xml: <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/NCT05992142</url>
    </required_header>
    <id_info>
      <org_study_id>BIRD2022001</org_study_id>
      <secondary_id>2022-001683-10</secondary_id>
      <nct_id>NCT05992142</nct_id>
    </id_info>
    <brief_title>ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA</brief_title>
    <acronym>CARUC-ASA</acronym>
    <official_title>ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ferring Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW</source>
    <oversight_info>
      <has_dmc>Yes</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>
        For the last years the aim of the management of ulcerative colitis (UC) has become more&#xD;
        ambitious including not only clinical remission but also the achievement of biological&#xD;
        remission, endoscopic and histological healing, which are associated with less flares,&#xD;
        hospitalizations and surgeries. About 50% of the patients with UC followed in routine are&#xD;
        treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to&#xD;
        describe the different levels of remission (clinical, endoscopic, histological) in UC&#xD;
        patients treated only by 5-ASA, that report to be in clinical remission during a routine&#xD;
        follow-up visit. The factors associated with different levels of remission (demographic,&#xD;
        5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of&#xD;
        life will be examined through patient questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The management of inflammatory bowel diseases aims to induce not only a clinical&#xD;
        corticosteroid-free remission but also a deep remission defined by the achievement of mucosal&#xD;
        healing. In ulcerative colitis (UC), mucosal healing has been nicely correlated with a better&#xD;
        outcome of the disease. A lack of mucosal healing after a first steroid course is associated&#xD;
        with a bad outcome including higher hospitalizations and more clinical relapses after 1 year.&#xD;
        The absence of mucosal healing has also been correlated with higher rates of colectomy.&#xD;
        Mucosal healing is defined by the absence of ulcers and includes patients with an endoscopic&#xD;
        Mayo subscore of zero and one. Recently, a significantly better outcome has been demonstrated&#xD;
        in patients having an endoscopic Mayo subscore of zero instead of one as well as a&#xD;
        histological healing on the biopsies. The fecal biomarkers, especially the fecal&#xD;
        calprotectin, have a high accuracy for the prediction of ongoing endoscopic and histologic&#xD;
        inflammation in patients in clinical remission. Fecal calprotectin is well correlated with&#xD;
        the Mayo endoscopic subscore and can discriminate patients with an endoscopic Mayo subscore&#xD;
        of zero versus one or more by using a cut-off of 150 microgram/gram. A residual histologic&#xD;
        inflammation is associated with a fecal calprotectin of 155 microgram/gram or more.&#xD;
        Subsequently the management of UC has evolved and aims to induce a tighter control of the&#xD;
        disease including a complete endoscopic response and a histological healing. It is currently&#xD;
        not known how well these patients who report being in clinical remission are actually in&#xD;
        objectively defined remission. As a deep remission is so important for the future evaluation&#xD;
        of the disease, it is important to understand the factors linked to the absence of such&#xD;
        remission.&#xD;
  &#xD;
        The primary objective of this study is to describe the percentage of the different levels of&#xD;
        remission (clinical, endoscopic, histological), in UC patients, treated by 5-ASA for at least&#xD;
        6 months, free of concomitant UC medications for at least 3 months and presenting for a&#xD;
        routine follow-up visit.&#xD;
  &#xD;
        The secondary objectives of this study are:&#xD;
  &#xD;
          -  to identify the factors associated to the absence of deep remission (demographic, UC&#xD;
             history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence)&#xD;
  &#xD;
          -  to describe the adherence of the patients to the 5-ASA medications and its impact on the&#xD;
             remission status.&#xD;
  &#xD;
          -  to describe the regimen of 5-ASA prescription (dosage, oral/local form) and its impact&#xD;
             on the remission status.&#xD;
  &#xD;
          -  to describe the quality of life of the patients with UC on 5-ASA and its correlation&#xD;
             with the level of remission.&#xD;
  &#xD;
          -  to understand the implication of patient's perspective and physician's perspective in&#xD;
             patient lacking deep remission.&#xD;
  &#xD;
          -  to analyze the reasons of non-deep remission&#xD;
  &#xD;
        This study is a national, multicenter, transversal, interventional study conducted in Belgium&#xD;
        (16 centers will participate). The trial design is as follows:&#xD;
  &#xD;
          -  All subjects will undergo screening procedures. The screening visit of eligible patients&#xD;
             will include the review of inclusion and exclusion criteria, and the informed consent&#xD;
             form procedure. After screening, if the patient fulfils all inclusion and none of the&#xD;
             exclusion criteria, and is willing to participate, the inclusion visit will be performed&#xD;
             at the same time. The gastroenterologist will record the characteristics of patients and&#xD;
             of the disease, medical history, current and past UC treatments in the last year before&#xD;
             inclusion, and the PRO-2 score and bowel urgency in the last 3 days before the visit.&#xD;
  &#xD;
          -  A sigmoidoscopy with 2 biopsies (taken in the most inflamed area) as well as a fecal&#xD;
             calprotectin measurement will be performed during the inclusion visit. The sigmoidoscopy&#xD;
