<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/NCT03828643</url>
  </required_header>
  <id_info>
    <org_study_id>Gisondi 3</org_study_id>
    <nct_id>NCT03828643</nct_id>
  </id_info>
  <brief_title>Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis</brief_title>
  <official_title>Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universita di Verona</source>
  <oversight_info>
    <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>
      This was a retrospective, observational study. The objective of the study is investigate the&#xD;
      efficacy and safety of secukinumab without the initial weekly loading dose in patients with&#xD;
      chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab&#xD;
      at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the&#xD;
      initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the&#xD;
      proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and&#xD;
      controls. Safety was evaluated by reporting every adverse events up to week 48.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">April 12, 2019</completion_date>
  <primary_completion_date type="Actual">April 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PASI75</measure>
    <time_frame>week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PASI90</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">156</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Secukinumab</intervention_name>
    <description>Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.</description>
    <arm_group_label>Cases</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Secukinumab</intervention_name>
    <description>Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.</description>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with moderate to severe chronic plaque psoriasis attended two Dermatological&#xD;
        centers of North Italy in Veneto (Azienda Ospedaliera Universitaria of Verona and Azienda&#xD;
        Ospedaliera of Padua) dedicated to the care of patients with psoriasis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old&#xD;
&#xD;
          -  Patients with moderate to severe chronic plaque psoriasis treated with secukinumab&#xD;
             with or without initial loading dose for at least 48 week&#xD;
&#xD;
          -  The criteria for receiving secukinumab were according to standard clinical practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years old&#xD;
&#xD;
          -  Patients with only psoriatic arthritis or with other forms of psoriasis than chronic&#xD;
             plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular&#xD;
             psoriasis)&#xD;
&#xD;
          -  Pregnant women and women during breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Verona</name>
      <address>
        <city>Verona</city>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>Paolo Gisondi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Secukinumab</keyword>
  <keyword>loading dose</keyword>
  <keyword>chronic plaque psoriasis</keyword>
  <keyword>no loading dose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03828643
org study id: Gisondi 3
nct id: NCT03828643
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This was a retrospective, observational study. The objective of the study is investigate the
      efficacy and safety of secukinumab without the initial weekly loading dose in patients with
      chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab
      at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the
      initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the
      proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and
      controls. Safety was evaluated by reporting every adverse events up to week 48.
observational model: Case-Control
time perspective: Retrospective
measure: PASI75
time frame: week 48
measure: PASI90
time frame: week 48
arm group label: Cases
description: Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.
arm group label: Controls
description: Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
intervention type: Drug
intervention name: Secukinumab
description: Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.
arm group label: Cases
intervention type: Drug
intervention name: Secukinumab
description: Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.
arm group label: Controls
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: Paolo Gisondi
investigator title: Professor
mesh term: Psoriasis
mesh term: Antibodies, Monoclonal
sharing ipd: Undecided