<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/NCT03029143</url>
  </required_header>
  <id_info>
    <org_study_id>Vedolizumab-4014</org_study_id>
    <secondary_id>U1111-1183-0451</secondary_id>
    <nct_id>NCT03029143</nct_id>
  </id_info>
  <brief_title>Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis</brief_title>
  <acronym>ENTERPRET</acronym>
  <official_title>A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET)</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy and safety of vedolizumab&#xD;
      intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab&#xD;
      IV dosing regimen over a 30 week treatment period in participants with moderately to severely&#xD;
      active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined&#xD;
      serum vedolizumab concentration threshold less than (&lt;) 50 microgram per milliliter&#xD;
      (microg/mL) and who are Week 6 non-responders based on partial Mayo score.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered&#xD;
      as an IV infusion. It is being tested in this study with new doses. This study will&#xD;
      investigate the efficacy and safety of dose optimization of vedolizumab IV, compared with&#xD;
      standard dosing of vedolizumab IV, over a 30-week treatment period.&#xD;
&#xD;
      The study will enroll approximately 250 moderately to severely active subjects with UC in&#xD;
      order to randomize approximately 100 non-responder subjects with high vedolizumab drug&#xD;
      clearance. Subjects will receive induction therapy of vedolizumab IV 300 mg on Day 1 and Week&#xD;
      2 (Lead-in Period). At Week 5, serum vedolizumab concentration will be measured. At Week 6,&#xD;
      subjects will be assessed for clinical response based on partial Mayo score.&#xD;
&#xD;
      Results of both Week 5 vedolizumab concentration and Week 6 clinical response will determine&#xD;
      the treatment pathway. Those who are non-responders based on partial Mayo score at Week 6 and&#xD;
      who are assessed as having high vedolizumab clearance, based on a predefined Week 5 serum&#xD;
      vedolizumab concentration threshold (&lt;50 microg/mL) will be randomly assigned (by chance,&#xD;
      like flipping a coin) to one of the two treatment groups:&#xD;
&#xD;
        -  Vedolizumab IV Standard Treatment&#xD;
&#xD;
        -  Vedolizumab IV Dose Optimized&#xD;
&#xD;
      All randomized subjects will receive vedolizumab IV either 300 mg or 600 mg every 4 or 8&#xD;
      weeks.&#xD;
&#xD;
      This multi-center trial will be conducted in United States of America and Canada. The overall&#xD;
      time to participate in this study is 56 weeks. Subjects will make multiple visits to the&#xD;
      clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long&#xD;
      term follow-up safety survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Actual">October 16, 2020</completion_date>
  <primary_completion_date type="Actual">October 16, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Mucosal Healing at Week 30</measure>
    <time_frame>Week 30</time_frame>
    <description>Mucosal healing is defined as Mayo endoscopic subscore &lt;=1 point. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinical Remission at Week 30</measure>
    <time_frame>Week 30</time_frame>
    <description>Clinical remission is defined as a complete Mayo score of ≤2 points and no individual subscore &gt;1 point at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinical Response at Week 30</measure>
    <time_frame>Week 30</time_frame>
    <description>Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point, at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinical Response at Week 14</measure>
    <time_frame>Week 14</time_frame>
    <description>Clinical response is defined as A reduction in partial Mayo score of ≥2 points and ≥25% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Corticosteroid-Free Remission</measure>
    <time_frame>Week 30</time_frame>
    <description>Participants using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission. Mayo score was used in clinical trials to assess UC disease activity. Clinical Remission is defined as a complete Mayo score of &lt;=2 points and no individual subscore &gt;1 point at Week 30. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Durable Clinical Response</measure>
    <time_frame>Weeks 14 and 30</time_frame>
    <description>A clinical response (based on partial Mayo score), which is defined as a reduction in partial Mayo score of ≥2 points and ≥25% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Weeks 14 and 30. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore. Percentage of participants with durable clinical response, clinical response achieved at both Weeks 14 and 30 are reported.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">278</enrollment>
  <condition>Colitis, Ulcerative</condition>
  <arm_group>
    <arm_group_label>Lead-in Period: Vedolizumab 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2. Participants who were non-responders based on partial Mayo score at Week 6 and who had high vedolizumab clearance (&gt;0.14 L/day) at Week 5 were eligible for Randomized Treatment Period (RTP). Participants who were responders (Lead-In Failures) entered the 18-week follow-up period and discontinued the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomized Treatment Period (RTP): Standard Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) at Weeks 6, 14 and 22 as standard treatment plus 18 weeks follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RTP: Dose Optimized Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following Lead-in Period, participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vedolizumab IV</intervention_name>