             procedure will be scored locally by the gastroenterologist with the endoscopic Mayo&#xD;
             score and the UCEIS score. The Geboes score will be calculated centrally.&#xD;
  &#xD;
          -  The patient will complete the Short Health Scale and the Medication Adherence Report&#xD;
             Scale.&#xD;
  &#xD;
          -  Biochemistry (including hematocrit, hemoglobin, platelets count, leucocytes, CRP, urea&#xD;
             and serum creatinine) is not obligatory, but if it is planned in the routine management&#xD;
             of the patient, these data will be recorded for study purposes.&#xD;
  &#xD;
          -  In patients not achieving complete endoscopic remission (Endoscopic Mayo subscore &gt;0),&#xD;
             an exploratory questionnaire will be answered by the physician about &quot;physician&#xD;
             perspective&quot; regarding the treatment strategy to explore the supposed reasons of the&#xD;
             absence of UC remission. Depending on the answer, an exploratory questionnaire can be&#xD;
             directed towards the patient exploring the reason for possible low adherence or&#xD;
             deliberately refusing other medications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 25, 2022</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>transversal study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Complete clinical remission</measure>
      <time_frame>week 0</time_frame>
      <description>Complete clinical remission is defined by a PRO-2 = 0 and no bowel urgency</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Endoscopic remission</measure>
      <time_frame>week 0</time_frame>
      <description>Endoscopic remission is defined by an endoscopic MAYO subscore of 0 or 1 and/or by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 0 or 1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Histological remission</measure>
      <time_frame>week 0</time_frame>
      <description>Histological remission will be defined by the absence of any acute inflammatory activity on the biopsies according to the Geboes score, including Geboes 0-1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Deep remission will be defined by the combination of complete clinical, complete endoscopic and histological remission</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Demographic factors associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Demographic factors questionnaire: year of birth, sex (male/female), ethnic origin (Caucasian/Black/Hispanic/Asian/Other) and smoking status (Smoker with &gt; 1 cigarette/day, Non-smoker or Former smoker)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease characteristics associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Disease characteristics questionnaire: diagnosis date ('DD-MMMM-YYYY') and UC Montreal classification [E1 (Ulcerative proctitis), E2 (left-sided UC), E3 (Extensive) or Pancolitis]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical history associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Medical history questionnaire with a list of current and past concomitant medical conditions including extra-intestinal manifestations (yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication history associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>A questionnaire (yes/no) about UC medication history prescribed the year before inclusion and current medication use including corticosteroids including local forms, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs): brand name, date of start and stop, frequency, route of administration and dosage. Details on past and current 5-ASA use will be recorded: brand name, date of start and stop, formulation (oral, rectal, enema), dosage, frequency.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease activity based on PRO-2 score associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Disease activity measurement based on Two component Patient Reported Outcome (PRO-2) score (stool frequency and rectal bleeding; average score of the last 3 days before the visit), using a grading scale from 0 (normal) to 3 (for rectal bleeding: blood alone passed and for stool frequency: &gt;= 5 stools more than normal)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease activity based on bowel urgency associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Disease activity measurement based on bowel urgency for the past 24 hours using a VAS scale from 0 (no urgency) to 10 (worst possible urgency)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease activity based on endoscopic score associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Disease activity measurement based on Mayo and UCEIS endoscopic score, using a grading scale from 0 (normal/inactive) to 3 (active)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease activity based on histological Geboes score associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Disease activity measurements based on histological Geboes score, with grade 0-1=inactive/absent, grade 2= chronic inflammation and grade 3-5 = acute inflammation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease activity based on objective markers associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Disease activity measurement based on the objective markers fecal calprotectine value (microg/g) and C-reactive protein (CRP) value (mg/L) if available</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence associated to the absence of deep remission</measure>
      <time_frame>week 0</time_frame>
      <description>Adherence based on Medication Adherence Report Scale (MARS-5)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of adherent patients on 5-ASA medications</measure>
      <time_frame>week 0</time_frame>
      <description>The percentage of adherent patients on 5-ASA medications, and an adherent patient is defined by a total Medication Adherence Report Scale (MARS-5) score of 21 or by a MARS-5 score of 4 for each individual question.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The impact of adherence on the remission status</measure>
