<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/NCT03828045</url>
  </required_header>
  <id_info>
    <org_study_id>CC-10004-PSA-015</org_study_id>
    <secondary_id>U1111-1221-8638</secondary_id>
    <nct_id>NCT03828045</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment</brief_title>
  <acronym>PREVAIL</acronym>
  <official_title>Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational, prospective and multicenter study in approximately 25 sites nationwide. The&#xD;
      investigators participating in this study will be rheumatologists specializing in this&#xD;
      pathology.&#xD;
&#xD;
      The study will include patients diagnosed with PsA (according to the CASPAR diagnosis&#xD;
      criteria), naïve to biological treatments, who have - following the routine practice in their&#xD;
      centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in&#xD;
      the study, irrespective of treatment duration.&#xD;
&#xD;
      Recruitment will be consecutive and the reason for not including a potential candidate&#xD;
      patient will be registered. The decision to prescribe apremilast treatment should be clearly&#xD;
      dissociated from the inclusion of the patient in the study, which will not occur earlier than&#xD;
      6 months (± 4 weeks after treatment start). Therefore, the choice of the therapeutic strategy&#xD;
      will be made independently by the physician.&#xD;
&#xD;
      Before entering the study, all patients shall sign an informed consent to participate in the&#xD;
      study, including permission to retrieve data from their medical records and to complete&#xD;
      questionnaires regarding their quality of life.&#xD;
&#xD;
      To avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all&#xD;
      consecutive patients who attend to a routine follow-up visit and have been prescribed&#xD;
      apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the&#xD;
      study. All consecutive patients who can be contacted 6 months (+/- 4 weeks) following&#xD;
      initiation of treatment with apremilast will be approached for entry to minimize bias in&#xD;
      patient selection&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Actual">October 20, 2021</completion_date>
  <primary_completion_date type="Actual">October 20, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment persistence at 6 months after initiating apremilast treatment</measure>
    <time_frame>Up to approximately 6 months</time_frame>
    <description>Percentage of patients still being treated with apremilast after 6 months of initiating treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics</measure>
    <time_frame>Up to approximately 6 months</time_frame>
    <description>Description of the demographic at time of initiating treatment with apremilast</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the characteristics of apremilast treatment (i.e., dosage and regimen) in patients with PsA who start treatment according to the routine clinical practice.</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>To capture the changes in dose and regimen of apremilast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the persistence of apremilast treatment after 12 months of treatment start</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Percentage of patients still being treated with apremilast after 12 months of initiating treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the disease activity at 6 and 12 months of treatment with apremilast.</measure>
    <time_frame>At 6 and 12 months</time_frame>
    <description>The disease activity will be assessed by the DAPSA scale when the information available in the patient's medical record allows the estimation of the DAPSA score. Otherwise, the individual items of the DAPSA scale will be described separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on clinical enthesitis and dactilitis</measure>
    <time_frame>UP to approximately 12 months</time_frame>
    <description>Assessment of the changes on clinical enthesitis and dactilitis count after 6 and 12 months of treatment with apremilast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender joints count</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Change from baseline in the joints deemed tender as per joint count assessment by physical exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swollen joints count</measure>
    <time_frame>UP to approximately 12 months</time_frame>
    <description>Change from baseline in the joints deemed tender as per joint count assessment by physical exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the plasma concentration of C-reactive protein.</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Assessment of the change in the plasma concentration of C-reactive protein after 6 and 12 months of apremilast treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Assessment of Disease Activity (PGA).</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Assessment of the Physician Global Assessment of Disease Activity (PGA) after 6 and 12 months of apremilast treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast.</measure>
    <time_frame>UP to approximately 12 months</time_frame>
    <description>Joint erosion will be assessed radiologically, as regularly assessed in the routine practice of each center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The VITACORA-19 questionnaires</measure>
    <time_frame>UP to approximately 12 months</time_frame>
    <description>are used to assess the health-related quality of life of patients with PsA in the setting of clinical trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires</measure>
    <time_frame>UP to approximately 12 months</time_frame>