    <description>Vedolizumab intravenous infusion.</description>
    <arm_group_label>Lead-in Period: Vedolizumab 300 mg</arm_group_label>
    <arm_group_label>RTP: Dose Optimized Arm</arm_group_label>
    <arm_group_label>Randomized Treatment Period (RTP): Standard Treatment Arm</arm_group_label>
    <other_name>Entyvio</other_name>
    <other_name>MLN0002</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has a diagnosis of UC established at least 1 month prior to Screening by clinical and&#xD;
             endoscopic evidence and corroborated by a histopathology report.&#xD;
&#xD;
          2. Has moderately to severely active UC as determined by a complete Mayo score of 6 to 12&#xD;
             with an endoscopic subscore ≥2 within 28 days prior to enrollment.&#xD;
&#xD;
          3. Has evidence of UC proximal to the rectum (≥15 cm of involved colon) prior to start of&#xD;
             vedolizumab IV dosing.&#xD;
&#xD;
          4. Has been determined to be suitable for vedolizumab IV for routine management of UC by&#xD;
             their physician.&#xD;
&#xD;
          5. Has a family history of colorectal cancer, personal history of increased colorectal&#xD;
             cancer risk, age &gt;50 years, or other known risk factor must be up-to-date on&#xD;
             colorectal cancer surveillance (may be performed during screening).&#xD;
&#xD;
          6. Has demonstrated an inadequate response with, lost response to, or intolerance of at&#xD;
             least 1 of the following agents: immunomodulators, corticosteroids, or tumor necrosis&#xD;
             factor-alpha (TNF-α) antagonists. Subject who are naive to TNF-α antagonist therapy or&#xD;
             who have previously failed TNF-α antagonist therapy (including primary and secondary&#xD;
             non-responders or intolerant) may be included.&#xD;
&#xD;
             Week 6 Randomized Treatment Period Inclusion Criteria&#xD;
&#xD;
          7. Following Lead-in Period, the subject is assessed as having high vedolizumab drug&#xD;
             clearance based on a predefined Week 5 serum vedolizumab concentration threshold (&lt;50&#xD;
             microg/mL).&#xD;
&#xD;
          8. Following Lead-in Period, the subject is a non-responder based on partial Mayo score&#xD;
             at Week 6.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has clinical evidence of abdominal abscess or toxic megacolon at the Screening Visit.&#xD;
&#xD;
          2. Has had an extensive colonic resection, subtotal or total colectomy.&#xD;
&#xD;
          3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.&#xD;
&#xD;
          4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis,&#xD;
             radiation colitis, diverticular disease associated with colitis, or microscopic&#xD;
             colitis.&#xD;
&#xD;
          5. Has received any of the following for the treatment of underlying disease within 30&#xD;
             days of screening:&#xD;
&#xD;
               1. Non-biologic therapies (eg. cyclosporine, tacrolimus, thalidomide)&#xD;
&#xD;
               2. An approved non-biologic therapy in an investigational protocol.&#xD;
&#xD;
          6. Has received any investigational or approved biologic or biosimilar agent within 60&#xD;
             days or 5 half-lives prior to screening (whichever is longer).&#xD;
&#xD;
          7. Has previously had prior exposure to approved or investigational anti-integrin&#xD;
             antibodies (e.g. natalizumab, efalizumab, etrolizumab, AMG-181, anti-MAdCAM-1&#xD;
             antibodies or rituximab).&#xD;
&#xD;
          8. Has previously received approved or investigational vedolizumab.&#xD;
&#xD;
          9. The subject currently requires or is anticipated to require surgical intervention for&#xD;
             UC during the study.&#xD;
&#xD;
         10. Has history or evidence of adenomatous colonic polyps that have not been removed, or&#xD;
             colonic mucosal dysplasia.&#xD;
&#xD;
         11. Has any evidence of an active infection during Screening (eg, sepsis, cytomegalovirus,&#xD;
             or listeriosis).&#xD;
&#xD;
         12. Has a clinically significant infection (eg, pneumonia, pyelonephritis) within 30 days&#xD;
             prior to screening, or ongoing chronic infection.&#xD;
&#xD;
         13. Has evidence of active C. difficile as evidenced by positive C. difficile toxin or is&#xD;
             having treatment for C. difficile infection or other intestinal pathogens during&#xD;
             Screening.&#xD;
&#xD;
         14. Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B&#xD;
             (HBV), or chronic HBV (HBV immune subjects (ie, being hepatitis B surface antigen&#xD;
             [HBsAg] negative and hepatitis B antibody positive) may, however, be included), or&#xD;
             hepatitis C virus (HCV) infection. Subjects with documented successful treatment of&#xD;
             HCV with sustained virological response (SVR) at 26 weeks can be enrolled.&#xD;
&#xD;
         15. Has active or latent tuberculosis (TB), as evidenced by the following:&#xD;
&#xD;
             a. A diagnostic TB test performed within 30 days of screening or during the Screening&#xD;
             Period that is positive, defined as: i. Positive QuantiFERON test or 2 successive&#xD;
             indeterminate QuantiFERON tests, OR ii. A TB skin test reaction ≥ 5 mm OR, b. Chest&#xD;
             X-ray within 3 months of screening that is suspicious for pulmonary TB, and a positive&#xD;
