<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/NCT01690299</url>
  </required_header>
  <id_info>
    <org_study_id>CC-10004-PSOR-010</org_study_id>
    <secondary_id>2012-000859-14</secondary_id>
    <nct_id>NCT01690299</nct_id>
  </id_info>
  <brief_title>Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis</brief_title>
  <official_title>A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the clinical effectiveness and safety of apremilast compared with&#xD;
      placebo as well as etanercept compared with placebo in the same group of patients with&#xD;
      moderate to severe plaque psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy,&#xD;
      study of the efficacy and safety of apremilast, etanercept, and placebo, in adults with&#xD;
      moderate to severe plaque psoriasis.&#xD;
&#xD;
      250 participants will be randomized 1:1:1 to the three treatment groups. All subjects will&#xD;
      receive both tablets and injections through Week 16.&#xD;
&#xD;
      The study will consist of four phases:&#xD;
&#xD;
        -  Screening Phase - up to 35 days&#xD;
&#xD;
        -  Double-blind Placebo-controlled Phase - Weeks 0-16&#xD;
&#xD;
        -  Apremilast Extension Phase - Weeks 16-104&#xD;
&#xD;
        -  Post-treatment Observational Follow-up Phase&#xD;
&#xD;
      During the double-blind, placebo-controlled phase, subjects will receive treatment with one&#xD;
      of the following:&#xD;
&#xD;
        -  apremilast (APR) 30 mg tablets orally twice a day (BID) plus once weekly (QW)&#xD;
           evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections (1 mL x 2&#xD;
           injections SC), or&#xD;
&#xD;
        -  etanercept (ETN) 50 mg evaluator/subject-blinded subcutaneous (SC) once weekly (QW)&#xD;
           injections (2 x 25 mg) plus placebo tablets orally twice a day (BID), or&#xD;
&#xD;
        -  placebo tablets and evaluator/subject-blinded subcutaneous (SC) saline (placebo)&#xD;
           injections.&#xD;
&#xD;
      All subjects will be asked to participate in a 4-week Post-treatment Observational Follow-up&#xD;
      Phase either upon completion of the study or upon discontinuation of investigational product&#xD;
      for those subjects who terminate the study early.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">April 4, 2016</completion_date>
  <primary_completion_date type="Actual">July 3, 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot; including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from &quot;Very Much&quot; (score 3) to &quot;Not at All&quot; or &quot;Not relevant&quot; (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if &quot;No,&quot; then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being &quot;A lot,&quot; &quot;A little,&quot; or &quot;Not at all&quot; (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase</measure>
    <time_frame>Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group</time_frame>
    <description>A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period</measure>
    <time_frame>From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose</time_frame>
    <description>A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Flare/Rebound</measure>
    <time_frame>Week 0 to Week 16; Placebo controlled phase</time_frame>
    <description>Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Flare/Rebound</measure>
    <time_frame>From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.</time_frame>
    <description>Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Psoriasis</condition>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Apremilast 30 mg plus placebo injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etanercept 50 mg plus placebo tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral placebo tablets plus SC placebo injections</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identically matching placebo tablets and evaluator/subject-blinded SC injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apremilast</intervention_name>
    <description>Apremilast 30 mg tablet orally BID</description>
    <arm_group_label>Apremilast 30 mg plus placebo injection</arm_group_label>
    <other_name>CC-10004</other_name>
    <other_name>Otezla</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etanercept</intervention_name>
    <description>Etanercept 50 mg evaluator/subject-blinded SC QW injection</description>
    <arm_group_label>Etanercept 50 mg plus placebo tablet</arm_group_label>
    <other_name>Enbrel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo tablet</intervention_name>
    <description>Placebo tablets BID</description>
    <arm_group_label>Etanercept 50 mg plus placebo tablet</arm_group_label>
    <arm_group_label>Oral placebo tablets plus SC placebo injections</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo injection</intervention_name>
    <description>Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)</description>
    <arm_group_label>Apremilast 30 mg plus placebo injection</arm_group_label>
    <arm_group_label>Oral placebo tablets plus SC placebo injections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females, ≥ 18 years of age&#xD;
&#xD;
          -  Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior&#xD;
             to Screening, and a candidate for phototherapy and/or systemic (including etanercept)&#xD;
             therapy&#xD;
&#xD;
          -  Had an inadequate response, intolerance, or contraindication to at least 1&#xD;
             conventional systemic agent for the treatment of psoriasis.&#xD;
&#xD;
          -  No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other than psoriasis, history of any clinically significant and uncontrolled systemic&#xD;
             diseases; any condition, including the presence of laboratory abnormalities, which&#xD;
             would place the subject at unacceptable risk if he/she were to participate in the&#xD;
             study.&#xD;
&#xD;
          -  Pregnant or breast feeding.&#xD;
&#xD;
          -  Have failed more than 3 systemic agents for treatment of psoriasis.&#xD;
&#xD;
          -  History of allergy to any component of the investigational product (IP), including&#xD;
             human immunoglobulin (Ig) proteins or allergy to etanercept.&#xD;
&#xD;
          -  Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.&#xD;
&#xD;
          -  Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous&#xD;
             mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis&#xD;
             carinii, aspergillosis, Clostridium difficile).&#xD;
&#xD;
          -  Have a history of, or ongoing, chronic or recurrent infectious disease&#xD;
&#xD;
          -  Have received, or are expected to receive, any live virus or bacterial vaccination&#xD;
             within 3 months before first administration of IP, or through Week 20 during the&#xD;
             study.&#xD;
&#xD;
          -  Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.&#xD;
&#xD;
          -  History of positive human immunodeficiency virus (HIV), or have congenital or acquired&#xD;
             immunodeficiency (eg, common variable immunodeficiency disease).&#xD;
&#xD;
          -  Active substance abuse or a history of substance abuse within 6 months prior to&#xD;
             Screening.&#xD;
&#xD;
          -  Malignancy or history of malignancy, except for treated [ie, cured] basal cell or&#xD;
             squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia [CIN] or&#xD;