    <description>was developed under a 13-country EULAR initiative to evaluate the impact of psoriatic arthritis in clinical practice . The version used in this study (PsAID-9) consists of 9 items addressing pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleeping disturbances, coping, and anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of changes on affected joints</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Assessment of the changes on affected joints count after 6 and 12 months of treatment with apremilast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of DAPSA/cDAPSA scores</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Assessment of the changes of the DAPSA/cDAPSA score at 6/12 month after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. The Pearson or Spearman correlation will be performed to evaluate the relationship between these variables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Number participants with adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment.</measure>
    <time_frame>UP to approximately 12 months</time_frame>
    <description>To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">119</enrollment>
  <condition>Arthritis, Psoriatic</condition>
  <arm_group>
    <arm_group_label>Psoriatic Arthritis patients on Apremilast</arm_group_label>
    <description>Patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apremilast</intervention_name>
    <description>Apremilast</description>
    <arm_group_label>Psoriatic Arthritis patients on Apremilast</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Observational, prospective and multicenter study in approximately 25 sites nationwide. The&#xD;
        investigators participating in this study will be rheumatologists specializing in this&#xD;
        pathology.&#xD;
&#xD;
        The study will include patients diagnosed with PsA (according to the CASPAR diagnosis&#xD;
        criteria), naïve to biological treatments, who have - following the routine practice in&#xD;
        their centers - initiated treatment with apremilast 6 months (±1 months) before their&#xD;
        inclusion in the study, irrespective of treatment duration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women older than 18 years.&#xD;
&#xD;
          -  Patients diagnosed with psoriatic arthritis according to the CASPAR criteria*.&#xD;
&#xD;
          -  Patients who, following the routine clinical practice, initiated treatment with&#xD;
             apremilast 6 months (±4 weeks) before their inclusion in the study.&#xD;
&#xD;
          -  Patients naive to biologic treatments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who reject to sign the informed consent.&#xD;
&#xD;
          -  Patients enrolled in a clinical trial within the 4 weeks preceding the baseline visit&#xD;
             or for the duration of apremilast treatment.&#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>H Son Espases</name>
      <address>
        <city>Mallorca</city>
        <state>Baleares</state>
        <zip>07120b</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Son Llatzer</name>
      <address>
        <city>Mallorca</city>
        <state>Baleares</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Univ Canarias</name>
      <address>
        <city>Tenerife</city>
        <state>Canarias</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Parc Tauli</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Bellvitge</name>
      <address>
        <city>L'Hospitalet Del Llobregat</city>
        <state>Cataluña</state>
        <zip>8907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Santa Maria Lleida</name>
      <address>
        <city>Lérida</city>
        <state>Cataluña</state>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Joan XXIII</name>
      <address>
        <city>Tarragona</city>
        <state>Cataluña</state>
        <zip>43005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Mérida</name>
      <address>
        <city>Badajoz</city>
        <state>Extremadura</state>
        <zip>06800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Virgen del Puerto</name>
      <address>
        <city>Caceres</city>
        <state>Extremadura</state>
        <zip>10600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Txagorritxu de Vitoria</name>
      <address>
        <city>Vitoria</city>
        <state>País Vasco</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Perpetuo Socorro</name>
      <address>
        <city>Badajoz</city>
        <zip>06010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Donostia</name>
      <address>
        <city>Donostia</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Can Misses</name>
      <address>
        <city>Eivissa</city>
        <zip>07800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Santa Lucía</name>
      <address>
        <city>Murcia</city>
        <zip>30202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Monte Naranco</name>
      <address>
        <city>Oviedo</city>
        <zip>33012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H l Esperit Sant</name>
      <address>
        <city>Santa Coloma de Gramenet</city>
        <zip>08923</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Vaudoise*</name>
      <address>
        <city>Vigo</city>
        <zip>36213</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>October 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriatic Arthritis</keyword>
  <keyword>Apremilast</keyword>
  <keyword>CC-10004</keyword>
  <keyword>Biologic Treatments</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apremilast</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828045
org study id: CC-10004-PSA-015
secondary id: U1111-1221-8638
nct id: NCT03828045
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Observational, prospective and multicenter study in approximately 25 sites nationwide. The
      investigators participating in this study will be rheumatologists specializing in this
      pathology.

      The study will include patients diagnosed with PsA (according to the CASPAR diagnosis
      criteria), naïve to biological treatments, who have - following the routine practice in their
      centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in
      the study, irrespective of treatment duration.