      <time_frame>week 0</time_frame>
      <description>The percentage of adherent patients on 5-ASA medications will be compared between the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of prescription of the different 5-ASA regimens</measure>
      <time_frame>week 0</time_frame>
      <description>The percentage of prescription of the different 5-ASA regimens, and the prescription rate of the different 5-ASA regimens depends on the dosage (grams), oral and/or topical form.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The impact of the prescription rate of the different 5-ASA regimens on the remission status</measure>
      <time_frame>week 0</time_frame>
      <description>The prescription rate of the different 5-ASA regimens will be compared between the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of the quality of life of the patients with UC on 5-ASA</measure>
      <time_frame>week 0</time_frame>
      <description>Quality of life based on validated Short Health Scale (a four-part visual analogue scale questionnaire using open-ended questions that are designed to assess the impact of IBD on a health related quality of life, with score between 0 and 40; lower score, better quality of life)).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation of the quality of life scores with the level of remission</measure>
      <time_frame>week 0</time_frame>
      <description>Quality of life scores will be correlated with the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The factors associated with non-deep remission coming from either physician management or patient perception</measure>
      <time_frame>week 0</time_frame>
      <description>In patients not achieving complete endoscopic remission (Endoscopic Mayo subscore &gt;0), an exploratory questionnaire will be answered by the physician about &quot;physician perspective&quot; regarding the treatment strategy to explore the supposed reasons of the absence of UC remission. Depending on the answer, an exploratory questionnaire can be directed towards the patient exploring the reason for possible low adherence or deliberately refusing other medications.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>UC patients</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>5-ASA</intervention_name>
      <description>Assessment of the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, who report to be in clinical remission during a routine follow-up visit</description>
      <arm_group_label>UC patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female ≥ 18 years&#xD;
  &#xD;
            2. Confirmed diagnosis of UC&#xD;
  &#xD;
            3. Patients with PRO-2 ≤ 1, with ≤ 1 for stool frequency and 0 for rectal bleeding in the&#xD;
               last 3 days before the visit.&#xD;
  &#xD;
            4. Recruitment during a routine follow-up visit.&#xD;
  &#xD;
            5. Subjects to whom 5-ASA treatment has been prescribed for at least 6 months (any type&#xD;
               of oral and/or rectal 5 ASA, any dosage) and with the dose of 5-ASA stable for at&#xD;
               least 2 weeks (including suppositories) prior to inclusion.&#xD;
  &#xD;
            6. Prescription of 5-ASA is within the locally approved Summary of Product&#xD;
               Characteristics (SmPCs)&#xD;
  &#xD;
            7. Subjects free of concomitant UC medication (corticosteroids, immunomodulators,&#xD;
               biologics, JAK inhibitors, S1PR modulator or investigational drugs) for at least 3&#xD;
               months&#xD;
  &#xD;
            8. Subject or the subject's legally acceptable representative have the capacity to&#xD;
               understand and (voluntary) sign an informed consent form&#xD;
  &#xD;
            9. Be able to adhere to the study visit schedule and other protocol requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Any subject who meets one of the following criteria will not qualify for entry in the&#xD;
          study:&#xD;
  &#xD;
            1. Subjects currently treated by immunomodulators, biologics, JAK inhibitors, S1PR&#xD;
               modulator and investigational drugs and within the last three months. A history of&#xD;
               immunomodulator or biologic or JAK inhibitor or S1PR modulator and investigational&#xD;
               drugs use in the past is not an exclusion criteria.&#xD;
  &#xD;
            2. Subjects recruited during hospitalization, or via the urgency department for active&#xD;
               UC, or during an unscheduled visit for emergency reasons.&#xD;
  &#xD;
            3. UC patients with a total colectomy, with or without IPAA&#xD;
  &#xD;
            4. Patients with indetermined colitis (IBDU)&#xD;
  &#xD;
            5. Women that are pregnant&#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>Catherine Reenaers, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Study Principal Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ingrid Arijs, PhD</last_name>
      <phone>+32499317005</phone>
      <email>ingrid.arijs@birdgroup.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laura Vansteenkiste</last_name>
      <phone>+32470851337</phone>
      <email>laura.vansteenkiste@birdgroup.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Imelda Ziekenhuis</name>
        <address>
          <city>Bonheiden</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lieven Pouillon</last_name>
        <email>lieven.pouillon@imelda.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Erasme</name>
        <address>
          <city>Bruxelles</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anneline Cremer</last_name>
        <email>Anneline.Cremer@erasme.ulb.ac.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitair Ziekenhuis Antwerpen</name>
        <address>
          <city>Edegem</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michaël Somers</last_name>
        <email>Michael.Somers@uza.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ziekenhuis Oost-Limburg</name>