             carcinoma in situ of the cervix with no evidence of recurrence within the previous 5&#xD;
             years.&#xD;
&#xD;
          -  Psoriasis flare or rebound within 4 weeks prior to Screening.&#xD;
&#xD;
          -  Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis&#xD;
             within 4 weeks prior to randomization&#xD;
&#xD;
          -  Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or&#xD;
             use of tanning booths or other ultraviolet (UV) light sources.&#xD;
&#xD;
          -  Any investigational drug within 4 weeks prior to randomization, or 5&#xD;
             pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).&#xD;
&#xD;
          -  Prior treatment with apremilast or etanercept.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bakersfield Dermatology and Skin Cancer Medical Group</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine-Department of Dermatology</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizons Clinical Research</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Center for Dermatology, PA</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Academic Dermatology Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Dermatology Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renstar Medical Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Dermatology, Vein and Research Center, PC</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dawes Fretzin Clinical Research Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology and Advanced Aesthetics</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence Green, MD, LLC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Wood Johnson Medical School</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forest Hills Dermatology Group</name>
      <address>
        <city>Forest Hills</city>
        <state>New York</state>
        <zip>11375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Department of Dermatology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennesse Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teckton Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Education and Research Foundation</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research Inc</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Associates of Seattle</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Skin Centre</name>
      <address>
        <city>Benowa</city>
        <state>Queensland</state>
        <zip>4217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinclair Dermatology</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fremantle Dermatology</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gairdner Hospital</name>
      <address>
        <city>Victoria Park</city>
        <zip>6100</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology unit Ward 5C Queen Elizabeth Hospital</name>
      <address>
        <city>Woodville</city>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veracity Clinical Research</name>
      <address>
        <city>Woolloongabba</city>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ghent</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Liege CHU Liege</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Canada Cutaneous Research Associates Ltd</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Center for Dermatology</name>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <zip>K9J 5K2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>K. Papp Clinical Research Inc.</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siena Medical Research</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3Z 2S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q &amp; T Research Sherbrooke Inc.</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 4J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dorothea, Kožní a korektivne dermatologické pracovište</name>
      <address>
        <city>Chomutov</city>
        <zip>430 04</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermamedica</name>
      <address>
        <city>Nachod</city>
        <zip>54701</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Východoceské dermatologické centrum Homea s.r.o.</name>
      <address>
        <city>Pardubice</city>
        <zip>530 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krajská nemocnice Pardubice, Kožní oddelení</name>
      <address>
        <city>Pardubice</city>
        <zip>532 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatovenerologicka ambulance</name>
      <address>
        <city>Svitavy</city>
        <zip>568 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koznia zilni ambulance</name>
      <address>
        <city>Ústí nad Labem</city>
        <zip>400 10</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Estonian Hospital Ltd</name>
      <address>
        <city>Meegomäe Village, Võru County</city>
        <zip>65526</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Clinic of Tartu University Hospital</name>
      <address>
        <city>Tartu</city>
        <zip>50417</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psoriasis Study Center</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatologische Praxis</name>
      <address>
        <city>Berlin</city>
        <zip>10827</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Berlin - Buch GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>1307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautklinik Universitatsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCIderm GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center</name>
      <address>
        <city>Hamburg</city>
        <zip>D-20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitatsKlinikum Leipzig A.o.R.</name>
      <address>
        <city>Leipzig</city>
        <zip>4103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Mahlow</name>
      <address>
        <city>Mahlow</city>
        <zip>15831</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Munster</name>
      <address>
        <city>Münster</city>
        <zip>48143</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fr Dermatologie und Venerologie</name>
      <address>
        <city>Wuppertal</city>
        <zip>42275</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tolna Megyei Balassa Janos Korhaz</name>
      <address>
        <city>Szekszárd</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergo-Derm Bakos Kft.</name>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD M &amp; M centrs</name>
      <address>
        <city>Adazi</city>
        <zip>2164</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arija's Ancane's Family Doctor Private Practice</name>
      <address>
        <city>Baldone</city>
        <zip>2125</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre</name>
      <address>
        <city>Riga</city>
        <zip>1001</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adoria Ltd</name>
      <address>
        <city>Riga</city>
        <zip>1011</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Doctor's Indra's Kenina's Practice</name>
      <address>
        <city>Riga</city>
        <zip>1011</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Center of Talsi Ltd</name>
      <address>
        <city>Talsi</city>
        <zip>3201</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS7 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whipps Cross University Hospital</name>
      <address>
        <city>London</city>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Helier Hospital</name>