             or 2 successive indeterminate QuantiFERON tests within 30 days prior to Screening or&#xD;
             during the Screening Period.&#xD;
&#xD;
         16. Has any identified congenital or acquired immunodeficiency (eg, common variable&#xD;
             immunodeficiency, HIV infection, organ transplantation).&#xD;
&#xD;
         17. Has any live vaccination within 30 days prior to Screening or is planning to receive&#xD;
             any live vaccination during participation in the study.&#xD;
&#xD;
         18. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid&#xD;
             enemas/suppositories within 2 weeks prior to Screening.&#xD;
&#xD;
         19. Has a history of hypersensitivity or allergies to vedolizumab IV or its components.&#xD;
&#xD;
         20. Has received total parenteral nutrition (TPN) or albumin in the last 30 days prior to&#xD;
             screening.&#xD;
&#xD;
         21. Has any unstable or uncontrolled cardiovascular disorder, heart failure moderate to&#xD;
             severe (New York Class Association III or IV), any pulmonary, hepatic, renal, GI,&#xD;
             genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or&#xD;
             other medical disorder that, in the opinion of the investigator, would confound the&#xD;
             study results or compromise subject safety.&#xD;
&#xD;
         22. Has had a surgical procedure requiring general anesthesia within 30 days prior to&#xD;
             screening or is planning to undergo major surgery during the study period.&#xD;
&#xD;
         23. Has a history of malignancy, except for the following: adequately-treated&#xD;
             non-metastatic basal cell skin cancer; squamous cell skin cancer that has been&#xD;
             adequately treated and that has not recurred for at least 1 year prior to Screening;&#xD;
             and history of cervical carcinoma in situ that has been adequately treated and that&#xD;
             has not recurred for at least 3 years prior to screening. Subjects with remote history&#xD;
             of malignancy (eg, &gt;10 years since completion of curative therapy without recurrence)&#xD;
             will be considered based on the nature of the malignancy and the therapy received and&#xD;
             must be discussed with the sponsor on a case by-case basis prior to Screening.&#xD;
&#xD;
         24. Has a history of any major neurological disorders, including stroke, multiple&#xD;
             sclerosis, brain tumor, demyelinating, or neurodegenerative disease.&#xD;
&#xD;
         25. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom&#xD;
             checklist during Screening or prior to the administration of the first dose of study&#xD;
             drug on Day 1.&#xD;
&#xD;
         26. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol&#xD;
             abuse within 1 year prior to the Screening Visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Clinical Therapeutics, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Primary Care Clinic, PA</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research LLC</name>
      <address>
        <city>San Pablo</city>
        <state>California</state>
        <zip>94806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research, San Pablo</name>
      <address>
        <city>San Pablo</city>
        <state>California</state>
        <zip>94806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Fairfield County</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Network, LLC</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellness Clinical Research, LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Advanced Gastro</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Interventional Endo</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BRCR Medical Center, Inc.</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Specialists, PC</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Gastroenterology</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Teton Research Group, PLLC</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aquiant Research</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Digestive disease center</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton O'Neil Clinical Research Center</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates LLC</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Research Center, LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>4940 Eastern Ave A building</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Center of Maryland</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>20721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodholme Gastroenterology Associates</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Medical Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Gastroenterology and Hepatology</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Gastroenterology, Inc</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates PA</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Medical Care</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants - Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ygenics</name>
      <address>
        <city>Decatur</city>
        <state>Texas</state>
        <zip>76234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants</name>
      <address>
        <city>Keller</city>
        <state>Texas</state>
        <zip>76248</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DHAT Research Institute</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants - Southlake</name>
