<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/NCT02196701</url>
  </required_header>
  <id_info>
    <org_study_id>W14-406</org_study_id>
    <nct_id>NCT02196701</nct_id>
  </id_info>
  <brief_title>Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study</brief_title>
  <acronym>CLEAR</acronym>
  <official_title>Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of the use of the&#xD;
      combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in&#xD;
      suboptimal responders to ADA monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2014</start_date>
  <completion_date type="Actual">March 17, 2017</completion_date>
  <primary_completion_date type="Actual">March 17, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment</measure>
    <time_frame>Week 16</time_frame>
    <description>Study investigators were asked to complete the following questionnaire at week 16:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment</measure>
    <time_frame>Week 16</time_frame>
    <description>Participants were asked to complete the following questionnaire at week 16:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time</measure>
    <time_frame>Baseline, week 8 and week 24</time_frame>
    <description>Study investigators were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time</measure>
    <time_frame>Baseline, week 8 and week 24</time_frame>
    <description>Participants were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time</measure>
    <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
    <description>Study investigators were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time</measure>
    <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
    <description>Participants were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time</measure>
    <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PASI 75 Response Over Time</measure>
    <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PASI 90 Response Over Time</measure>
    <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PASI 100 Response Over Time</measure>
    <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PASI Score Over Time</measure>
    <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in PASI Score</measure>
    <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time</measure>
    <time_frame>Weeks 8, 16, and 24</time_frame>
    <description>The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:&#xD;
0 (Cleared): No evidence of scaling, erythema, or plaque elevation;&#xD;
1 (Minimal): Occasional fine scale over &lt;5% of lesions, faint erythema, minimal plaque elevation;&#xD;
2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;&#xD;
3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;&#xD;
4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;&#xD;
5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.&#xD;
The percentage of participants achieving a score of clear (0) or minimal (1) is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis</measure>
    <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
    <description>The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.&#xD;
A decrease in BSA affected by psoriasis indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis</measure>
    <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
    <description>The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.&#xD;
A decrease in BSA affected by psoriasis indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time</measure>
    <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
    <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time</measure>
    <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
    <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time</measure>
    <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
    <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24</measure>
    <time_frame>Baseline and week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Adalimumab Plus Methotrexate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>Administered by subcutaneous injection every other week.</description>
    <arm_group_label>Adalimumab Plus Methotrexate</arm_group_label>
    <other_name>Humira</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Methotrexate was provided as 2.5 mg tablets for oral administration.</description>
    <arm_group_label>Adalimumab Plus Methotrexate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have been on ADA monotherapy (40 mg eow or greater) for at least 16 weeks&#xD;
             but who in the opinion of the Investigator have shown a sub-optimal response to&#xD;
             treatment and have a Physician's Global Assessment (PGA) of ≥ 3 and a Psoriasis Area&#xD;
             Severity Index (PASI) of ≥ 5; or Subjects who after an initial positive response to&#xD;
             ADA monotherapy (40 mg eow or greater) have failed to maintain an optimal level of&#xD;
             response, based on the opinion of the Investigator, and have a PGA of ≥ 3 and a PASI&#xD;
             of ≥ 5;&#xD;
&#xD;
          2. Subjects who are receiving 40 mg ADA once weekly must be on ADA 40 mg eow for 8 weeks&#xD;
             prior to screening;&#xD;
&#xD;
          3. Subjects with at least a 6 month history of chronic plaque psoriasis;&#xD;
&#xD;
          4. Subjects greater than or equal to 18 years of age;&#xD;
&#xD;
          5. If female, subject is either not of childbearing potential, defined as postmenopausal&#xD;
             for at least 1 year or surgically sterile or is of childbearing potential and is&#xD;
             practicing birth control;&#xD;
&#xD;
          6. The results of the serum pregnancy test performed during the Screening Period and&#xD;
             urine pregnancy test performed at the Baseline Visit must be negative;&#xD;
&#xD;
          7. Subject is judged to be in good general health as determined by the Principal&#xD;
             Investigator;&#xD;
&#xD;
          8. Subjects must be evaluated for latent tuberculosis (TB) infection;&#xD;
&#xD;
          9. Subjects must be able and willing to provide written informed consent and comply with&#xD;
             the requirements of the study protocol;&#xD;
&#xD;
         10. Subjects must be willing and able to self-administer subcutaneous (SC) injections or&#xD;
             have a qualified person available to administer SC injections.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any contraindications to MTX or ADA;&#xD;
&#xD;
          2. Subject has a previous failed response or poor tolerance to ADA;&#xD;
&#xD;
          3. Subject has a poorly controlled medical condition which, in the opinion of the&#xD;
             Investigator, would put the subject at risk by participation in the study;&#xD;
&#xD;
          4. Subject has a history of clinically significant hematologic, renal or liver disease;&#xD;
&#xD;
          5. Subject has a history of neurologic symptoms suggestive of central nervous system&#xD;
             (CNS) demyelinating disease and/or diagnosis of central demyelinating disease;&#xD;
&#xD;
          6. Subject has evidence of dysplasia or history of malignancy (including lymphoma and&#xD;
             leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or&#xD;
             basal cell carcinoma or localized carcinoma in situ of the cervix;&#xD;
&#xD;
          7. Subject has a history of listeriosis, histoplasmosis, untreated TB, persistent chronic&#xD;
             infections, or recent active infections requiring hospitalization or treatment with&#xD;
             intravenous (iv) anti-infectives within 30 days or oral anti-infectives within 14 days&#xD;
             prior to the Baseline visit;&#xD;
&#xD;
          8. Subject is known to have immune deficiency, history of human immunodeficiency virus&#xD;
             (HIV) or is immunocompromised;&#xD;
&#xD;
          9. Subject currently uses or plans to use anti-retroviral therapy at any time during the&#xD;
             study;&#xD;
&#xD;
         10. Female subject who is pregnant or breast-feeding or considering becoming pregnant&#xD;
             during the study or for 150 days after the last dose of study medication;&#xD;
&#xD;
         11. Subject has a history of clinically significant drug or alcohol usage in the last year&#xD;
             or cannot maintain an alcohol intake of 30 g a day or less throughout the study (one&#xD;
             standard drink is defined as 180 mL/6 oz (approx. 10 g) of wine, 360 mL/12 oz (approx.&#xD;
             15 g) of regular beer, or 45 mL/1.5 oz (approx. 10 g) of spirits;&#xD;
&#xD;
         12. Screening clinical laboratory analyses show any of the following abnormal laboratory&#xD;
             results:&#xD;
&#xD;
               -  Aspartate transaminase (AST) or alanine transaminase (ALT) &gt; 2x the upper limit&#xD;
                  of normal (ULN);&#xD;
&#xD;
               -  Serum total bilirubin &gt; 1.5 mg/dL (&gt; 26 micromol/L), except for subjects with&#xD;
                  Gilbert's Syndrome;&#xD;
&#xD;
               -  Creatinine &gt; 1.5 mg/dL (133 micromol/L) in subjects ≤ 65 years old and &gt; upper&#xD;
                  limit of normal range in subjects &gt; 65;&#xD;
&#xD;
               -  Positive Hepatitis B or C serology indicative of previous or current infection.&#xD;
&#xD;
         13. Subject is considered by the Investigator, for any reason, to be an unsuitable&#xD;
             candidate for the study;&#xD;
&#xD;
         14. The following treatments are prohibited for all subjects during the study:&#xD;
&#xD;
               -  Phototherapy (ultraviolet A with psoralen [PUVA] within 4 weeks of the Baseline&#xD;
                  Visit and/or ultraviolet B (UVB) within 2 weeks of the Baseline Visit);&#xD;
&#xD;
               -  Other biologic therapies (including any other anti-tumor necrosis factor [TNF])&#xD;
                  within 4 weeks of the Baseline Visit;&#xD;
&#xD;
               -  Any investigational agents of chemical or biologic nature within a minimum of 30&#xD;
                  days or 5 half-lives (whichever is longer) of the drug prior to the Baseline&#xD;
                  visit ;&#xD;
&#xD;
               -  Any other systemic drug therapies for psoriasis within 4 weeks of the Baseline&#xD;
                  Visit;&#xD;
&#xD;
               -  Oral or injectable corticosteroids, new prescription topical therapies, or&#xD;
                  changes in the concentration of current prescription topical therapies (including&#xD;
                  corticosteroids) that are being used, within 2 weeks of the Baseline Visit.&#xD;
                  Subjects may continue using previously prescribed topical therapies (including&#xD;
                  corticosteroids) during the study.&#xD;
&#xD;
         15. Prior exposure to biologics that have a potential or known association with&#xD;
             progressive multifocal leukoencephalopathy (PML), i.e., natalizumab (Tysabri®) or&#xD;
             rituximab (Rituxan®);&#xD;
&#xD;
         16. Subjects with any active viral infection that based on the investigator's clinical&#xD;
             assessment makes the subject an unsuitable candidate for the study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc-André Raymond, PhD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <link>
    <url>http://rxabbvie.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>February 16, 2018</results_first_submitted>
  <results_first_submitted_qc>February 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2018</results_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>methotrexate</keyword>
  <keyword>adalimumab</keyword>
  <keyword>biologic</keyword>
  <keyword>psoriasis</keyword>
  <keyword>Tumor necrosis factor (TNF)-α inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02196701/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02196701/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This single-arm, open-label longitudinal study was conducted at 12 sites in Canada from 5 August 2014 to 17 March 2017. The study entailed a screening period up to 35 days, a 24-week treatment period, and a 70-day safety follow-up period. Participants continued to receive adalimumab (ADA) and had oral methotrexate (MTX) added to their treatment.</recruitment_details>
      <pre_assignment_details>This study enrolled participants who in the opinion of the Investigator were not responding optimally to adalimumab monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) or who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adalimumab + Methotrexate</title>
          <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-adherence to Protocol</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Primary Sub-optimal Responders - ADA + MTX</title>
          <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Secondary Sub-optimal Responders - ADA + MTX</title>
          <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="46"/>
          </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="41.0" spread="13.84"/>
                    <measurement group_id="B2" value="47.3" spread="11.91"/>
                    <measurement group_id="B3" value="46.5" spread="12.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 40 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40 - 64 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Psoriasis</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.623" spread="10.4819"/>
                    <measurement group_id="B2" value="21.760" spread="9.7403"/>
                    <measurement group_id="B3" value="21.612" spread="9.7253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment</title>
        <description>Study investigators were asked to complete the following questionnaire at week 16:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
        <time_frame>Week 16</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment</title>
          <description>Study investigators were asked to complete the following questionnaire at week 16:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="0.0" upper_limit="71.1"/>
                    <measurement group_id="O2" value="52.5" lower_limit="37.0" upper_limit="68.0"/>
                    <measurement group_id="O3" value="50.0" lower_limit="35.6" upper_limit="64.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment</title>
        <description>Participants were asked to complete the following questionnaire at week 16:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
        <time_frame>Week 16</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment</title>
          <description>Participants were asked to complete the following questionnaire at week 16:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="52.5" lower_limit="37.0" upper_limit="68.0"/>
                    <measurement group_id="O3" value="47.8" lower_limit="33.4" upper_limit="62.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time</title>
        <description>Study investigators were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
        <time_frame>Baseline, week 8 and week 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time</title>
          <description>Study investigators were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="10.0" upper_limit="90.0"/>
                    <measurement group_id="O2" value="42.5" lower_limit="27.2" upper_limit="57.8"/>
                    <measurement group_id="O3" value="43.5" lower_limit="29.2" upper_limit="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="0.0" upper_limit="71.1"/>
                    <measurement group_id="O2" value="60.0" lower_limit="44.8" upper_limit="75.2"/>
                    <measurement group_id="O3" value="56.5" lower_limit="42.2" upper_limit="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time</title>
        <description>Participants were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
        <time_frame>Baseline, week 8 and week 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time</title>
          <description>Participants were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied&#xD;
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="17.5" lower_limit="5.7" upper_limit="29.3"/>
                    <measurement group_id="O3" value="15.2" lower_limit="4.8" upper_limit="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="52.5" lower_limit="37.0" upper_limit="68.0"/>
                    <measurement group_id="O3" value="47.8" lower_limit="33.4" upper_limit="62.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="60.0" lower_limit="44.8" upper_limit="75.2"/>
                    <measurement group_id="O3" value="54.3" lower_limit="40.0" upper_limit="68.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time</title>
        <description>Study investigators were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied</description>
        <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time</title>
          <description>Study investigators were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX with available data at each time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time</title>
        <description>Participants were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied</description>
        <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX and with available data at each time point..</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time</title>
          <description>Participants were asked to complete the following questionnaire at each scheduled visit:&#xD;
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:&#xD;
Completely dissatisfied&#xD;
Moderately dissatisfied&#xD;
Slightly satisfied&#xD;
Highly satisfied&#xD;
Completely satisfied</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX and with available data at each time point..</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <title>Completely satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.</description>
        <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="10.0" upper_limit="90.0"/>
                    <measurement group_id="O2" value="42.5" lower_limit="27.2" upper_limit="57.8"/>
                    <measurement group_id="O3" value="43.5" lower_limit="29.2" upper_limit="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="10.0" upper_limit="90.0"/>
                    <measurement group_id="O2" value="62.5" lower_limit="47.5" upper_limit="77.5"/>
                    <measurement group_id="O3" value="60.9" lower_limit="46.8" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="28.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="65.0" lower_limit="50.2" upper_limit="79.8"/>
                    <measurement group_id="O3" value="65.2" lower_limit="51.5" upper_limit="79.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PASI 75 Response Over Time</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.</description>
        <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PASI 75 Response Over Time</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="0.0" upper_limit="71.1"/>
