<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/NCT03824561</url>
  </required_header>
  <id_info>
    <org_study_id>Vedolizumab-5033</org_study_id>
    <secondary_id>jRCT1080224534</secondary_id>
    <nct_id>NCT03824561</nct_id>
  </id_info>
  <brief_title>Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]</brief_title>
  <official_title>Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this survey is to evaluate the long-term safety and effectiveness of&#xD;
      vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC)&#xD;
      patients in the routine clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug&#xD;
      is being tested to treat patients who have UC.&#xD;
&#xD;
      This survey is an observational (non-interventional) study and will look at the long-term&#xD;
      safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical&#xD;
      setting. The planned number of observed patients will be approximately 1,000.&#xD;
&#xD;
      This multi-center observational trial will be conducted in Japan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2024</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>Number of Participants who have One or More Adverse Events</measure>
    <time_frame>Up to Week 54</time_frame>
    <description>Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants who have One or More Adverse Drug Reactions</measure>
    <time_frame>Up to Week 54</time_frame>
    <description>AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants who have a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab</measure>
    <time_frame>After 3 doses of vedolizumab (Week 6 to 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants who continue the Therapy After 3 Doses of Vedolizumab</measure>
    <time_frame>After 3 doses of vedolizumab (Week 6 to 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Complete Mayo Scores</measure>
    <time_frame>Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54</time_frame>
    <description>Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Complete Mayo score sums 4 sub-scores and ranges from 0 to 12, with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Partial Mayo Scores</measure>
    <time_frame>Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54</time_frame>
    <description>Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Partial Mayo score sums 3 sub-scores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)</measure>
    <time_frame>Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54</time_frame>
    <description>The SIBDQ is an instrument used to assess quality of life and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score will be reported and is ranging from 10 to 70 with a higher score indicates a better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Fecal Calprotectin</measure>
    <time_frame>Baseline and multiple time points up to Week 54</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1096</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Vedolizumab 300 mg</arm_group_label>
    <description>Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vedolizumab</intervention_name>
    <description>Vedolizumab IV infusion</description>
    <arm_group_label>Vedolizumab 300 mg</arm_group_label>
    <other_name>Entyvio for IV Infusion 300 mg</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        UC patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have moderate or severe active UC&#xD;
&#xD;
          2. Have inadequate response to existing therapies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with any contraindication for vedolizumab&#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>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Takeda Selected Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b603a4db2bf003ab4a2c9</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vedolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </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/NCT03824561
org study id: Vedolizumab-5033
secondary id: jRCT1080224534
nct id: NCT03824561
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this survey is to evaluate the long-term safety and effectiveness of
      vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC)
      patients in the routine clinical setting.
The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug
      is being tested to treat patients who have UC.

      This survey is an observational (non-interventional) study and will look at the long-term
      safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical
      setting. The planned number of observed patients will be approximately 1,000.

      This multi-center observational trial will be conducted in Japan.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants who have One or More Adverse Events
time frame: Up to Week 54
description: Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
measure: Number of Participants who have One or More Adverse Drug Reactions
time frame: Up to Week 54
description: AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
measure: Number of Participants who have a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
time frame: After 3 doses of vedolizumab (Week 6 to 14)
measure: Number of Participants who continue the Therapy After 3 Doses of Vedolizumab
time frame: After 3 doses of vedolizumab (Week 6 to 14)
measure: Change from Baseline in Complete Mayo Scores
time frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54
description: Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Complete Mayo score sums 4 sub-scores and ranges from 0 to 12, with higher scores indicating more severe disease.
measure: Change from Baseline in Partial Mayo Scores
time frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54
description: Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Partial Mayo score sums 3 sub-scores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease.
measure: Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
time frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54
description: The SIBDQ is an instrument used to assess quality of life and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score will be reported and is ranging from 10 to 70 with a higher score indicates a better health-related quality of life.
measure: Change from Baseline in Fecal Calprotectin
time frame: Baseline and multiple time points up to Week 54
arm group label: Vedolizumab 300 mg
description: Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.
intervention type: Drug
intervention name: Vedolizumab
description: Vedolizumab IV infusion
arm group label: Vedolizumab 300 mg
other name: Entyvio for IV Infusion 300 mg
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
country: Japan
url: https://clinicaltrials.takeda.com/study-detail/5f6b603a4db2bf003ab4a2c9
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Vedolizumab
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/