      <address>
        <city>Southlake</city>
        <state>Texas</state>
        <zip>76092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BaylorScott&amp;White Research Institute</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Liver Research LLC</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Northern Virginia, Ltd.</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin, Inc.</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PerCuro Clinical Research Ltd.</name>
      <address>
        <city>Victoria</city>
        <state>British Colombia</state>
        <zip>V8V 3M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LHSC - University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LHSC - Victoria Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taunton Surgical Centre</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1H 7K4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Digestive Disease Associates, Inc.</name>
      <address>
        <city>Vaughan</city>
        <state>Ontario</state>
        <zip>L4L4Y7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b60394db2bf003ab4a241?idFilter=%5B%22Vedolizumab-4014%22%5D</url>
    <description>To obtain more information on the study, click on this link</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>October 15, 2021</results_first_submitted>
  <results_first_submitted_qc>October 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 11, 2021</results_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</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>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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03029143/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03029143/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants with ulcerative colitis (UC) took part in the study at 90 investigative sites in the United States and Canada from 29 March 2017 to 16 October 2020.</recruitment_details>
      <pre_assignment_details>Participants with UC enrolled in Lead-in Period received vedolizumab 300 mg at Day 1 and Week 2. At Week 5, participants were assessed for clearance and at Week 6 for clinical response per partial Mayo Score. The non-responders were randomized to receive optimized treatment (Regimen A or B, dose decided by vedolizumab clearance) or standard vedolizumab treatment. The responders or participants with low vedolizumab clearance received vedolizumab 300 mg at Week 6 plus 18-week follow-up.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lead-in Period: Vedolizumab 300 mg</title>
          <description>Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2. Participants were then assessed to estimate the vedolizumab clearance at Week 5 and response at Week 6.</description>
        </group>
        <group group_id="P2">
          <title>Randomized Treatment Period (RTP): Standard Treatment Arm</title>
          <description>Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) at Weeks 6, 14 and 22 as standard treatment plus 18 weeks follow-up.</description>
        </group>
        <group group_id="P3">
          <title>RTP: Dose Optimized Arm</title>
          <description>Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Lead-in Period (6 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="169"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pretreatment Event/Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Significant Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Voluntary Withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not Treated</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Randomized Treatment Period (24 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Not Treated Post Randomization</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1">One participant was randomized to Randomized Treatment Period: Standard Treatment Arm, but was not treated and was thus included in the Lead-in failure vedolizumab arm for the Safety Analysis Set (N=170).</participants>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="55">Regimen A = 28 Regimen B = 27</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pretreatment Event/Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Significant Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Voluntary Withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set Included all participants who were enrolled and received at least one dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Lead-in Period: Vedolizumab 300 mg</title>
          <description>Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2 . Participants were then assessed to estimate the vedolizumab clearance at Week 5 and response at Week 6.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="278"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.9" spread="15.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="244"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="228"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171.5" spread="9.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.41" spread="20.112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>BMI=weight (kg)/[height (m)^2].</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.24" spread="5.942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Classification</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participant has never smoked</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant is a current smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant is an ex-smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Mucosal Healing at Week 30</title>
