<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/NCT02193048</url>
  </required_header>
  <id_info>
    <org_study_id>000150</org_study_id>
    <nct_id>NCT02193048</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease</brief_title>
  <acronym>PROGNOS</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to prospectively evaluate a scoring system to predict a mild&#xD;
      course of disease in patients newly diagnosed with Crohn's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Evaluation of a Crohn's scoring system</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Measured as percentage of patients with a low score at initial diagnosis having a mild course of disease during the 5 year follow-up period.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">216</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Patients newly diagnosed with Crohn's disease</arm_group_label>
    <description>This study will evaluate a new clinical scoring system in patients receiving routine treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>This study will evaluate a new clinical scoring system in patients receiving routine treatment</intervention_name>
    <description>Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.</description>
    <arm_group_label>Patients newly diagnosed with Crohn's disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Specialist gastroenterological centres&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients with Crohn's disease who&#xD;
&#xD;
          -  have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and&#xD;
&#xD;
          -  are as yet untreated (permitted medications are a maximum of 10 days of&#xD;
             5-aminosalicylates (5-ASA) or glucocorticosteroids and antibiotics for non-intestinal&#xD;
             indications) and&#xD;
&#xD;
          -  have consented to the documentation of their patient data and&#xD;
&#xD;
          -  agree to the up to 5-year documentation of the course of disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-treatment with 5-ASA &gt; 10 days&#xD;
&#xD;
          -  Treatment with steroids &gt; 10 days&#xD;
&#xD;
          -  Treatment with antibiotics, immunosuppressants or biological agents &gt; 10 days&#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>Global Clinical Compliance</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational site (there may be other sites in this country)</name>
      <address>
        <city>Altenholz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</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>Crohn Disease</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/NCT02193048
org study id: 000150
nct id: NCT02193048
lead sponsor: 
The purpose of this study is to prospectively evaluate a scoring system to predict a mild
      course of disease in patients newly diagnosed with Crohn's disease.
observational model: Case-Only
time perspective: Prospective
measure: Evaluation of a Crohn's scoring system
time frame: Up to 5 years
description: Measured as percentage of patients with a low score at initial diagnosis having a mild course of disease during the 5 year follow-up period.
arm group label: Patients newly diagnosed with Crohn's disease
description: This study will evaluate a new clinical scoring system in patients receiving routine treatment
intervention type: Other
intervention name: This study will evaluate a new clinical scoring system in patients receiving routine treatment
description: Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.
arm group label: Patients newly diagnosed with Crohn's disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Compliance
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Crohn Disease