      Recruitment will be consecutive and the reason for not including a potential candidate
      patient will be registered. The decision to prescribe apremilast treatment should be clearly
      dissociated from the inclusion of the patient in the study, which will not occur earlier than
      6 months (± 4 weeks after treatment start). Therefore, the choice of the therapeutic strategy
      will be made independently by the physician.

      Before entering the study, all patients shall sign an informed consent to participate in the
      study, including permission to retrieve data from their medical records and to complete
      questionnaires regarding their quality of life.

      To avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all
      consecutive patients who attend to a routine follow-up visit and have been prescribed
      apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the
      study. All consecutive patients who can be contacted 6 months (+/- 4 weeks) following
      initiation of treatment with apremilast will be approached for entry to minimize bias in
      patient selection
observational model: Cohort
time perspective: Prospective
measure: Treatment persistence at 6 months after initiating apremilast treatment
time frame: Up to approximately 6 months
description: Percentage of patients still being treated with apremilast after 6 months of initiating treatment
measure: Demographic characteristics
time frame: Up to approximately 6 months
description: Description of the demographic at time of initiating treatment with apremilast
measure: To describe the characteristics of apremilast treatment (i.e., dosage and regimen) in patients with PsA who start treatment according to the routine clinical practice.
time frame: Up to approximately 12 months
description: To capture the changes in dose and regimen of apremilast.
measure: To assess the persistence of apremilast treatment after 12 months of treatment start
time frame: Up to approximately 12 months
description: Percentage of patients still being treated with apremilast after 12 months of initiating treatment
measure: To assess the disease activity at 6 and 12 months of treatment with apremilast.
time frame: At 6 and 12 months
description: The disease activity will be assessed by the DAPSA scale when the information available in the patient's medical record allows the estimation of the DAPSA score. Otherwise, the individual items of the DAPSA scale will be described separately.
measure: Changes on clinical enthesitis and dactilitis
time frame: UP to approximately 12 months
description: Assessment of the changes on clinical enthesitis and dactilitis count after 6 and 12 months of treatment with apremilast.
measure: Tender joints count
time frame: Up to approximately 12 months
description: Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
measure: Swollen joints count
time frame: UP to approximately 12 months
description: Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
measure: Changes in the plasma concentration of C-reactive protein.
time frame: Up to approximately 12 months
description: Assessment of the change in the plasma concentration of C-reactive protein after 6 and 12 months of apremilast treatment.
measure: Physician Global Assessment of Disease Activity (PGA).
time frame: Up to approximately 12 months
description: Assessment of the Physician Global Assessment of Disease Activity (PGA) after 6 and 12 months of apremilast treatment.
measure: To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast.
time frame: UP to approximately 12 months
description: Joint erosion will be assessed radiologically, as regularly assessed in the routine practice of each center.
measure: The VITACORA-19 questionnaires
time frame: UP to approximately 12 months
description: are used to assess the health-related quality of life of patients with PsA in the setting of clinical trials
measure: The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires
time frame: UP to approximately 12 months
description: was developed under a 13-country EULAR initiative to evaluate the impact of psoriatic arthritis in clinical practice . The version used in this study (PsAID-9) consists of 9 items addressing pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleeping disturbances, coping, and anxiety
measure: Assessment of changes on affected joints
time frame: Up to approximately 12 months
description: Assessment of the changes on affected joints count after 6 and 12 months of treatment with apremilast.
measure: Assessment of DAPSA/cDAPSA scores
time frame: Up to approximately 12 months
description: Assessment of the changes of the DAPSA/cDAPSA score at 6/12 month after treatment.
measure: To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.
time frame: Up to approximately 12 months
description: Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. The Pearson or Spearman correlation will be performed to evaluate the relationship between these variables
measure: Adverse events (AEs)
time frame: Up to approximately 12 months
description: Number participants with adverse events.
measure: To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment.
time frame: UP to approximately 12 months
description: To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.
arm group label: Psoriatic Arthritis patients on Apremilast
description: Patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.
intervention type: Drug
intervention name: Apremilast
description: Apremilast
arm group label: Psoriatic Arthritis patients on Apremilast
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Apremilast