        <description>Mucosal healing is defined as Mayo endoscopic subscore &lt;=1 point. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
        <time_frame>Week 30</time_frame>
        <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>RTP: Standard Treatment Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.</description>
          </group>
          <group group_id="O2">
            <title>RTP: Dose Optimized Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Mucosal Healing at Week 30</title>
          <description>Mucosal healing is defined as Mayo endoscopic subscore &lt;=1 point. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
          <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" lower_limit="9.4" upper_limit="32.0"/>
                    <measurement group_id="O2" value="14.5" lower_limit="6.5" upper_limit="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.401</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
            <other_analysis_desc>Chi-squared test was used to estimate P-value from the logistic regression model where Endoscopic Mucosal Healing was the response variable and Treatment and TNF stratification were factors. Baseline complete Mayo Score and natural logarithm of trough concentration at week 6 were covariates.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinical Remission at Week 30</title>
        <description>Clinical remission is defined as a complete Mayo score of ≤2 points and no individual subscore &gt;1 point at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
        <time_frame>Week 30</time_frame>
        <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>RTP: Standard Treatment Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.</description>
          </group>
          <group group_id="O2">
            <title>RTP: Dose Optimized Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Remission at Week 30</title>
          <description>Clinical remission is defined as a complete Mayo score of ≤2 points and no individual subscore &gt;1 point at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
          <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="3.1" upper_limit="20.7"/>
                    <measurement group_id="O2" value="9.1" lower_limit="3.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.943</p_value>
            <method>CMH Chi-square test</method>
            <param_type>Adjusted risk difference</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.4</ci_lower_limit>
            <ci_upper_limit>10.6</ci_upper_limit>
            <other_analysis_desc>Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinical Response at Week 30</title>
        <description>Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point, at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
        <time_frame>Week 30</time_frame>
        <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>RTP: Standard Treatment Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.</description>
          </group>
          <group group_id="O2">
            <title>RTP: Dose Optimized Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Response at Week 30</title>
          <description>Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point, at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
          <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
          <units>percentage of particpants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.1" lower_limit="19.9" upper_limit="46.3"/>
                    <measurement group_id="O2" value="30.9" lower_limit="19.1" upper_limit="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.893</p_value>
            <method>CMH Chi-square test</method>
            <param_type>Adjusted risk difference</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.7</ci_lower_limit>
            <ci_upper_limit>16.3</ci_upper_limit>
            <other_analysis_desc>Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinical Response at Week 14</title>
        <description>Clinical response is defined as A reduction in partial Mayo score of ≥2 points and ≥25% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore.</description>
        <time_frame>Week 14</time_frame>
        <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>RTP: Standard Treatment Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.</description>
          </group>
          <group group_id="O2">
            <title>RTP: Dose Optimized Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Response at Week 14</title>
          <description>Clinical response is defined as A reduction in partial Mayo score of ≥2 points and ≥25% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore.</description>
          <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" lower_limit="21.5" upper_limit="48.3"/>
                    <measurement group_id="O2" value="40.0" lower_limit="27.0" upper_limit="54.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.525</p_value>
            <method>CMH Chi-square test</method>
            <param_type>Adjusted risk difference</param_type>
            <param_value>6.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.4</ci_lower_limit>
            <ci_upper_limit>24.3</ci_upper_limit>
            <other_analysis_desc>Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Corticosteroid-Free Remission</title>
        <description>Participants using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission. Mayo score was used in clinical trials to assess UC disease activity. Clinical Remission is defined as a complete Mayo score of &lt;=2 points and no individual subscore &gt;1 point at Week 30. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
