<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/NCT02986724</url>
  </required_header>
  <id_info>
    <org_study_id>Vedolizumab-4017</org_study_id>
    <nct_id>NCT02986724</nct_id>
  </id_info>
  <brief_title>A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD)</brief_title>
  <acronym>CHRONOS</acronym>
  <official_title>CHRONOS - A Multicenter, Non - Interventional Study to Observe the Safety and Efficacy of Vedolizumab (Entyvio) in Patients With Ulcerative Colitis or Crohn´s Disease That Are Biologic naïve, Observed in Daily Practice in Austria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this non-interventional study (NIS) study is to assess further knowledge on&#xD;
      the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in&#xD;
      participants with CD and UC naive to biologics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this prospective, observational study is called vedolizumab.&#xD;
      Vedolizumab (Entyvio) is being used to treat people who have CD or UC. This study will look&#xD;
      in the routine use of vedolizumab in inflammatory bowel disease therapy in participants with&#xD;
      CD or UC who did not receive a biologic treatment before. The study will enroll approximately&#xD;
      150 participants. All participants enrolled in this will belong to one observational group:&#xD;
      Vedolizumab.&#xD;
&#xD;
      Participants taking vedolizumab as per physician's prescription in routine clinical practice&#xD;
      will be observed.&#xD;
&#xD;
      This multi-centre trial will be conducted in Austria. The overall time to participate in this&#xD;
      study is 2 years. Participant taking vedolizumab in routine clinical practice will make&#xD;
      multiple visits to the clinic at Baseline, Week 20 and 52. Once a participant is switched to&#xD;
      subsequent biologic treatment upon failing treatment with vedolizumab, the switching date&#xD;
      will be considered as new baseline followed by visits at Week 20 and 52.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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>Percentage of Participants With UC Achieving Clinical Response Based on Partial Mayo Score</measure>
    <time_frame>Baseline up to 52 Weeks</time_frame>
    <description>Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and &gt;=25% from baseline, with an accompanying decrease in rectal bleeding subscore of &gt;=1 point from baseline or absolute rectal bleeding subscore of &lt;=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in bio-naive participants who receive vedolizumab treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With CD Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)</measure>
    <time_frame>Baseline up to 52 Weeks</time_frame>
    <description>Clinical response is defined as a decrease in HBI score of &gt;=3 points from baseline. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Bio-naïve Participants Reporting One or More Treatment-emergent Adverse Events</measure>
    <time_frame>Baseline up to 52 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score</measure>
    <time_frame>up to 52 weeks from start of another biological therapy</time_frame>
    <description>Clinical remission is defined as a partial Mayo score of &lt;=2 with no individual subscore &gt;1. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CD Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI)</measure>
    <time_frame>up to 52 weeks from start of another biological therapy</time_frame>
    <description>Clinical remission is defined as total HBI score of &lt;=4 points. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With UC Achieving Durable Clinical Response Based on Partial Mayo Score</measure>
    <time_frame>up to 52 weeks from start of another biological therapy</time_frame>
    <description>Durable clinical response is defined as clinical response at Week 104, where clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and &gt;=25% from baseline, with an accompanying decrease in rectal bleeding subscore of &gt;=1 point from baseline or absolute rectal bleeding subscore of &lt;=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CD Achieving Durable Clinical Response Based on Harvey-Bradshaw Index (HBI)</measure>
    <time_frame>up to 52 weeks from start of another biological therapy</time_frame>
    <description>Durable clinical response is defined as clinical response at Week 104, where clinical response is defined as a decrease in HBI score of &gt;=3 points from baseline. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants who Failed Vedolizumab Therapy Reporting One or More Treatment-emergent Adverse Events</measure>
    <time_frame>up to 52 weeks from start of another biological therapy</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Crohn Disease</condition>
  <condition>Colitis, Ulcerative</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Vedolizumab</arm_group_label>
    <description>Bio-naïve participants with UC or CD will be treated with vedolizumab as per local prescriptions from physician in routine medical practice for up to 52 Week. Participants who fail on vedolizumab may be switched during the study to another biologic treatment as prescribed by the physician during routine medical practice for up to 52 Weeks.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Biologically naïve participants with UC or CD undergoing treatment with Vedolizumab&#xD;
        (Entyvio) will be evaluated for safety and efficacy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        1 Initiating vedolizumab for moderately to severely active UC or CD. Exclusion Criteria&#xD;
&#xD;
          1. Participant is enrolled in a clinical trial in which treatment for UC or CD is managed&#xD;
             through a protocol,&#xD;
&#xD;
          2. Prior treatment with a biologic agent,&#xD;
&#xD;
          3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable&#xD;
             to participate in this 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_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>September 23, 2020</last_update_submitted>
  <last_update_submitted_qc>September 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</ipd_description>
  </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/NCT02986724
org study id: Vedolizumab-4017
nct id: NCT02986724
lead sponsor: 
has dmc: No
The purpose of this non-interventional study (NIS) study is to assess further knowledge on
      the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in
      participants with CD and UC naive to biologics.
