<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/NCT03839680</url>
  </required_header>
  <id_info>
    <org_study_id>P/2019/412</org_study_id>
    <nct_id>NCT03839680</nct_id>
  </id_info>
  <brief_title>Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis</brief_title>
  <acronym>ACTIVEDO</acronym>
  <official_title>Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab&#xD;
      (VDZ) who achieve mucosal healing at week 54 of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">April 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1</measure>
    <time_frame>54 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0</measure>
    <time_frame>14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0</measure>
    <time_frame>30 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0</measure>
    <time_frame>54 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic pattern of mucosal healing</measure>
    <time_frame>54 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Risk factors of mucosal healing</measure>
    <time_frame>14 weeks</time_frame>
    <description>Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:&#xD;
Demographic data: age, gender, smoking habit&#xD;
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)&#xD;
Treatments:&#xD;
Previous therapy used including number of TNF ɑ antagonist and reason for failure&#xD;
Concomitant drugs: corticosteroids, immunosuppressors&#xD;
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk factors of mucosal healing</measure>
    <time_frame>30 weeks</time_frame>
    <description>Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:&#xD;
Demographic data: age, gender, smoking habit&#xD;
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)&#xD;
Treatments:&#xD;
Previous therapy used including number of TNF ɑ antagonist and reason for failure&#xD;
Concomitant drugs: corticosteroids, immunosuppressors&#xD;
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk factors of mucosal healing</measure>
    <time_frame>54 weeks</time_frame>
    <description>Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:&#xD;
Demographic data: age, gender, smoking habit&#xD;
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)&#xD;
Treatments:&#xD;
Previous therapy used including number of TNF ɑ antagonist and reason for failure&#xD;
Concomitant drugs: corticosteroids, immunosuppressors&#xD;
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points</measure>
    <time_frame>14 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points</measure>
    <time_frame>30 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points</measure>
    <time_frame>54 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1</measure>
    <time_frame>14 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1</measure>
    <time_frame>30 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1</measure>
    <time_frame>54 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical remission defined by a total Mayo score ≤ 2 with no sub-score &gt; 1</measure>
    <time_frame>14 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical remission defined by a total Mayo score ≤ 2 with no sub-score &gt; 1</measure>
    <time_frame>30 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical remission defined by a total Mayo score ≤ 2 with no sub-score &gt; 1</measure>
    <time_frame>54 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Histologic remission defined by a Nancy index score at 0 or 1</measure>
    <time_frame>14 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Histologic remission defined by a Nancy index score at 0 or 1</measure>
    <time_frame>30 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Histologic remission defined by a Nancy index score at 0 or 1</measure>
    <time_frame>54 weeks</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ulcerative Colitis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopy</intervention_name>
    <description>The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from ulcerative colitis for who an endoscopic examen is performed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years,&#xD;
&#xD;
          -  established diagnosis of ulcerative colitis for at least 3 months&#xD;
&#xD;
          -  moderate to severe active ulcerative colitis with a Mayo endoscopic sub-score ≥ 1&#xD;
             before vedolizumab introduction&#xD;
&#xD;
          -  patients receiving vedolizumab according to French drug labelling (previous exposure&#xD;
             to anti-TNF, contraindicated or intolerant to anti-TNF),&#xD;
&#xD;
          -  possibility of concomitant therapy including corticosteroids and immunosuppressors,&#xD;
&#xD;
          -  patients naive to anti-integrin,&#xD;
&#xD;
          -  no contraindication to proctosigmoidoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years&#xD;
&#xD;
          -  ulcerative colitis not proven, Crohn's disease, or inderterminate colitis&#xD;
&#xD;
          -  personal history of high-grade dysplasia or colorectal cancer&#xD;
&#xD;
          -  surgery with ileo-anal anastomosis&#xD;
&#xD;
          -  patients' refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucine Vuitton, MD</last_name>
      <phone>0381667322</phone>
      <email>vuitton@chu-besancon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucine Vuitton</last_name>
      <phone>0381667322</phone>
      <email>lvuitton@chu-besancon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucine Vuitton</last_name>
      <phone>0381667322</phone>
      <email>lvuitton@chu-besancon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHI de Haute-Saône</name>
      <address>
        <city>Vesoul</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucine Vuitton</last_name>
      <phone>0381667322</phone>
      <email>lvuitton@chu-besancon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ulcerative colitis, endoscopic activity, mucosal healing, vedolizumab</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839680
org study id: P/2019/412
nct id: NCT03839680
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab
      (VDZ) who achieve mucosal healing at week 54 of treatment.
observational model: Cohort
time perspective: Prospective
measure: Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1
time frame: 54 weeks
measure: Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
time frame: 14 weeks
measure: Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
time frame: 30 weeks
measure: Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
time frame: 54 weeks
measure: Endoscopic pattern of mucosal healing
time frame: 54 weeks
measure: Risk factors of mucosal healing
time frame: 14 weeks
description: Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
Demographic data: age, gender, smoking habit
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)
Treatments:
Previous therapy used including number of TNF ɑ antagonist and reason for failure
Concomitant drugs: corticosteroids, immunosuppressors
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.
measure: Risk factors of mucosal healing
time frame: 30 weeks
description: Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
Demographic data: age, gender, smoking habit
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)
Treatments:
Previous therapy used including number of TNF ɑ antagonist and reason for failure
Concomitant drugs: corticosteroids, immunosuppressors
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.
measure: Risk factors of mucosal healing
time frame: 54 weeks
description: Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
Demographic data: age, gender, smoking habit
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)
Treatments:
Previous therapy used including number of TNF ɑ antagonist and reason for failure
Concomitant drugs: corticosteroids, immunosuppressors
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.
measure: Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points
time frame: 14 weeks
measure: Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points
time frame: 30 weeks
measure: Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points
time frame: 54 weeks
measure: Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1
time frame: 14 weeks
measure: Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1
time frame: 30 weeks
measure: Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1
time frame: 54 weeks
measure: Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1
time frame: 14 weeks
measure: Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1
time frame: 30 weeks
measure: Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1
time frame: 54 weeks
measure: Histologic remission defined by a Nancy index score at 0 or 1
time frame: 14 weeks
measure: Histologic remission defined by a Nancy index score at 0 or 1
time frame: 30 weeks
measure: Histologic remission defined by a Nancy index score at 0 or 1
time frame: 54 weeks
intervention type: Procedure
intervention name: Endoscopy
description: The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No