        <time_frame>Week 30</time_frame>
        <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization. Overall number analyzed are the participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>RTP: Standard Treatment Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.</description>
          </group>
          <group group_id="O2">
            <title>RTP: Dose Optimized Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Corticosteroid-Free Remission</title>
          <description>Participants using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission. Mayo score was used in clinical trials to assess UC disease activity. Clinical Remission is defined as a complete Mayo score of &lt;=2 points and no individual subscore &gt;1 point at Week 30. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.</description>
          <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization. Overall number analyzed are the participants with data available for analyses.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="4.7" upper_limit="50.8"/>
                    <measurement group_id="O2" value="14.3" lower_limit="3.0" upper_limit="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.623</p_value>
            <method>CMH Chi-square test</method>
            <param_type>Adjusted risk difference</param_type>
            <param_value>-6.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.0</ci_lower_limit>
            <ci_upper_limit>20.8</ci_upper_limit>
            <other_analysis_desc>Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Durable Clinical Response</title>
        <description>A clinical response (based on partial Mayo score), which is defined as a reduction in partial Mayo score of ≥2 points and ≥25% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Weeks 14 and 30. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore. Percentage of participants with durable clinical response, clinical response achieved at both Weeks 14 and 30 are reported.</description>
        <time_frame>Weeks 14 and 30</time_frame>
        <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>RTP: Standard Treatment Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.</description>
          </group>
          <group group_id="O2">
            <title>RTP: Dose Optimized Arm</title>
            <description>Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Durable Clinical Response</title>
          <description>A clinical response (based on partial Mayo score), which is defined as a reduction in partial Mayo score of ≥2 points and ≥25% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Weeks 14 and 30. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore. Percentage of participants with durable clinical response, clinical response achieved at both Weeks 14 and 30 are reported.</description>
          <population>Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" lower_limit="12.3" upper_limit="36.2"/>
                    <measurement group_id="O2" value="30.9" lower_limit="19.1" upper_limit="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.344</p_value>
            <method>CMH Chi-square test</method>
            <param_type>Adjusted risk difference</param_type>
            <param_value>8.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.5</ci_lower_limit>
            <ci_upper_limit>24.7</ci_upper_limit>
            <other_analysis_desc>Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lead-in Period</title>
          <description>Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2.</description>
        </group>
        <group group_id="E2">
          <title>Lead-in Failure Follow-up Period</title>
          <description>Following Lead in Period, participants who were responders at Week 6 or had normal-to-low vedolizumab clearance at Week 5 were not eligible for randomization and received vedolizumab 300 mg IV infusion at Week 6 plus 18 weeks follow-up.</description>
        </group>
        <group group_id="E3">
          <title>RTP: Standard Treatment Arm</title>
          <description>Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.</description>
        </group>
        <group group_id="E4">
          <title>RTP: VDZ Dose Optimization: Regimen A</title>
          <description>Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 and 300 mg IV infusion once every 4 weeks up to Week 26 in regimen A plus 18 weeks follow-up.</description>
        </group>
        <group group_id="E5">
          <title>RTP: VDZ Dose Optimization: Regimen B</title>
          <description>Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 followed by vedolizumab 600 mg once every 4 weeks up to Week 26 in regimen B plus 18 weeks follow-up.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Benign familial haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>TrialDisclosures@takeda.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03029143
org study id: Vedolizumab-4014
secondary id: U1111-1183-0451
nct id: NCT03029143
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to investigate the efficacy and safety of vedolizumab
      intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab
      IV dosing regimen over a 30 week treatment period in participants with moderately to severely
      active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined
      serum vedolizumab concentration threshold less than (<) 50 microgram per milliliter
      (microg/mL) and who are Week 6 non-responders based on partial Mayo score.