                    <measurement group_id="O2" value="27.5" lower_limit="13.7" upper_limit="41.3"/>
                    <measurement group_id="O3" value="28.3" lower_limit="15.2" upper_limit="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="42.5" lower_limit="27.2" upper_limit="57.8"/>
                    <measurement group_id="O3" value="39.1" lower_limit="25.0" upper_limit="53.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="42.5" lower_limit="27.2" upper_limit="57.8"/>
                    <measurement group_id="O3" value="39.1" lower_limit="25.0" upper_limit="53.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PASI 90 Response Over Time</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.</description>
        <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PASI 90 Response Over Time</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="12.5" lower_limit="2.3" upper_limit="22.7"/>
                    <measurement group_id="O3" value="13.0" lower_limit="3.3" upper_limit="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="15.0" lower_limit="3.9" upper_limit="26.1"/>
                    <measurement group_id="O3" value="15.2" lower_limit="4.8" upper_limit="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="30.0" lower_limit="15.8" upper_limit="44.2"/>
                    <measurement group_id="O3" value="28.3" lower_limit="15.2" upper_limit="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PASI 100 Response Over Time</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.</description>
        <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PASI 100 Response Over Time</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="12.5" lower_limit="2.3" upper_limit="22.7"/>
                    <measurement group_id="O3" value="13.0" lower_limit="3.3" upper_limit="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="10.0" lower_limit="0.7" upper_limit="19.3"/>
                    <measurement group_id="O3" value="10.9" lower_limit="1.9" upper_limit="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="27.5" lower_limit="13.7" upper_limit="41.3"/>
                    <measurement group_id="O3" value="26.1" lower_limit="13.4" upper_limit="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PASI Score Over Time</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).</description>
        <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PASI Score Over Time</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.6" spread="2.07"/>
                    <measurement group_id="O2" value="-4.6" spread="0.65"/>
                    <measurement group_id="O3" value="-4.6" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="1.31"/>
                    <measurement group_id="O2" value="-6.2" spread="0.59"/>
                    <measurement group_id="O3" value="-5.9" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="3.17"/>
                    <measurement group_id="O2" value="-6.3" spread="0.68"/>
                    <measurement group_id="O3" value="-5.9" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in PASI Score</title>
        <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).</description>
        <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in PASI Score</title>
          <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.6" spread="16.23"/>
                    <measurement group_id="O2" value="-43.7" spread="6.11"/>
                    <measurement group_id="O3" value="-44.8" spread="5.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-45.6" spread="15.15"/>
                    <measurement group_id="O2" value="-59.2" spread="5.06"/>
                    <measurement group_id="O3" value="-57.3" spread="4.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.4" spread="45.65"/>
                    <measurement group_id="O2" value="-63.7" spread="5.78"/>
                    <measurement group_id="O3" value="-58.1" spread="8.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time</title>
        <description>The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:&#xD;
0 (Cleared): No evidence of scaling, erythema, or plaque elevation;&#xD;
1 (Minimal): Occasional fine scale over &lt;5% of lesions, faint erythema, minimal plaque elevation;&#xD;
2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;&#xD;
3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;&#xD;
4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;&#xD;
5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.&#xD;
The percentage of participants achieving a score of clear (0) or minimal (1) is reported.</description>
        <time_frame>Weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time</title>
          <description>The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:&#xD;
0 (Cleared): No evidence of scaling, erythema, or plaque elevation;&#xD;
1 (Minimal): Occasional fine scale over &lt;5% of lesions, faint erythema, minimal plaque elevation;&#xD;
2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;&#xD;
3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;&#xD;
4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;&#xD;
5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.&#xD;
The percentage of participants achieving a score of clear (0) or minimal (1) is reported.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="27.5" lower_limit="13.7" upper_limit="41.3"/>
                    <measurement group_id="O3" value="26.1" lower_limit="13.4" upper_limit="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="35.0" lower_limit="20.2" upper_limit="49.8"/>
                    <measurement group_id="O3" value="32.6" lower_limit="19.1" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="47.5" lower_limit="32.0" upper_limit="63.0"/>
                    <measurement group_id="O3" value="43.5" lower_limit="29.2" upper_limit="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis</title>
        <description>The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.&#xD;
A decrease in BSA affected by psoriasis indicates improvement.</description>
        <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis</title>
          <description>The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.&#xD;
A decrease in BSA affected by psoriasis indicates improvement.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
