<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/NCT03257345</url>
  </required_header>
  <id_info>
    <org_study_id>RHM MED1307</org_study_id>
    <nct_id>NCT03257345</nct_id>
  </id_info>
  <brief_title>VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease</brief_title>
  <acronym>VEST</acronym>
  <official_title>VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liverpool University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's&#xD;
      disease. The aim of this study is to capture the early real life UK experience of vedolizumab&#xD;
      including the outcomes of treatment, describing the patient population treated, drug&#xD;
      persistence, IBD control PROM, durable remission, tolerance and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Steroid-free remission</measure>
    <time_frame>Week 56</time_frame>
    <description>Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remission and response</measure>
    <time_frame>Multiple</time_frame>
    <description>Remission and response rates at week 6, 14, 30 and 54</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durable remission</measure>
    <time_frame>Multiple</time_frame>
    <description>Durable remission / response i.e. at week 14, 30 and 54</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of vedolizumab</measure>
    <time_frame>TBC</time_frame>
    <description>Effect of vedolizumab on disease activity as measured by the PRO2, IBD Control PROM, Physician's Global Assessment and biomarkers of disease activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HES data</measure>
    <time_frame>1 year</time_frame>
    <description>Healthcare usage at 1 year using HES data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance and safety</measure>
    <time_frame>1 year</time_frame>
    <description>Tolerance and safety of vedolizumab at 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of disease</measure>
    <time_frame>TBC</time_frame>
    <description>Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab</description>
  </secondary_outcome>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Ulcerative Colitis</condition>
  <condition>Crohn's Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with inflammatory bowel disease due to start vedolizumab for the first time as&#xD;
        part of routine therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants being given vedolizumab as part of routine care, and vedo naïve prior to&#xD;
             study&#xD;
&#xD;
          -  Age 18 or over&#xD;
&#xD;
          -  Written informed consent obtained from patient for participation in the UK IBD&#xD;
             Registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unwilling to take part in the UK IBD Registry&#xD;
&#xD;
          -  Unable to obtain written informed consent&#xD;
&#xD;
          -  Patient is, in the opinion of the investigator, not suitable to participate in the&#xD;
             study&#xD;
&#xD;
          -  Patients with contraindications to the use of vedolizumab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fraser Cummings, MBChB</last_name>
    <phone>023 8120 8462</phone>
    <email>fraser.cummings@uhs.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cheryl S Booker, BA</last_name>
    <phone>023 8120 3713</phone>
    <email>cheryl.booker@uhs.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Cornwall Hospitals NHS Trust</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Old, BSc</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter NHS Foundation Trust</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tariq Ahmad, MBChB</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brighton and Sussex University Hospitals NHS Trust</name>
      <address>
        <city>Brighton</city>
        <state>East Sussex</state>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Smith, MbChB</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kingston Hospital NHS Foundation Trust</name>
      <address>
        <city>Kingston</city>
        <state>Greater London</state>
        <zip>KT2 7QB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fiona Donovan, MSc</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Klaartje Kok, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>London North West Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ailsa Hart, BMBCh</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stuart Bloom, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Irving, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Kent, MBChB</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheryl S Booker, BA</last_name>
      <phone>023 8120 3713</phone>
      <email>cheryl.booker@uhs.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Fraser Cummings, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Hertfordshire Hospitals NHS Trust</name>
      <address>
        <city>Watford</city>
        <state>Hertfordshire</state>
        <zip>WD18 0HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Landy, MBChB</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maidstone and Tunbridge Wells NHS Foundation Trust</name>
      <address>
        <city>Maidstone</city>
        <state>Kent</state>
        <zip>ME16 9QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bijay Baburajan, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>United Lincolnshire Hospitals NHS Trust</name>
      <address>
        <city>Grantham</city>
        <state>Lincolnshire</state>
        <zip>NG31 8DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tariq Mahmood, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keith Bodger, MBChB</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>York Teaching Hospital NHS Foundation Trust</name>
      <address>
        <city>York</city>
        <state>North Yorkshire</state>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Veysey, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shrewsbury and Telford Hospital NHS Trust</name>
      <address>
        <city>Shrewsbury</city>
        <state>Shropshire</state>
        <zip>SY3 8XQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeffrey Butterworth, MBChB</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barnsley Hospital NHS Foundation Trust</name>
      <address>
        <city>Barnsley</city>
        <state>South Yorkshire</state>
        <zip>S75 2EP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kapil Kapur, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alan Lobo, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West Suffolk NHS Foundation Trust</name>
      <address>
        <city>Bury Saint Edmunds</city>
        <state>Suffolk</state>
        <zip>IP33 2QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Sharpstone, MB BS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Newcastle upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>Tyne And Wear</state>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John C Mansfield, MBBS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Royal Wolverhampton NHS Trust</name>
      <address>
        <city>Wolverhampton</city>
        <state>West Midlands</state>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Brookes, MBChB</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Calderdale and Huddersfield NHS Foundation Trust</name>
      <address>
        <city>Huddersfield</city>
        <state>West Yorkshire</state>
        <zip>HD3 3EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sunil Sonwalkar, MBBS</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>September 20, 2018</last_update_submitted>
  <last_update_submitted_qc>September 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Southampton NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Fraser Cummings</investigator_full_name>
    <investigator_title>Consultant Gastroenterologist</investigator_title>
  </responsible_party>
  <keyword>Real world outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257345
org study id: RHM MED1307
nct id: NCT03257345
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated device: No
Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's
      disease. The aim of this study is to capture the early real life UK experience of vedolizumab
      including the outcomes of treatment, describing the patient population treated, drug
      persistence, IBD control PROM, durable remission, tolerance and safety.
observational model: Case-Only
time perspective: Prospective
measure: Steroid-free remission
time frame: Week 56
description: Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2
measure: Remission and response
time frame: Multiple
description: Remission and response rates at week 6, 14, 30 and 54
measure: Durable remission
time frame: Multiple
description: Durable remission / response i.e. at week 14, 30 and 54
measure: Effect of vedolizumab
time frame: TBC
description: Effect of vedolizumab on disease activity as measured by the PRO2, IBD Control PROM, Physician's Global Assessment and biomarkers of disease activity
measure: HES data
time frame: 1 year
description: Healthcare usage at 1 year using HES data
measure: Tolerance and safety
time frame: 1 year
description: Tolerance and safety of vedolizumab at 1 year
measure: Description of disease
time frame: TBC
description: Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fraser Cummings, MBChB
phone: 023 8120 8462
email: fraser.cummings@uhs.nhs.uk
last name: Cheryl S Booker, BA
phone: 023 8120 3713
email: cheryl.booker@uhs.nhs.uk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University Hospital Southampton NHS Foundation Trust
investigator full name: Fraser Cummings
investigator title: Consultant Gastroenterologist
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases