<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/NCT01706692</url>
  </required_header>
  <id_info>
    <org_study_id>IMM 10-0138; P21007224R</org_study_id>
    <secondary_id>CNTO1275PSO4028; AG110401-IIR</secondary_id>
    <nct_id>NCT01706692</nct_id>
  </id_info>
  <brief_title>Swiss Dermatology Network of Targeted Therapies (SDNTT)</brief_title>
  <acronym>SDNTT</acronym>
  <official_title>Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Dermatology Network for Targeted Therapies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Dermatology Network for Targeted Therapies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term course of patients with psoriasis and&#xD;
      psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric&#xD;
      acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A&#xD;
      patient will be included at first initiation of the treatment and will remain in the registry&#xD;
      for 10 years, regardless of subsequent therapy.&#xD;
&#xD;
      The registry will also evaluate safety clinical outcomes and health related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland&#xD;
      is largely performed with systemic therapies. This includes conventional systemic therapy&#xD;
      such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and&#xD;
      biological treatments such as etanercept, infliximab, adalimumab and within a&#xD;
      pre-registration program ustekinumab. While short- and middle-term efficacy of most systemic&#xD;
      treatments has been shown in clinical studies (and is incorporated in international&#xD;
      guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under&#xD;
      real-world conditions is still missing. SDNTT, the Swiss registry on the treatment of&#xD;
      moderate to severe Pso and PsA documents the long-term course of patients being administered&#xD;
      a defined biologic or conventional systemic drug. Following outcomes are observed:&#xD;
      Effectiveness on the long-term, of combined/alternating treatments and under comorbidity&#xD;
      conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of&#xD;
      response and safety.&#xD;
&#xD;
      The study evaluates the long-term course of patients with Pso and PsA in systemic treatments.&#xD;
      A patient will be included at first initiation of the treatment and will remain in the&#xD;
      registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term&#xD;
      approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and&#xD;
      biologic treatment will consecutively enroll patients. Follow-ups will be every 3 months,&#xD;
      comprising patient and treatment characteristics, clinical parameters, patient-defined&#xD;
      benefit, quality of life and adverse events. Standardized questionnaires will be addressed to&#xD;
      the patient and to the dermatologist 12 times at the dermatologic centres. In interim&#xD;
      intervals, patients are directly contacted another 9 times by mail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">June 2033</completion_date>
  <primary_completion_date type="Anticipated">June 2032</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>Psoriasis Area Severity Index (PASI)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
    <description>To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
    <description>To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse and serious adverse events</measure>
    <time_frame>10 years</time_frame>
    <description>Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis</description>
  </other_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Adalimumab</arm_group_label>
    <description>Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etanercept</arm_group_label>
    <description>Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infliximab</arm_group_label>
    <description>Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ustekinumab</arm_group_label>
    <description>Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cyclosporine A</arm_group_label>
    <description>Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fumaric acids</arm_group_label>
    <description>Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methotrexate</arm_group_label>
    <description>Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other anti-psoriatic systemic treatments</arm_group_label>
    <description>e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Adalimumab</arm_group_label>
    <other_name>Humira</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Etanercept</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Etanercept</arm_group_label>
    <other_name>Enbrel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Infliximab</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Infliximab</arm_group_label>
    <other_name>Remicade</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ustekinumab</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Ustekinumab</arm_group_label>
    <other_name>Stelara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporine A</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Cyclosporine A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fumaric acids</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Fumaric acids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Methotrexate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other anti-psoriatic systemic treatments</intervention_name>
    <description>all dosages, frequencies and durations prescribed</description>
    <arm_group_label>Other anti-psoriatic systemic treatments</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient with psoriasis or psoriatic-arthritis meeting the inclusion criteria and not&#xD;
        meeting the exclusion criteria will be eligible to participate in this registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a&#xD;
             dermatologist,&#xD;
&#xD;
          -  age ≥ 18,&#xD;
&#xD;
          -  Being administered a specific biologic/conventional systemic drug for the first time&#xD;
&#xD;
          -  Sufficient language skills (German, French, Italian and English) for the informed&#xD;
             consent to participate&#xD;
&#xD;
          -  Informed consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  Patients being participants of clinical trials at the day of registration to the&#xD;
             registry (if a patient is included into a clinical trial during the registry&#xD;
             follow-ups, the patient data will be recorded, but analyzed separately)&#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>Alexander Navarini, Prof Dr med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Society of Dermatology and Venereology (SSDV)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julia-Tatjana Maul, PD Dr med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Society of Dermatology and Venereology (SSDV)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarau Cantonal Hospital</name>
      <address>
        <city>Aarau</city>
        <zip>CH-5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcus Streit, Dr. med.</last_name>
      <phone>062 838 68 38</phone>
      <email>markus.streit@ksa.ch</email>
    </contact>
    <investigator>
      <last_name>Marcus Streit, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Basel University Hospital</name>
      <address>
        <city>Basel</city>
        <zip>CH-4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Navarini, Prof.</last_name>
      <email>Alexander.Navarini@usb.ch</email>
    </contact>
    <investigator>
      <last_name>Alexander Navarini, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inselspital - Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>CH-3001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca Borradori, Prof.</last_name>
      <phone>031 632 2111</phone>