      <address>
        <city>London</city>
        <zip>SM5 1AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Eliot Hospital</name>
      <address>
        <city>Nuneaton</city>
        <zip>CV10 7DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Latvia</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <reference>
    <citation>Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.</citation>
    <PMID>34255891</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>July 2, 2015</results_first_submitted>
  <results_first_submitted_qc>July 7, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 4, 2015</results_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>arthritis</keyword>
  <keyword>psoriatic</keyword>
  <keyword>palmoplantar</keyword>
  <keyword>scalp</keyword>
  <keyword>psoriasis pill</keyword>
  <keyword>psoriasis tablet</keyword>
  <keyword>plaque psoriasis</keyword>
  <keyword>plaque type psoriasis</keyword>
  <keyword>moderate to severe plaque type psoriasis</keyword>
  <keyword>psoriatic arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
    <mesh_term>Apremilast</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>http://www.amgen.com/datasharing</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 65 study centers in 11 countries.</recruitment_details>
      <pre_assignment_details>Participants were randomized 1:1:1 to the three treatment groups. Participants were stratified according to their calculated body mass index (BMI) categories at Screening (BMI &lt; 30 or BMI ≥ 30).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="P2">
          <title>Apremilast Plus Placebo Injection</title>
          <description>Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="P3">
          <title>Etanercept Plus Placebo Tablet</title>
          <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="P4">
          <title>Placebo/Apremilast</title>
          <description>Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.</description>
        </group>
        <group group_id="P5">
          <title>Apremilast/Apremilast</title>
          <description>Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.</description>
        </group>
        <group group_id="P6">
          <title>Etanercept/Apremilast</title>
          <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Placebo-controlled Phase (Weeks 0-16)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="83"/>
                <participants group_id="P3" count="83"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="84">Safety population includes all participants who received at least one dose of study drug.</participants>
                <participants group_id="P2" count="83">Safety population includes all participants who received at least one dose of study drug.</participants>
                <participants group_id="P3" count="83">Safety population includes all participants who received at least one dose of study drug.</participants>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="77"/>
                <participants group_id="P3" count="81"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Apremilast Extension Phase (Weeks16-104)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="73">There are fewer participants in this period because some stopped the study at or prior to Week 16.</participants>
                <participants group_id="P5" count="74">There are fewer participants in this period because some stopped the study at or prior to Week 16.</participants>
                <participants group_id="P6" count="80">There are fewer participants in this period because some stopped the study at or prior to Week 16.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="73">Safety population includes all participants who received at least one dose of study drug.</participants>
                <participants group_id="P5" count="74">Safety population includes all participants who received at least one dose of study drug.</participants>
                <participants group_id="P6" count="79">Safety population includes all participants who received at least one dose of study drug.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="41"/>
                <participants group_id="P6" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="26"/>
                <participants group_id="P5" count="33"/>
                <participants group_id="P6" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance With Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="13"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized population includes all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="B2">
          <title>Apremilast Plus Placebo Injection</title>
          <description>Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="B3">
          <title>Etanercept Plus Placebo Tablet</title>
          <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="B4">
          <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="84"/>
            <count group_id="B2" value="83"/>
            <count group_id="B3" value="83"/>
            <count group_id="B4" value="250"/>
          </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="43.4" spread="14.91"/>
                    <measurement group_id="B2" value="46.0" spread="13.59"/>
                    <measurement group_id="B3" value="47.0" spread="14.07"/>
                    <measurement group_id="B4" value="45.4" spread="14.23"/>
                  </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="25"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline</title>
        <description>PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline</title>
          <description>PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
          <population>The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9"/>
                    <measurement group_id="O2" value="39.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>The two-sided p-value is from a CMH test stratified by the BMI at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted Difference</param_type>
            <param_value>27.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.9</ci_lower_limit>
            <ci_upper_limit>40.1</ci_upper_limit>
            <estimate_desc>The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16</title>
        <description>PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>mITT population consisted of all participants who were re-randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Etanercept 50mg Plus Placebo Tablet</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16</title>
          <description>PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
          <population>mITT population consisted of all participants who were re-randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9"/>
                    <measurement group_id="O2" value="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The two-sided p-value is from a CMH test stratified by the BMI at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted Difference</param_type>
            <param_value>35.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.3</ci_lower_limit>
            <ci_upper_limit>48.5</ci_upper_limit>
            <estimate_desc>The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
        <description>The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept Plus Placebo Tablet</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
