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/NCT05989932</url>
    </required_header>
    <id_info>
      <org_study_id>SID02</org_study_id>
      <nct_id>NCT05989932</nct_id>
    </id_info>
    <brief_title>Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)</brief_title>
    <acronym>ERUDA</acronym>
    <official_title>Esperienza Real-world Sull'Uso di Upadacitinib Nel Trattamento Della Dermatite Atopica Moderata-severa Dell'Adulto</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse</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>
        Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe&#xD;
        atopic dermatitis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Atopic dermatitis (DA) is a chronic-recurrent inflammatory skin disease with high prevalence&#xD;
        in children. Clinical remission is frequently observed during or after childhood although it&#xD;
        may persist and/or recur, even after long and transient remission, in adulthood. In addition,&#xD;
        in some patients the DA begins in adulthood: in these cases, we speak of DA adult-onset. In&#xD;
        addition to the diagnostic framework, it is also important in clinical practice to assess the&#xD;
        severity of the disease on which the choice of treatment is based, which will also take into&#xD;
        account other factors such as: possible comorbidities, Previously performed therapies and&#xD;
        patient needs. For the management of moderate-severe forms of atopic dermatitis topical&#xD;
        drugs, phototherapy, traditional immunomodulating drugs and a biological drug are currently&#xD;
        available. Compared to other chronic inflammatory skin diseases the therapeutic paraphernalia&#xD;
        should be considered limited, with most systemic drugs that have no indication for the&#xD;
        treatment of DA (off-label use).&#xD;
  &#xD;
        In the pipeline there are numerous drugs that have reached an advanced stage of development.&#xD;
        These include upadacitinib, a new-generation oral drug (small molecule) that selectively&#xD;
        inhibits the signal mediated by Janus kinases 1 (JAK-1), has recently received approval for&#xD;
        treatment of DA by EMA and AIFA to begin compassionate use of patients deemed&#xD;
        contraindicated, intolerant, and/or non-responsive to traditional systemic therapies and&#xD;
        biological therapy.&#xD;
  &#xD;
          -  Evaluation of the effectiveness of upadacitinib using the EASI score Secondary&#xD;
             objectives&#xD;
  &#xD;
          -  Evaluation of the safety profile of upadacitinib&#xD;
  &#xD;
          -  Predictive factors of treatment response&#xD;
  &#xD;
          -  Assessment of patient quality of life&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 19, 2021</start_date>
    <completion_date type="Anticipated">November 19, 2031</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>12 Weeks</target_duration>
    <primary_outcome>
      <measure>DLQI</measure>
      <time_frame>baseline and every 12 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>POEM</measure>
      <time_frame>baseline and every 12 weeks</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Atopic Dermatitis</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Upadacitinib</intervention_name>
      <description>Real-world on the use of Upadacitinib</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The nature of the study is descriptive. Each center is committed to enlist consecutively&#xD;
          all adult patients diagnosed with moderate-severe atopic dermatitis treated with&#xD;
          upadacitinib&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 years&#xD;
  &#xD;
            2. Signature of informed consent&#xD;
  &#xD;
            3. Diagnosis of moderate and/or severe DA by a dermatologist specialist&#xD;
  &#xD;
            4. Approval of the compassionate use of upadacitinib&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient unable to give informed consent prior to any collection procedure study data&#xD;
  &#xD;
            2. unable to complete the procedures required for the study&#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_contact>
      <last_name>Ketty MD Peris</last_name>
      <phone>0630154211</phone>
      <email>ketty.peris@unicatt.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Irccs Fondazione Policlinico Gemelli</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ketty MD Peris</last_name>
        <phone>0630154211</phone>
        <email>ketty.peris@unicatt.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Upadacitinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05989932
  org study id: SID02
  nct id: NCT05989932
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe
        atopic dermatitis
  Atopic dermatitis (DA) is a chronic-recurrent inflammatory skin disease with high prevalence
        in children. Clinical remission is frequently observed during or after childhood although it
        may persist and/or recur, even after long and transient remission, in adulthood. In addition,
        in some patients the DA begins in adulthood: in these cases, we speak of DA adult-onset. In
        addition to the diagnostic framework, it is also important in clinical practice to assess the
        severity of the disease on which the choice of treatment is based, which will also take into
        account other factors such as: possible comorbidities, Previously performed therapies and
        patient needs. For the management of moderate-severe forms of atopic dermatitis topical
        drugs, phototherapy, traditional immunomodulating drugs and a biological drug are currently
        available. Compared to other chronic inflammatory skin diseases the therapeutic paraphernalia
        should be considered limited, with most systemic drugs that have no indication for the
        treatment of DA (off-label use).
  
        In the pipeline there are numerous drugs that have reached an advanced stage of development.
        These include upadacitinib, a new-generation oral drug (small molecule) that selectively
        inhibits the signal mediated by Janus kinases 1 (JAK-1), has recently received approval for
        treatment of DA by EMA and AIFA to begin compassionate use of patients deemed
        contraindicated, intolerant, and/or non-responsive to traditional systemic therapies and
        biological therapy.
  
          -  Evaluation of the effectiveness of upadacitinib using the EASI score Secondary
             objectives
  
          -  Evaluation of the safety profile of upadacitinib
  
          -  Predictive factors of treatment response
  
          -  Assessment of patient quality of life
  observational model: Cohort
  time perspective: Other
  measure: DLQI
  time frame: baseline and every 12 weeks
  measure: POEM
  time frame: baseline and every 12 weeks
  intervention type: Other
  intervention name: Upadacitinib
  description: Real-world on the use of Upadacitinib
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ketty MD Peris
  phone: 0630154211
  email: ketty.peris@unicatt.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema
  mesh term: Upadacitinib
  sharing ipd: Undecided