          <units>percentage of body surface area</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="2.95"/>
                    <measurement group_id="O2" value="-4.5" spread="1.06"/>
                    <measurement group_id="O3" value="-4.4" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="2.40"/>
                    <measurement group_id="O2" value="-6.4" spread="1.08"/>
                    <measurement group_id="O3" value="-6.2" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="1.57"/>
                    <measurement group_id="O2" value="-6.3" spread="0.89"/>
                    <measurement group_id="O3" value="-6.0" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis</title>
        <description>The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.&#xD;
A decrease in BSA affected by psoriasis indicates improvement.</description>
        <time_frame>Baseline and weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis</title>
          <description>The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.&#xD;
A decrease in BSA affected by psoriasis indicates improvement.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.9" spread="23.10"/>
                    <measurement group_id="O2" value="-34.1" spread="7.48"/>
                    <measurement group_id="O3" value="-33.4" spread="7.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.1" spread="22.25"/>
                    <measurement group_id="O2" value="-54.2" spread="5.89"/>
                    <measurement group_id="O3" value="-51.4" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.7" spread="22.25"/>
                    <measurement group_id="O2" value="-61.7" spread="6.33"/>
                    <measurement group_id="O3" value="-57.8" spread="6.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time</title>
        <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time</title>
          <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="1.40"/>
                    <measurement group_id="O2" value="-4.8" spread="0.71"/>
                    <measurement group_id="O3" value="-4.8" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="2.54"/>
                    <measurement group_id="O2" value="-5.9" spread="0.78"/>
                    <measurement group_id="O3" value="-5.6" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="4.29"/>
                    <measurement group_id="O2" value="-6.3" spread="0.69"/>
                    <measurement group_id="O3" value="-5.4" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time</title>
        <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline, weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time</title>
          <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.0" spread="21.50"/>
                    <measurement group_id="O2" value="-38.6" spread="7.01"/>
                    <measurement group_id="O3" value="-39.2" spread="6.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.9" spread="40.40"/>
                    <measurement group_id="O2" value="-38.9" spread="12.79"/>
                    <measurement group_id="O3" value="-36.7" spread="11.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="71.98"/>
                    <measurement group_id="O2" value="-55.0" spread="6.90"/>
                    <measurement group_id="O3" value="-44.5" spread="11.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time</title>
        <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.</description>
        <time_frame>Baseline and Weeks 8, 16, and 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time</title>
          <description>The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.</description>
          <population>Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="20.0" lower_limit="7.6" upper_limit="32.4"/>
                    <measurement group_id="O3" value="19.6" lower_limit="8.1" upper_limit="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="40.0" lower_limit="24.8" upper_limit="55.2"/>
                    <measurement group_id="O3" value="37.0" lower_limit="23.0" upper_limit="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.0" upper_limit="46.5"/>
                    <measurement group_id="O2" value="40.0" lower_limit="24.8" upper_limit="55.2"/>
                    <measurement group_id="O3" value="37.0" lower_limit="23.0" upper_limit="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24</title>
        <time_frame>Baseline and week 24</time_frame>
        <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Sub-optimal Responders - ADA + MTX</title>
            <description>Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab + Methotrexate</title>
            <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24</title>
          <population>Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.</population>
          <units>mg/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="0.47"/>
                    <measurement group_id="O2" value="0.1" spread="1.52"/>
                    <measurement group_id="O3" value="-0.3" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Adalimumab + Methotrexate</title>
          <description>Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MEDDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MEDDRA 19.1</default_vocab>
        <default_assessment>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="27" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Beta haemolytic streptococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Psoriatic arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Crystalluria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT02196701
org study id: W14-406
nct id: NCT02196701
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety and efficacy of the use of the
      combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in
      suboptimal responders to ADA monotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment
time frame: Week 16
description: Study investigators were asked to complete the following questionnaire at week 16:
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
Completely dissatisfied
Moderately dissatisfied
Slightly satisfied
Highly satisfied
Completely satisfied
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.