          <description>The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.</description>
          <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="21.7"/>
                    <measurement group_id="O3" value="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0005</p_value>
            <p_value_desc>The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>The p-value is from a CMH test stratified by the BMI at screening.</method_desc>
            <param_type>Adjusted Difference</param_type>
            <param_value>18.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.4</ci_lower_limit>
            <ci_upper_limit>27.7</ci_upper_limit>
            <estimate_desc>The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.</method_desc>
            <param_type>Adjusted Difference</param_type>
            <param_value>25.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.8</ci_lower_limit>
            <ci_upper_limit>35.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
        <description>BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot; including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept Plus Placebo Tablets</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
          <description>BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot; including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA.</description>
          <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.3" lower_limit="-23.71" upper_limit="-8.81"/>
                    <measurement group_id="O2" value="-47.7" lower_limit="-55.20" upper_limit="-40.12"/>
                    <measurement group_id="O3" value="-56.1" lower_limit="-63.63" upper_limit="-48.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.</method_desc>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-31.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-43.33</ci_lower_limit>
            <ci_upper_limit>-19.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.</method_desc>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-39.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.78</ci_lower_limit>
            <ci_upper_limit>-27.92</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
        <description>PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept Plus Placebo Tablet</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
          <description>PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.</description>
          <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="62.7"/>
                    <measurement group_id="O3" value="83.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>The two-sided p-value is from a CMH test stratified by the BMI at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted Difference</param_type>
            <param_value>29.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.9</ci_lower_limit>
            <ci_upper_limit>43.9</ci_upper_limit>
            <estimate_desc>The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The two-sided p-value is from a CMH test stratified by the BMI at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted Difference</param_type>
            <param_value>49.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>36.9</ci_lower_limit>
            <ci_upper_limit>62.7</ci_upper_limit>
            <estimate_desc>The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
        <description>DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from &quot;Very Much&quot; (score 3) to &quot;Not at All&quot; or &quot;Not relevant&quot; (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if &quot;No,&quot; then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being &quot;A lot,&quot; &quot;A little,&quot; or &quot;Not at all&quot; (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30mg Plus Placebo Injection</title>
            <description>Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept 50mg Plus Placebo Tablet</title>
            <description>Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
          <description>DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from &quot;Very Much&quot; (score 3) to &quot;Not at All&quot; or &quot;Not relevant&quot; (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if &quot;No,&quot; then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being &quot;A lot,&quot; &quot;A little,&quot; or &quot;Not at all&quot; (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.</description>
          <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" lower_limit="-5.34" upper_limit="-2.42"/>
                    <measurement group_id="O2" value="-8.4" lower_limit="-9.84" upper_limit="-6.88"/>
                    <measurement group_id="O3" value="-7.8" lower_limit="-9.28" upper_limit="-6.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.</method_desc>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-4.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.82</ci_lower_limit>
            <ci_upper_limit>-2.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.</method_desc>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-3.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.27</ci_lower_limit>
            <ci_upper_limit>-1.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
        <description>The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept Plus Placebo Tablets</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
          <description>The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value.</description>
          <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="0.72" upper_limit="4.43"/>
                    <measurement group_id="O2" value="3.5" lower_limit="1.62" upper_limit="5.38"/>
                    <measurement group_id="O3" value="4.8" lower_limit="2.92" upper_limit="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.7112</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.</method_desc>
            <param_type>Difference in LS Mean</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.05</ci_lower_limit>
            <ci_upper_limit>3.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1719</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.</method_desc>
            <param_type>Difference in LS Mean</param_type>
            <param_value>2.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>5.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
        <description>The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept Plus Placebo Tablets</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16</title>
          <description>The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.</description>
          <population>mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0"/>
                    <measurement group_id="O2" value="24.1"/>
                    <measurement group_id="O3" value="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0011</p_value>
            <p_value_desc>The two-sided p-value is from a CMH test stratified by the BMI at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted Difference</param_type>
            <param_value>18.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.6</ci_lower_limit>
            <ci_upper_limit>28.6</ci_upper_limit>
            <estimate_desc>The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0021</p_value>
            <p_value_desc>The two-sided p-value is from a CMH test stratified by the BMI at screening.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted Difference</param_type>