      <email>Luca.Borradori@insel.ch</email>
    </contact>
    <contact_backup>
      <last_name>Nikhil Yawalkar, Prof.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Nikhil Yawalkar, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois (CHUV)</name>
      <address>
        <city>Lausanne</city>
        <zip>CH-1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel Gilliet, Prof.</last_name>
      <email>michel.gilliet@chuv.ch</email>
    </contact>
    <investigator>
      <last_name>Curdin Conrad, PD Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Gallen Cantonal Hospital</name>
      <address>
        <city>St. Gallen</city>
        <zip>CH-9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Cozzio, Prof.</last_name>
      <email>Antonio.Cozzio@kssg.ch</email>
    </contact>
    <investigator>
      <last_name>Antonio Cozzio, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zurich University Hospital</name>
      <address>
        <city>Zurich</city>
        <zip>CH-8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tatjana Maul, PD Dr.</last_name>
      <email>Julia-Tatjana.Maul@usz.ch</email>
    </contact>
    <investigator>
      <last_name>Tatjana Maul, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://www.sdntt.ch</url>
    <description>SDNTT</description>
  </link>
  <link>
    <url>http://www.psobest.de/</url>
    <description>German registry PsoBest</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Methotrexate</keyword>
  <keyword>Acitretin</keyword>
  <keyword>Cyclosporine A</keyword>
  <keyword>Systemic PUVA</keyword>
  <keyword>Infliximab</keyword>
  <keyword>Adalimumab</keyword>
  <keyword>Etanercept</keyword>
  <keyword>Ustekinumab</keyword>
  <keyword>Fumaric acids</keyword>
  <keyword>Psoriasis</keyword>
  <keyword>Psoriatic arthritis</keyword>
  <keyword>Skin disease</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>Cyclosporine</mesh_term>
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Infliximab</mesh_term>
    <mesh_term>Etanercept</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Ustekinumab</mesh_term>
    <mesh_term>Cyclosporins</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/NCT01706692
org study id: IMM 10-0138; P21007224R
secondary id: CNTO1275PSO4028; AG110401-IIR
nct id: NCT01706692
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the long-term course of patients with psoriasis and
      psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric
      acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A
      patient will be included at first initiation of the treatment and will remain in the registry
      for 10 years, regardless of subsequent therapy.

      The registry will also evaluate safety clinical outcomes and health related quality of life.
Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland
      is largely performed with systemic therapies. This includes conventional systemic therapy
      such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and
      biological treatments such as etanercept, infliximab, adalimumab and within a
      pre-registration program ustekinumab. While short- and middle-term efficacy of most systemic
      treatments has been shown in clinical studies (and is incorporated in international
      guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under
      real-world conditions is still missing. SDNTT, the Swiss registry on the treatment of
      moderate to severe Pso and PsA documents the long-term course of patients being administered
      a defined biologic or conventional systemic drug. Following outcomes are observed:
      Effectiveness on the long-term, of combined/alternating treatments and under comorbidity
      conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of
      response and safety.

      The study evaluates the long-term course of patients with Pso and PsA in systemic treatments.
      A patient will be included at first initiation of the treatment and will remain in the
      registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term
      approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and
      biologic treatment will consecutively enroll patients. Follow-ups will be every 3 months,
      comprising patient and treatment characteristics, clinical parameters, patient-defined
      benefit, quality of life and adverse events. Standardized questionnaires will be addressed to
      the patient and to the dermatologist 12 times at the dermatologic centres. In interim
      intervals, patients are directly contacted another 9 times by mail.
observational model: Cohort
time perspective: Prospective
measure: Psoriasis Area Severity Index (PASI)
time frame: every 6 months for 10 years
description: To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
measure: Dermatology Life Quality Index (DLQI)
time frame: every 6 months for 10 years
description: To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
measure: Adverse and serious adverse events
time frame: 10 years
description: Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
arm group label: Adalimumab
description: Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed
arm group label: Etanercept
description: Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed
arm group label: Infliximab
description: Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed
arm group label: Ustekinumab
description: Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed
arm group label: Cyclosporine A
description: Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed
arm group label: Fumaric acids
description: Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed
arm group label: Methotrexate
description: Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed
arm group label: Other anti-psoriatic systemic treatments
description: e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed
intervention type: Biological
intervention name: Adalimumab
description: all dosages, frequencies and durations prescribed
arm group label: Adalimumab
other name: Humira
intervention type: Biological
intervention name: Etanercept
description: all dosages, frequencies and durations prescribed
arm group label: Etanercept
other name: Enbrel
intervention type: Biological
intervention name: Infliximab
description: all dosages, frequencies and durations prescribed
arm group label: Infliximab
other name: Remicade
intervention type: Biological
intervention name: Ustekinumab
description: all dosages, frequencies and durations prescribed
arm group label: Ustekinumab
other name: Stelara
intervention type: Drug
intervention name: Cyclosporine A
description: all dosages, frequencies and durations prescribed
arm group label: Cyclosporine A
intervention type: Drug
intervention name: Fumaric acids
description: all dosages, frequencies and durations prescribed
arm group label: Fumaric acids
intervention type: Drug
intervention name: Methotrexate
description: all dosages, frequencies and durations prescribed
arm group label: Methotrexate
intervention type: Drug
intervention name: Other anti-psoriatic systemic treatments
description: all dosages, frequencies and durations prescribed
arm group label: Other anti-psoriatic systemic treatments
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Navarini, Prof Dr med
role: Principal Investigator
affiliation: Swiss Society of Dermatology and Venereology (SSDV)
last name: Julia-Tatjana Maul, PD Dr med
role: Principal Investigator
affiliation: Swiss Society of Dermatology and Venereology (SSDV)
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
url: https://www.sdntt.ch
description: SDNTT
url: http://www.psobest.de/
description: German registry PsoBest
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Cyclosporine
mesh term: Adalimumab
mesh term: Infliximab
mesh term: Etanercept
mesh term: Methotrexate
mesh term: Ustekinumab
mesh term: Cyclosporins