<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/NCT01661387</url>
  </required_header>
  <id_info>
    <org_study_id>0918-400</org_study_id>
    <nct_id>NCT01661387</nct_id>
  </id_info>
  <brief_title>A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)</brief_title>
  <official_title>A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As a post-approval requirement of the European Medicines Agency, this European patient post&#xD;
      authorization safety study is an observational study being conducted to monitor the safety of&#xD;
      long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine&#xD;
      clinical practice in patients with chronic adrenal insufficiency (primary or secondary).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Takeda submitted 900 patient years Interim Analysis to PRAC and requested study to be closed&#xD;
    since primary objective had been fulfilled. PRAC agreed and on 17Sep2020 approved closure of&#xD;
    EU-AIR Registry. Takeda announced study closure on 31Oct2020.&#xD;
  </why_stopped>
  <start_date type="Actual">August 7, 2012</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of intercurrent illness</measure>
    <time_frame>approximately 10 years</time_frame>
    <description>Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adrenal crisis</measure>
    <time_frame>approximately 10 years</time_frame>
    <description>Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of serious adverse events</measure>
    <time_frame>approximately 10 years</time_frame>
    <description>Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3258</enrollment>
  <condition>Chronic Adrenal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Plenadren</arm_group_label>
    <description>Modified release hydrocortisone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other Glucocorticoid Replacement Therapy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic adrenal insufficiency (primary or secondary) who are receiving&#xD;
        Plenadren or other glucocorticoid replacement therapies at endocrinology centres in certain&#xD;
        European countries as part of their routine clinical care. Approximately 20 sites are&#xD;
        planned for enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic adrenal insufficiency&#xD;
&#xD;
          -  Written informed consent/assent in compliance with applicable country-specific and&#xD;
             local regulations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in an interventional clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shire Director</last_name>
    <role>Study Director</role>
    <affiliation>Shire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endokrinologiepraxis am Stuttgarter Platz</name>
      <address>
        <city>Berlin</city>
        <zip>10627</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Friedrich Alexander Universitat Erlangen Nurnberg</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU Klinikum der Universität München</name>
      <address>
        <city>Munchen</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicover Neuroendokrinologie</name>
      <address>
        <city>Munchen</city>
        <zip>81667</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicover Oldenburg MVZ</name>
      <address>
        <city>Oldenburg</city>
        <zip>26122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endokrinologiezentrum Ulm Praxis</name>
      <address>
        <city>Ulm</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Wuerzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi Federico II</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3051</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Universitetssjukhuset</name>
      <address>
        <city>Gothenborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitetssjukhuset i Linköping</name>
      <address>
        <city>Linkoping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James University Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts and The London NHS Trust</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adrenal insufficiency</keyword>
  <keyword>DuoCort</keyword>
  <keyword>Congenital adrenal hyperplasia (CAH)</keyword>
  <keyword>Modified release</keyword>
  <keyword>Hydrocortisone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenal Insufficiency</mesh_term>
  </condition_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/NCT01661387
org study id: 0918-400
nct id: NCT01661387
lead sponsor: 
has dmc: No
As a post-approval requirement of the European Medicines Agency, this European patient post
      authorization safety study is an observational study being conducted to monitor the safety of
      long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine
      clinical practice in patients with chronic adrenal insufficiency (primary or secondary).
observational model: Case-Only
time perspective: Prospective
measure: Incidence of intercurrent illness
time frame: approximately 10 years
description: Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
measure: Incidence of adrenal crisis
time frame: approximately 10 years
description: Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
measure: Incidence of serious adverse events
time frame: approximately 10 years
description: Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
arm group label: Plenadren
description: Modified release hydrocortisone
arm group label: Other Glucocorticoid Replacement Therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shire Director
role: Study Director
affiliation: Shire
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country: Germany
country: Italy
country: Netherlands
country: Sweden
country: United Kingdom
responsible party type: Sponsor
mesh term: Adrenal Insufficiency