xml: <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/NCT06030076</url>
    </required_header>
    <id_info>
      <org_study_id>SW-ATCH</org_study_id>
      <nct_id>NCT06030076</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis</brief_title>
    <official_title>A Non-interventional, Prospective Cohort, Multicentre, Real-world Evidence Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis in Austria and Switzerland</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Almirall, S.A.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Almirall, S.A.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main aim of this study is to assess the effects of switching from another biologic to&#xD;
        tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's&#xD;
        quality of life prior and after switching and the individual rationales for switching&#xD;
        biologics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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 Satisfaction Questionnaire for Medication-11 (TSQM-11) Score</measure>
      <time_frame>Baseline, Week 28</time_frame>
      <description>TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>World Health Organisation Well-Being Index (WHO-5) Score</measure>
      <time_frame>Baseline up to Week 28</time_frame>
      <description>The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score</measure>
      <time_frame>Baseline, Week 4, 16 and 28</time_frame>
      <description>The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Physician's Global Assessment (PGA) Score</measure>
      <time_frame>Baseline, Week 4, 16 and 28</time_frame>
      <description>The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Dermatology Life Quality Index (DLQI) Score</measure>
      <time_frame>Baseline, Week 4, 16 and 28</time_frame>
      <description>The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab</measure>
      <time_frame>At Baseline</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Plaque Psoriasis</condition>
    <arm_group>
      <arm_group_label>Tildrakizumab</arm_group_label>
      <description>Participants who have been prescribed tildrakizumab to manage moderate-to-severe plaque psoriasis according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 28 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tildrakizumab</intervention_name>
      <description>As provided in real-world clinical practice.</description>
      <arm_group_label>Tildrakizumab</arm_group_label>
      <other_name>Ilumetri®</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult male and female participants with moderate to severe plaque psoriasis will be&#xD;
          observed in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent.&#xD;
  &#xD;
            2. &gt;=18 years of age.&#xD;
  &#xD;
            3. Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα&#xD;
               antagonist, IL12/23 antagonist, IL17 antagonist).&#xD;
  &#xD;
            4. Switch to tildrakizumab due to:&#xD;
  &#xD;
                 1. primary or secondary treatment failure (PASI &gt;= 3 or ΔPASI &lt; 75 and/or DLQI &gt; 5)&#xD;
  &#xD;
                 2. adverse events, contraindication, intolerance&#xD;
  &#xD;
                 3. patient wish (dosing regimen), lack of adherence, or other, including nonmedical&#xD;
                    reason&#xD;
  &#xD;
            5. Treatment with tildrakizumab planned in the frame of clinical practice.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient appears to be unwilling or unable to comply with the requirements of the study&#xD;
               or who, in the opinion of the Investigator, should not participate in the study.&#xD;
  &#xD;
            2. &gt;=3 previous biologic treatments in the last 3 years.&#xD;
  &#xD;
            3. Participation in a clinical trial simultaneous to participation in SW-ATCH.&#xD;
  &#xD;
            4. Any condition preventing prescription of Tildrakizumab according to the SmPC,&#xD;
               including but not restricted to any contraindication or history of hypersensitivity or&#xD;
               intolerance.&#xD;
  &#xD;
            5. Patient dependent on the Investigator.&#xD;
  &#xD;
            6. Previous treatment with Tildrakizumab.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Psoriasis</keyword>
    <keyword>Tildrakizumab</keyword>
    <keyword>Moderate-to-severe plaque psoriasis</keyword>
    <keyword>Prospective</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psoriasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030076
  org study id: SW-ATCH
  nct id: NCT06030076
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main aim of this study is to assess the effects of switching from another biologic to
        tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's
        quality of life prior and after switching and the individual rationales for switching
        biologics.
  observational model: Cohort
  time perspective: Prospective
  measure: Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score
  time frame: Baseline, Week 28
  description: TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.
  measure: World Health Organisation Well-Being Index (WHO-5) Score
  time frame: Baseline up to Week 28
  description: The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
  measure: Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score
  time frame: Baseline, Week 4, 16 and 28
  description: The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.
  measure: Change from Baseline in Physician's Global Assessment (PGA) Score
  time frame: Baseline, Week 4, 16 and 28
  description: The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.
  measure: Change from Baseline in Dermatology Life Quality Index (DLQI) Score
  time frame: Baseline, Week 4, 16 and 28
  description: The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.
  measure: Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab
  time frame: At Baseline
  arm group label: Tildrakizumab
  description: Participants who have been prescribed tildrakizumab to manage moderate-to-severe plaque psoriasis according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 28 weeks.
  intervention type: Drug
  intervention name: Tildrakizumab
  description: As provided in real-world clinical practice.
  arm group label: Tildrakizumab
  other name: Ilumetri®
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Psoriasis
  sharing ipd: No