measure: Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment
time frame: Week 16
description: Participants were asked to complete the following questionnaire at week 16:
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
Completely dissatisfied
Moderately dissatisfied
Slightly satisfied
Highly satisfied
Completely satisfied
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.
measure: Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time
time frame: Baseline, week 8 and week 24
description: Study investigators were asked to complete the following questionnaire at each scheduled visit:
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
Completely dissatisfied
Moderately dissatisfied
Slightly satisfied
Highly satisfied
Completely satisfied
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.
measure: Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time
time frame: Baseline, week 8 and week 24
description: Participants were asked to complete the following questionnaire at each scheduled visit:
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
Completely dissatisfied
Moderately dissatisfied
Slightly satisfied
Highly satisfied
Completely satisfied
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.
measure: Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time
time frame: Baseline, weeks 8, 16, and 24
description: Study investigators were asked to complete the following questionnaire at each scheduled visit:
Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
Completely dissatisfied
Moderately dissatisfied
Slightly satisfied
Highly satisfied
Completely satisfied
measure: Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time
time frame: Baseline, weeks 8, 16, and 24
description: Participants were asked to complete the following questionnaire at each scheduled visit:
Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
Completely dissatisfied
Moderately dissatisfied
Slightly satisfied
Highly satisfied
Completely satisfied
measure: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time
time frame: Baseline and Weeks 8, 16, and 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.
measure: Percentage of Participants Who Achieved a PASI 75 Response Over Time
time frame: Baseline and Weeks 8, 16, and 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.
measure: Percentage of Participants Who Achieved a PASI 90 Response Over Time
time frame: Baseline and Weeks 8, 16, and 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.
measure: Percentage of Participants Who Achieved a PASI 100 Response Over Time
time frame: Baseline and Weeks 8, 16, and 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.
measure: Change From Baseline in PASI Score Over Time
time frame: Baseline and weeks 8, 16, and 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
measure: Percent Change From Baseline in PASI Score
time frame: Baseline and weeks 8, 16, and 24
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
measure: Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time
time frame: Weeks 8, 16, and 24
description: The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:
0 (Cleared): No evidence of scaling, erythema, or plaque elevation;
1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;
2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;
3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;
4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;
5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.
The percentage of participants achieving a score of clear (0) or minimal (1) is reported.
measure: Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis
time frame: Baseline and weeks 8, 16, and 24
description: The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.
A decrease in BSA affected by psoriasis indicates improvement.
measure: Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis
time frame: Baseline and weeks 8, 16, and 24
description: The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.
A decrease in BSA affected by psoriasis indicates improvement.
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
time frame: Baseline, weeks 8, 16, and 24
description: The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.
measure: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
time frame: Baseline, weeks 8, 16, and 24
description: The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.
measure: Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time
time frame: Baseline and Weeks 8, 16, and 24
description: The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
measure: Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24
time frame: Baseline and week 24
arm group label: Adalimumab Plus Methotrexate
arm group type: Experimental
description: Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
intervention type: Drug
intervention name: Adalimumab
description: Administered by subcutaneous injection every other week.
arm group label: Adalimumab Plus Methotrexate
other name: Humira
intervention type: Drug
intervention name: Methotrexate
description: Methotrexate was provided as 2.5 mg tablets for oral administration.
arm group label: Adalimumab Plus Methotrexate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Marc-André Raymond, PhD
role: Study Director
affiliation: AbbVie
country: Canada
url: http://rxabbvie.com/
description: Related Info
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Adalimumab
mesh term: Methotrexate
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 