<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/NCT01670240</url>
  </required_header>
  <id_info>
    <org_study_id>2011-004268-31</org_study_id>
    <nct_id>NCT01670240</nct_id>
  </id_info>
  <brief_title>Adalimumab in the Treatment of Chronic Pouchitis</brief_title>
  <acronym>ADAP</acronym>
  <official_title>Adalimumab (Humira) in the Treatment of Chronic Pouchitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study wants to investigate the efficiency of biological treatment for chronic pouchitis.&#xD;
      Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It&#xD;
      is examined in patients with ulcerative colitis.&#xD;
&#xD;
      The primary objective evaluation is to evaluate the clinically effect of biological therapy&#xD;
      (adalimumab) in patients with chronic pouchitis.&#xD;
&#xD;
      Secondary objective is to evaluate the effect of biological therapy on the endoscopical and&#xD;
      histological inflammatory activity.&#xD;
&#xD;
      It is a double-blinded randomized placebo controlled study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical response on treatment with Adalimumab</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira).&#xD;
Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement after 12 weeks of treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of patients with a clinical improvement (PDAI reduction ≥ 2)at week 12 See the description of clinical improvement and PDAI under primary endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical remission after 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic and histologic response after treatment with Adalimumab</measure>
    <time_frame>12 weeks</time_frame>
    <description>Effect (reduction in PDAI)of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis Endoscopical and histological activity is defined from PDAI (pouchitis disease activity index). Endoscopically the presence of Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates or Ulceration, gives 1 point each (max 6 points). Histological the presence of polymorphic nuclear leukocyte infiltration and ulceration each gives 1-3 points regarding severity (max 6 points)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Ulcerative Colitis</condition>
  <condition>Pouchitis</condition>
  <arm_group>
    <arm_group_label>Adalimumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Every second week, mg: 160-80-40-40-40-40 12 weeks in all</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Given as the active comparator, every second week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <arm_group_label>Adalimumab</arm_group_label>
    <other_name>Humira</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Operated with proctocolectomy and construction of an IPAA&#xD;
&#xD;
          -  Prior to surgery diagnosed with ulcerative colitis according to established&#xD;
             clinically, radiologic, endoscopic and histological criteria.&#xD;
&#xD;
          -  Diagnosed with chronic pouchitis as defined above&#xD;
&#xD;
          -  PDAI ≥ 7, with the clinically part of PDAI &gt;2 and the endoscopic part of PDAI &gt;3&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Negative stool cultures for bacterial bowel pathogens and negative stool microscopy&#xD;
             for parasites&#xD;
&#xD;
          -  Serology negative for chronic hepatitis B&#xD;
&#xD;
          -  Negative examination for tuberculosis (including x-ray of thorax and a interferon&#xD;
             gamma test)&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with glucocorticoids within the last 4 weeks&#xD;
&#xD;
          -  Diagnosed with Crohn's disease&#xD;
&#xD;
          -  Need of an interpreter or if patients do not understand oral or written information.&#xD;
&#xD;
          -  Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising&#xD;
             from the pouch&#xD;
&#xD;
          -  Abuse of medicine, alcohol or drugs&#xD;
&#xD;
          -  Ongoing treatment with NSAID (non steroid anti inflammatory drug)&#xD;
&#xD;
          -  Pregnancy or nursing&#xD;
&#xD;
          -  A diverting stoma&#xD;
&#xD;
          -  Malignancy or other severe chronic disease or expected longevity less than one year&#xD;
&#xD;
          -  Patients diagnosed with immune deficiency&#xD;
&#xD;
          -  Ongoing infectious disease&#xD;
&#xD;
          -  Contraindications against treatment with tumor necrosis factor-alpha antibody, such as&#xD;
             heart disease, former cancer disease, in vivo vaccination within the last 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Kjeldsen, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>January 27, 2016</last_update_submitted>
  <last_update_submitted_qc>January 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Mie Dilling Kjaer</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>IPAA</keyword>
  <keyword>Pouchitis</keyword>
  <keyword>Ulcerative colitis</keyword>
  <keyword>Pouch</keyword>
  <keyword>Adalimumab</keyword>
  <keyword>Humira</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>Pouchitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
  </intervention_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/NCT01670240
org study id: 2011-004268-31
nct id: NCT01670240
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study wants to investigate the efficiency of biological treatment for chronic pouchitis.
      Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It
      is examined in patients with ulcerative colitis.

      The primary objective evaluation is to evaluate the clinically effect of biological therapy
      (adalimumab) in patients with chronic pouchitis.

      Secondary objective is to evaluate the effect of biological therapy on the endoscopical and
      histological inflammatory activity.

      It is a double-blinded randomized placebo controlled study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical response on treatment with Adalimumab
time frame: 12 weeks
description: The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira).
Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points).
measure: Clinical improvement after 12 weeks of treatment
time frame: 12 weeks
description: The number of patients with a clinical improvement (PDAI reduction ≥ 2)at week 12 See the description of clinical improvement and PDAI under primary endpoint
measure: Clinical remission after 12 weeks
time frame: 12 weeks
description: The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)
measure: Endoscopic and histologic response after treatment with Adalimumab
time frame: 12 weeks
description: Effect (reduction in PDAI)of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis Endoscopical and histological activity is defined from PDAI (pouchitis disease activity index). Endoscopically the presence of Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates or Ulceration, gives 1 point each (max 6 points). Histological the presence of polymorphic nuclear leukocyte infiltration and ulceration each gives 1-3 points regarding severity (max 6 points)
arm group label: Adalimumab
arm group type: Active Comparator
description: Every second week, mg: 160-80-40-40-40-40 12 weeks in all
arm group label: Placebo
arm group type: Placebo Comparator
description: Given as the active comparator, every second week
intervention type: Drug
intervention name: Adalimumab
arm group label: Adalimumab
other name: Humira
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Kjeldsen, Phd
role: Principal Investigator
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Mie Dilling Kjaer
investigator title: Principal investigator
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Pouchitis
mesh term: Adalimumab