             percent of normal&#xD;
&#xD;
          -  Have ankylosing spondylitis and must have either of the following: Grade 3-4&#xD;
             sacroiliitis with at least one clinical criterion, Grade 3-4 unilateral sacroiliitis,&#xD;
             Grade 2 bilateral sacroiliitis with clinical criterion 1 (limitation of motion of the&#xD;
             lumbar spine in all 3 planes: anterior flexion, lateral flexion, extension) or&#xD;
             criterion 2 (history of pain in the lumbar spine or at the dorso-lumbar junction) and&#xD;
             criterion 3 (limited chest expansion to 2.5 cm or less, measured at the fourth&#xD;
             intercostals line)&#xD;
&#xD;
          -  Have psoriatic arthritis and includes 3 of the following conditions: an inflammatory&#xD;
             arthritis (peripheral arthritis and/or sacroiliitis or spondylitis), the presence of&#xD;
             psoriasis, the (usual) absence of serological tests for rheumatoid factor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to golimumab or to any of the components of the agent&#xD;
             preparation&#xD;
&#xD;
          -  Pregnant or breastfeeding females&#xD;
&#xD;
          -  Not agreeing to protocol-defined use of effective contraception&#xD;
&#xD;
          -  Patients receiving live vaccines while on treatment&#xD;
&#xD;
          -  Patients with documented clinically important, active infection (eg, active&#xD;
             tuberculosis infection)&#xD;
&#xD;
          -  Patients with documented past and current history of malignancy and significant&#xD;
             cytopenias (reduction in the number of blood cells)&#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 Pharmaceutica Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica</affiliation>
  </overall_official>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Psoriatic Arthritis</keyword>
  <keyword>Ankylosing Spondylitis</keyword>
  <keyword>Arthritis</keyword>
  <keyword>Spondylitis</keyword>
  <keyword>Joint pain</keyword>
  <keyword>CNTO148</keyword>
  <keyword>Golimumab</keyword>
  <keyword>Simponi</keyword>
  <keyword>Filipino</keyword>
  <keyword>Post-Marketing</keyword>
  <keyword>Surveillance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Arthritis, Psoriatic</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>
  <!-- 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/NCT01692457
org study id: CR100823
secondary id: CNTO148AKS4003
secondary id: SIM-PHL-MA1
secondary id: GLR-C-12-PH-001-V01
nct id: NCT01692457
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and effectiveness of golimumab for the
      treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among
      Filipino patients.
This is an open-label (all people know the identity of the intervention), multi-center (study
      conducted at multiple sites), observational study (study in which the investigators/
      physicians observe the patients and measure their outcomes) to evaluate the safety and
      effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and
      ankylosing spondylitis among Filipino patients.

      The study will enroll approximately 50 patients who would use golimumab with a dosing regimen
      stipulated in the product insert. As this is an observational study, assessment of patients
      will be based on the accepted clinical practice in the Philippines. Patients will be
      monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety
      evaluations for adverse events, clinical laboratory tests, physical examination, concomitant
      medications, and co-morbid conditions will be monitored throughout the study. The total study
      will be conducted for 3 years and duration of treatment will be for 24 weeks.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with incidence of adverse events
time frame: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
time frame: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
measure: Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score
time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
description: HAQ will include 2 scales: (a) scale for evaluating disability (score range, 0 [without any difficulty] to 3 [unable to do]) and (b) Visual Analogue Scale for evaluating discomfort and pain (score range, 0 [no pain] to 100 [severe pain]).
arm group label: Golimumab
description: Patients will be taking golimumab as per the dosing regimen given on product insert approved in Philippines.
intervention type: Drug
intervention name: No intervention
description: This is an observational study. Golimumab will be administered as per the recommended doses. Golimumab 50 mg will be given as a subcutaneous injection once a month, on the same date each month. For rheumatoid arthritis: Golimumab 2 mg/kg will be given as a 30 minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter.
arm group label: Golimumab
other name: SIMPONI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Pharmaceutica Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Arthritis, Psoriatic
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Golimumab