            <param_value>16.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.5</ci_lower_limit>
            <ci_upper_limit>26.9</ci_upper_limit>
            <estimate_desc>The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase</title>
        <description>A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.</description>
        <time_frame>Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group</time_frame>
        <population>Safety population includes all participants who were randomized and received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept Plus Placebo Tablets</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase</title>
          <description>A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.</description>
          <population>Safety population includes all participants who were randomized and received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Severe TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Drug Interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Drug Withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period</title>
        <description>A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.</description>
        <time_frame>From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose</time_frame>
        <population>All participants who received apremilast at any time during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Apremilast</title>
            <description>Participants received identically matching placebo tablets PO BID and SC saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast/Apremilast</title>
            <description>Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept/Apremilast</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period</title>
          <description>A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.</description>
          <population>All participants who received apremilast at any time during the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Severe TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Drug Interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Drug Withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Flare/Rebound</title>
        <description>Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.</description>
        <time_frame>Week 0 to Week 16; Placebo controlled phase</time_frame>
        <population>Safety population includes all participants who were randomized and received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O2">
            <title>Apremilast Plus Placebo Injection</title>
            <description>Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
          <group group_id="O3">
            <title>Etanercept Plus Placebo Tablets</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Flare/Rebound</title>
          <description>Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.</description>
          <population>Safety population includes all participants who were randomized and received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any psoriasis flare captured as a TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any psoriasis rebound captured as a TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Those with PASI ≥125% baseline score and D/C APR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Flare/Rebound</title>
        <description>Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.</description>
        <time_frame>From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.</time_frame>
        <population>Safety population includes all participants who were randomized and received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Apremilast</title>
            <description>Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast/Apremilast</title>
            <description>Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept/Apremilast</title>
            <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Flare/Rebound</title>
          <description>Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.</description>
          <population>Safety population includes all participants who were randomized and received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any psoriasis flare captured as a TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any psoriasis rebound captured as a TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Those with PASI ≥125% baseline score and D/C APR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.</time_frame>
      <desc>The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Week 0-16)</title>
          <description>Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="E2">
          <title>Apremilast Plus Placebo Injection (Week 0-16)</title>
          <description>Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="E3">
          <title>Etanercept Plus Placebo Tablets (Week 0-16)</title>
          <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase</description>
        </group>
        <group group_id="E4">
          <title>Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104</title>
          <description>Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.</description>
        </group>
        <group group_id="E5">
          <title>APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104</title>
          <description>Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.</description>
        </group>
        <group group_id="E6">
          <title>Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104</title>
          <description>Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 14.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Abscess intestinal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Salpingo-oophoritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumocephalus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus ureteric</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 14.0</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="25" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="30" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="52" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="32" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="79"/>
              </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="2" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Psoriatic arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tension Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rebound psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="79"/>
              </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>Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 12 months since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anne McClain, Senior Manager, Clinical Trial Disclosure</name_or_title>
      <organization>Celgene Corporation</organization>
      <phone>888-260-1599</phone>
      <email>clinicaltrialdisclosure@celgene.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/NCT01690299
org study id: CC-10004-PSOR-010
secondary id: 2012-000859-14
nct id: NCT01690299
lead sponsor: 
has dmc: Yes
This study will test the clinical effectiveness and safety of apremilast compared with
      placebo as well as etanercept compared with placebo in the same group of patients with
      moderate to severe plaque psoriasis.
This is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy,
      study of the efficacy and safety of apremilast, etanercept, and placebo, in adults with
      moderate to severe plaque psoriasis.

