<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/NCT01691014</url>
  </required_header>
  <id_info>
    <org_study_id>B1801347</org_study_id>
    <nct_id>NCT01691014</nct_id>
  </id_info>
  <brief_title>Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents</brief_title>
  <official_title>Formation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rationale for this study is to further explore if development of antibodies against TNF-α&#xD;
      blocking agents is associated with reduced clinical effect/worsened clinical outcome. An&#xD;
      important aspect of the study is to carry out an exploratory analysis of the immunogenicity&#xD;
      of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using the same&#xD;
      cell-based assay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      no sampling&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated on 10DEC2014 due to the inability to enroll the planned number of&#xD;
    patients. There were no safety concerns.&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</measure>
    <time_frame>Month 6</time_frame>
    <description>Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</measure>
    <time_frame>Month 6</time_frame>
    <description>Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment</measure>
    <time_frame>Month 6, 12</time_frame>
    <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment</measure>
    <time_frame>Month 6, 12</time_frame>
    <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits</measure>
    <time_frame>Month 6, 12</time_frame>
    <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</measure>
    <time_frame>Month 3, 12</time_frame>
    <description>Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment</measure>
    <time_frame>Month 12</time_frame>
    <description>Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12</measure>
    <time_frame>Month 3, 6, 12</time_frame>
    <description>DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (&lt;=) 3.2 implied low disease activity and greater than (&gt;) 3.2 to 5.1 implied moderate to high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12</measure>
    <time_frame>Baseline, Month 3, 6, 12</time_frame>
    <description>HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Rheumatoid Arthritis (RA)</condition>
  <arm_group>
    <arm_group_label>adalimumab</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Etanercept</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>infliximab</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Certolizumab</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-interventional study</intervention_name>
    <description>Study with 4 arms/groups with 36 patients per group. In total 144 patients.</description>
    <arm_group_label>adalimumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-interventional study</intervention_name>
    <description>Study with 4 arms/groups with 36 patients per group. In total 144 patients.</description>
    <arm_group_label>Etanercept</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-interventional study</intervention_name>
    <description>Study with 4 arms/groups with 36 patients per group. In total 144 patients.</description>
    <arm_group_label>infliximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-interventional study</intervention_name>
    <description>Study with 4 arms/groups with 36 patients per group. In total 144 patients.</description>
    <arm_group_label>Certolizumab</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with Rheumatoid Arthritis (RA)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject fulfils criteria for Rheumatoid Arthritis (RA) according to ACR or EULAR&#xD;
             criteria.&#xD;
&#xD;
          -  Subjects who are planned to start treatment with ADA, ETA, CER or IFX&#xD;
&#xD;
          -  Subjects taking a minimum weekly dose of 7.5 mg of methotrexate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with compliance problems&#xD;
&#xD;
          -  Patients who have difficulties in reading and understanding local language&#xD;
&#xD;
          -  Patients with Juvenile Idiopathic Arthritis (JIA)&#xD;
&#xD;
          -  Azathioprine or cyclophosphamide treatment within 6 months before entering into the&#xD;
             study&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aalborg Universitetshospital Nord/Reumatologisk Afdelning</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital/Reumatologisk Afdelning U</name>
      <address>
        <city>Aarhus C.</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydvestjysk Sygehus / Reumatologisk Afdeling</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederiksberg Hospital / Reumatologisk Afdeling</name>
      <address>
        <city>Frederiksberg</city>
        <zip>2000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gentofte Hospital, Medicinsk afd. C</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillerod Hospital/Reumatologisk Afdeling</name>
      <address>
        <city>Hillerod</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holbaek Sygehus</name>
      <address>
        <city>Holbaek</city>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reumatologisk afd</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitets Hospital/Reumatologisk Afdeling C</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regionshospitalet Randers / Reumatologisk Klinik</name>
      <address>
        <city>Randers NØ</city>
        <zip>8930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Svendborg Sygehus / Medicinsk Afdeling M</name>
      <address>
        <city>Svendborg</city>
        <zip>5700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus / Medicinsk Afdeling</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospitalsenheden Viborg Reumatologisk Ambulatorium</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801347&amp;StudyName=Formation%20of%20Antibodies%20and%20Subsequent%20Prediction%20of%20Clinical%20Response%20in%20Patients%20with%20Rheumatoid%20Arthritis%20Treated%20with%20four%20TNF%20Blockin</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>November 1, 2016</results_first_submitted>
  <results_first_submitted_qc>November 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 29, 2016</results_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Adalimumab</title>
          <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="P2">
          <title>Etanercept</title>
          <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="P3">
          <title>Certolizumab</title>
          <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="P4">
          <title>Infliximab</title>
          <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="36"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Premature Termination</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Effectiveness analysis set (EAS) included all participants that provided at least 1 post-baseline assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Adalimumab</title>
          <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="B2">
          <title>Etanercept</title>
          <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="B3">
          <title>Certolizumab</title>
          <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="B4">
          <title>Infliximab</title>
          <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="B5">
          <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="8"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="36"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="79"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="51" spread="6"/>
                    <measurement group_id="B2" value="57" spread="13"/>
                    <measurement group_id="B3" value="56" spread="14"/>
                    <measurement group_id="B4" value="51" spread="11"/>
                    <measurement group_id="B5" value="55" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="4"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</title>
        <description>Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
        <time_frame>Month 6</time_frame>
        <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</title>
          <description>Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
          <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</title>
        <description>Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
        <time_frame>Month 6</time_frame>
        <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</title>
          <description>Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
          <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment</title>
        <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.</description>
        <time_frame>Month 6, 12</time_frame>
        <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment</title>
          <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.</description>
          <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment</title>
        <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.</description>
        <time_frame>Month 6, 12</time_frame>
        <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment</title>
          <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.</description>
          <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits</title>
        <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.</description>
        <time_frame>Month 6, 12</time_frame>
        <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits</title>
          <description>Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.</description>
          <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</title>
        <description>Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
        <time_frame>Month 3, 12</time_frame>
        <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab</title>
          <description>Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.</description>
          <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment</title>
        <description>Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.</description>
        <time_frame>Month 12</time_frame>
        <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment</title>
          <description>Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.</description>
          <population>Data was not collected since this outcome measure was not analyzed due to premature termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12</title>
        <description>DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (&lt;=) 3.2 implied low disease activity and greater than (&gt;) 3.2 to 5.1 implied moderate to high disease activity.</description>
        <time_frame>Month 3, 6, 12</time_frame>
        <population>EAS included all participants that provided at least 1 post-baseline assessment. Here,&quot;n&quot; signifies number of participants evaluable at the specified time points for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12</title>
          <description>DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (&lt;=) 3.2 implied low disease activity and greater than (&gt;) 3.2 to 5.1 implied moderate to high disease activity.</description>
          <population>EAS included all participants that provided at least 1 post-baseline assessment. Here,&quot;n&quot; signifies number of participants evaluable at the specified time points 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="8"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n= 7, 23, 34, 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="1.0"/>
                    <measurement group_id="O2" value="3.0" spread="1.1"/>
                    <measurement group_id="O3" value="3.0" spread="1.4"/>
                    <measurement group_id="O4" value="3.0" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n= 6, 18, 26, 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.6"/>
                    <measurement group_id="O2" value="2.2" spread="1.1"/>
                    <measurement group_id="O3" value="2.4" spread="1.3"/>
                    <measurement group_id="O4" value="1.8" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n= 5, 11, 25, 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.8"/>
                    <measurement group_id="O2" value="2.4" spread="0.8"/>
                    <measurement group_id="O3" value="2.5" spread="1.1"/>
                    <measurement group_id="O4" value="2.7" spread="0.6"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.990</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.586</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.980</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12</title>
        <description>HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.</description>
        <time_frame>Baseline, Month 3, 6, 12</time_frame>
        <population>EAS included all participants that provided at least 1 post-baseline assessment. Here, &quot;n&quot; signifies number of participants evaluable for this outcome measure at the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept</title>
            <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Certolizumab</title>
            <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Infliximab</title>
            <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12</title>
          <description>HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.</description>
          <population>EAS included all participants that provided at least 1 post-baseline assessment. Here, &quot;n&quot; signifies number of participants evaluable for this outcome measure at the specified time points.</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="8"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 8, 26, 36, 9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.6"/>
                    <measurement group_id="O2" value="1.2" spread="0.6"/>