The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered
      as an IV infusion. It is being tested in this study with new doses. This study will
      investigate the efficacy and safety of dose optimization of vedolizumab IV, compared with
      standard dosing of vedolizumab IV, over a 30-week treatment period.

      The study will enroll approximately 250 moderately to severely active subjects with UC in
      order to randomize approximately 100 non-responder subjects with high vedolizumab drug
      clearance. Subjects will receive induction therapy of vedolizumab IV 300 mg on Day 1 and Week
      2 (Lead-in Period). At Week 5, serum vedolizumab concentration will be measured. At Week 6,
      subjects will be assessed for clinical response based on partial Mayo score.

      Results of both Week 5 vedolizumab concentration and Week 6 clinical response will determine
      the treatment pathway. Those who are non-responders based on partial Mayo score at Week 6 and
      who are assessed as having high vedolizumab clearance, based on a predefined Week 5 serum
      vedolizumab concentration threshold (<50 microg/mL) will be randomly assigned (by chance,
      like flipping a coin) to one of the two treatment groups:

        -  Vedolizumab IV Standard Treatment

        -  Vedolizumab IV Dose Optimized

      All randomized subjects will receive vedolizumab IV either 300 mg or 600 mg every 4 or 8
      weeks.

      This multi-center trial will be conducted in United States of America and Canada. The overall
      time to participate in this study is 56 weeks. Subjects will make multiple visits to the
      clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long
      term follow-up safety survey.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Achieving Mucosal Healing at Week 30
time frame: Week 30
description: Mucosal healing is defined as Mayo endoscopic subscore <=1 point. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
measure: Percentage of Participants Achieving Clinical Remission at Week 30
time frame: Week 30
description: Clinical remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
measure: Percentage of Participants Achieving Clinical Response at Week 30
time frame: Week 30
description: Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point, at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
measure: Percentage of Participants Achieving Clinical Response at Week 14
time frame: Week 14
description: Clinical response is defined as A reduction in partial Mayo score of ≥2 points and ≥25% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore.
measure: Percentage of Participants Achieving Corticosteroid-Free Remission
time frame: Week 30
description: Participants using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission. Mayo score was used in clinical trials to assess UC disease activity. Clinical Remission is defined as a complete Mayo score of <=2 points and no individual subscore >1 point at Week 30. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
measure: Percentage of Participants Achieving Durable Clinical Response
time frame: Weeks 14 and 30
description: A clinical response (based on partial Mayo score), which is defined as a reduction in partial Mayo score of ≥2 points and ≥25% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Weeks 14 and 30. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore. Percentage of participants with durable clinical response, clinical response achieved at both Weeks 14 and 30 are reported.
arm group label: Lead-in Period: Vedolizumab 300 mg
arm group type: Experimental
description: Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2. Participants who were non-responders based on partial Mayo score at Week 6 and who had high vedolizumab clearance (>0.14 L/day) at Week 5 were eligible for Randomized Treatment Period (RTP). Participants who were responders (Lead-In Failures) entered the 18-week follow-up period and discontinued the study.
arm group label: Randomized Treatment Period (RTP): Standard Treatment Arm
arm group type: Experimental
description: Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) at Weeks 6, 14 and 22 as standard treatment plus 18 weeks follow-up.
arm group label: RTP: Dose Optimized Arm
arm group type: Experimental
description: Following Lead-in Period, participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
intervention type: Drug
intervention name: Vedolizumab IV
description: Vedolizumab intravenous infusion.
arm group label: Lead-in Period: Vedolizumab 300 mg
arm group label: RTP: Dose Optimized Arm
arm group label: Randomized Treatment Period (RTP): Standard Treatment Arm
other name: Entyvio
other name: MLN0002
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
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country: Canada
country: United States
url: https://clinicaltrials.takeda.com/study-detail/5f6b60394db2bf003ab4a241?idFilter=%5B%22Vedolizumab-4014%22%5D
description: To obtain more information on the study, click 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/
provided document: 
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