      250 participants will be randomized 1:1:1 to the three treatment groups. All subjects will
      receive both tablets and injections through Week 16.

      The study will consist of four phases:

        -  Screening Phase - up to 35 days

        -  Double-blind Placebo-controlled Phase - Weeks 0-16

        -  Apremilast Extension Phase - Weeks 16-104

        -  Post-treatment Observational Follow-up Phase

      During the double-blind, placebo-controlled phase, subjects will receive treatment with one
      of the following:

        -  apremilast (APR) 30 mg tablets orally twice a day (BID) plus once weekly (QW)
           evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections (1 mL x 2
           injections SC), or

        -  etanercept (ETN) 50 mg evaluator/subject-blinded subcutaneous (SC) once weekly (QW)
           injections (2 x 25 mg) plus placebo tablets orally twice a day (BID), or

        -  placebo tablets and evaluator/subject-blinded subcutaneous (SC) saline (placebo)
           injections.

      All subjects will be asked to participate in a 4-week Post-treatment Observational Follow-up
      Phase either upon completion of the study or upon discontinuation of investigational product
      for those subjects who terminate the study early.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline
time frame: Baseline to Week 16
description: PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.
measure: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16
time frame: Baseline and Week 16
description: PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.
measure: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline and Week 16
description: The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.
measure: Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
description: BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA.
measure: Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
description: PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
description: DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
measure: Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
description: The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value.
measure: Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
description: The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
time frame: Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group
description: A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
time frame: From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose
description: A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.
measure: Psoriasis Flare/Rebound
time frame: Week 0 to Week 16; Placebo controlled phase
description: Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.
measure: Psoriasis Flare/Rebound
time frame: From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.
description: Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.
arm group label: Apremilast 30 mg plus placebo injection
arm group type: Experimental
description: Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections
arm group label: Etanercept 50 mg plus placebo tablet
arm group type: Experimental
description: Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID
arm group label: Oral placebo tablets plus SC placebo injections
arm group type: Placebo Comparator
description: Identically matching placebo tablets and evaluator/subject-blinded SC injections
intervention type: Drug
intervention name: Apremilast
description: Apremilast 30 mg tablet orally BID
arm group label: Apremilast 30 mg plus placebo injection
other name: CC-10004
other name: Otezla
intervention type: Drug
intervention name: Etanercept
description: Etanercept 50 mg evaluator/subject-blinded SC QW injection
arm group label: Etanercept 50 mg plus placebo tablet
other name: Enbrel
intervention type: Drug
intervention name: Placebo tablet
description: Placebo tablets BID
arm group label: Etanercept 50 mg plus placebo tablet
arm group label: Oral placebo tablets plus SC placebo injections
intervention type: Drug
intervention name: Placebo injection
description: Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
arm group label: Apremilast 30 mg plus placebo injection
arm group label: Oral placebo tablets plus SC placebo injections
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Belgium
country: Canada
country: Czechia
country: Estonia
country: Germany
country: Hungary
country: Latvia
country: Netherlands
country: United Kingdom
country: United States
country: Czech Republic
citation: Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.
PMID: 34255891
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Psoriasis
mesh term: Etanercept
mesh term: Apremilast
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: http://www.amgen.com/datasharing
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 