                    <measurement group_id="O3" value="1.2" spread="0.7"/>
                    <measurement group_id="O4" value="1.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n= 7, 23, 34, 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.6"/>
                    <measurement group_id="O2" value="0.9" spread="0.7"/>
                    <measurement group_id="O3" value="0.8" spread="0.7"/>
                    <measurement group_id="O4" value="1.2" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n= 6, 18, 26, 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                    <measurement group_id="O2" value="0.6" spread="0.6"/>
                    <measurement group_id="O3" value="0.7" spread="0.6"/>
                    <measurement group_id="O4" value="0.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n= 5, 11, 25, 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.4"/>
                    <measurement group_id="O2" value="1.0" spread="0.8"/>
                    <measurement group_id="O3" value="0.6" spread="0.6"/>
                    <measurement group_id="O4" value="0.8" spread="0.7"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.945</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.458</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.896</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.390</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline upto 12 months</time_frame>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participants may have experienced both a serious and non-serious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Adalimumab</title>
          <description>Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="E2">
          <title>Etanercept</title>
          <description>Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="E3">
          <title>Certolizumab</title>
          <description>Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
        <group group_id="E4">
          <title>Infliximab</title>
          <description>Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</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="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of esophagus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Periumbilical pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling unwell</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Therapeutic product ineffective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Foreign body reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Allergy NOS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Infection localised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nose infection NOS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Cold sores lip</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Flu symptoms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Elevated liver enzymes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Eczema aggravated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Palmoplantar pustulosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Drug rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypertension arterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis leg</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to premature termination of the study, the primary objective and few of the secondary objectives for the study were not met.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Pfizer Inc.</name_or_title>
      <organization>Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc.</organization>
      <phone>001 800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT01691014
org study id: B1801347
nct id: NCT01691014
lead sponsor: 
has dmc: No
The rationale for this study is to further explore if development of antibodies against TNF-α
      blocking agents is associated with reduced clinical effect/worsened clinical outcome. An
      important aspect of the study is to carry out an exploratory analysis of the immunogenicity
      of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using the same
      cell-based assay.
no sampling
observational model: Cohort
time perspective: Prospective
measure: Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
time frame: Month 6
description: Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
measure: Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
time frame: Month 6
description: Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
measure: Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment
time frame: Month 6, 12
description: Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.
measure: Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment
time frame: Month 6, 12
description: Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
measure: Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits
time frame: Month 6, 12
description: Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.
measure: Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
time frame: Month 3, 12
description: Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
measure: Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment
time frame: Month 12
description: Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.
measure: Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12
time frame: Month 3, 6, 12
description: DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity.
measure: Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
time frame: Baseline, Month 3, 6, 12
description: HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
arm group label: adalimumab
arm group label: Etanercept
arm group label: infliximab
arm group label: Certolizumab
intervention type: Other
intervention name: non-interventional study
description: Study with 4 arms/groups with 36 patients per group. In total 144 patients.
arm group label: adalimumab
intervention type: Other
intervention name: non-interventional study
description: Study with 4 arms/groups with 36 patients per group. In total 144 patients.
arm group label: Etanercept
intervention type: Other
intervention name: non-interventional study
description: Study with 4 arms/groups with 36 patients per group. In total 144 patients.
arm group label: infliximab
intervention type: Other
intervention name: non-interventional study
description: Study with 4 arms/groups with 36 patients per group. In total 144 patients.
arm group label: Certolizumab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
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country: Denmark
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801347&StudyName=Formation%20of%20Antibodies%20and%20Subsequent%20Prediction%20of%20Clinical%20Response%20in%20Patients%20with%20Rheumatoid%20Arthritis%20Treated%20with%20four%20TNF%20Blockin
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to premature termination of the study, the primary objective and few of the secondary objectives for the study were not met.
point of contact: 