The drug being tested in this prospective, observational study is called vedolizumab.
      Vedolizumab (Entyvio) is being used to treat people who have CD or UC. This study will look
      in the routine use of vedolizumab in inflammatory bowel disease therapy in participants with
      CD or UC who did not receive a biologic treatment before. The study will enroll approximately
      150 participants. All participants enrolled in this will belong to one observational group:
      Vedolizumab.

      Participants taking vedolizumab as per physician's prescription in routine clinical practice
      will be observed.

      This multi-centre trial will be conducted in Austria. The overall time to participate in this
      study is 2 years. Participant taking vedolizumab in routine clinical practice will make
      multiple visits to the clinic at Baseline, Week 20 and 52. Once a participant is switched to
      subsequent biologic treatment upon failing treatment with vedolizumab, the switching date
      will be considered as new baseline followed by visits at Week 20 and 52.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With UC Achieving Clinical Response Based on Partial Mayo Score
time frame: Baseline up to 52 Weeks
description: Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and >=25% from baseline, with an accompanying decrease in rectal bleeding subscore of >=1 point from baseline or absolute rectal bleeding subscore of <=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in bio-naive participants who receive vedolizumab treatment.
measure: Percentage of Participants With CD Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)
time frame: Baseline up to 52 Weeks
description: Clinical response is defined as a decrease in HBI score of >=3 points from baseline. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.
measure: Number of Bio-naïve Participants Reporting One or More Treatment-emergent Adverse Events
time frame: Baseline up to 52 Weeks
measure: Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score
time frame: up to 52 weeks from start of another biological therapy
description: Clinical remission is defined as a partial Mayo score of <=2 with no individual subscore >1. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
measure: Percentage of Participants With CD Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI)
time frame: up to 52 weeks from start of another biological therapy
description: Clinical remission is defined as total HBI score of <=4 points. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
measure: Percentage of Participants With UC Achieving Durable Clinical Response Based on Partial Mayo Score
time frame: up to 52 weeks from start of another biological therapy
description: Durable clinical response is defined as clinical response at Week 104, where clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and >=25% from baseline, with an accompanying decrease in rectal bleeding subscore of >=1 point from baseline or absolute rectal bleeding subscore of <=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
measure: Percentage of Participants With CD Achieving Durable Clinical Response Based on Harvey-Bradshaw Index (HBI)
time frame: up to 52 weeks from start of another biological therapy
description: Durable clinical response is defined as clinical response at Week 104, where clinical response is defined as a decrease in HBI score of >=3 points from baseline. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease. Outcome measure is planned to be assessed in participants who failed on vedolizumab during the first 52 weeks and will switch to another biological therapy up to 52 weeks.
measure: Number of Participants who Failed Vedolizumab Therapy Reporting One or More Treatment-emergent Adverse Events
time frame: up to 52 weeks from start of another biological therapy
arm group label: Vedolizumab
description: Bio-naïve participants with UC or CD will be treated with vedolizumab as per local prescriptions from physician in routine medical practice for up to 52 Week. Participants who fail on vedolizumab may be switched during the study to another biologic treatment as prescribed by the physician during routine medical practice for up to 52 Weeks.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Takeda
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Inflammatory Bowel Diseases
mesh term: Ulcer
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.