        <address>
          <city>Genk</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Evelien Humblet</last_name>
        <email>Evelien.Humblet@zol.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AZ Sint-Lucas Gent</name>
        <address>
          <city>Gent</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Beatrijs Strubbe</last_name>
        <email>Beatrijs.Strubbe@AZSTLUCAS.BE</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitair Ziekenhuis Gent</name>
        <address>
          <city>Gent</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jeroen Geldof</last_name>
        <email>Jeroen.Geldof@uzgent.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AZ Groeninge</name>
        <address>
          <city>Kortrijk</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas Billiet</last_name>
        <email>THOMAS.BILLIET@azgroeninge.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Liège - Site Sart Tilman</name>
        <address>
          <city>Liège</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Catherine Reenaers</last_name>
        <email>catherine.reenaers@chuliege.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Groupe santé CHC Clinique du MontLégia</name>
        <address>
          <city>Liège</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Arnaud Colard</last_name>
        <email>arnaud.colard@chc.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AZ Voorkempen Malle</name>
        <address>
          <city>Malle</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Annelies Verreth</last_name>
        <email>Annelies.Verreth@Emmaus.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AZ Damiaan</name>
        <address>
          <city>Oostende</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guy Lambrecht</last_name>
        <email>glambrecht@azdamiaan.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AZ Delta</name>
        <address>
          <city>Roeselare</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Filip Baert</last_name>
        <email>filip.baert@azdelta.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sint-Andries ziekenhuis Tielt</name>
        <address>
          <city>Tielt</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Astrid De Zutter</last_name>
        <email>astrid.de.zutter@sintandriestielt.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AZ Vesalius</name>
        <address>
          <city>Tongeren</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Annelies Posen</last_name>
        <email>Annelies.Posen@azvesalius.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AZ Turnhout</name>
        <address>
          <city>Turnhout</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christophe Claessens</last_name>
        <email>Christophe.Claessens@azturnhout.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU UCL Namur -Site Mont Godinne</name>
        <address>
          <city>Yvoir</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jean-Francois Rahier</last_name>
        <email>jfrahier@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <link>
      <url>https://www.birdgroup.be/en</url>
      <description>BIRD website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>December 13, 2022</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>remission</keyword>
    <keyword>5-aminosalicylate acid (5-ASA)</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>
  
  
text: 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/NCT05992142
  org study id: BIRD2022001
  secondary id: 2022-001683-10
  nct id: NCT05992142
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  For the last years the aim of the management of ulcerative colitis (UC) has become more
        ambitious including not only clinical remission but also the achievement of biological
        remission, endoscopic and histological healing, which are associated with less flares,
        hospitalizations and surgeries. About 50% of the patients with UC followed in routine are
        treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to
        describe the different levels of remission (clinical, endoscopic, histological) in UC
        patients treated only by 5-ASA, that report to be in clinical remission during a routine
        follow-up visit. The factors associated with different levels of remission (demographic,
        5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of
        life will be examined through patient questionnaires.
  The management of inflammatory bowel diseases aims to induce not only a clinical
        corticosteroid-free remission but also a deep remission defined by the achievement of mucosal
        healing. In ulcerative colitis (UC), mucosal healing has been nicely correlated with a better
        outcome of the disease. A lack of mucosal healing after a first steroid course is associated
        with a bad outcome including higher hospitalizations and more clinical relapses after 1 year.
        The absence of mucosal healing has also been correlated with higher rates of colectomy.
        Mucosal healing is defined by the absence of ulcers and includes patients with an endoscopic
        Mayo subscore of zero and one. Recently, a significantly better outcome has been demonstrated
        in patients having an endoscopic Mayo subscore of zero instead of one as well as a
        histological healing on the biopsies. The fecal biomarkers, especially the fecal
        calprotectin, have a high accuracy for the prediction of ongoing endoscopic and histologic
        inflammation in patients in clinical remission. Fecal calprotectin is well correlated with
        the Mayo endoscopic subscore and can discriminate patients with an endoscopic Mayo subscore
        of zero versus one or more by using a cut-off of 150 microgram/gram. A residual histologic
        inflammation is associated with a fecal calprotectin of 155 microgram/gram or more.
        Subsequently the management of UC has evolved and aims to induce a tighter control of the
        disease including a complete endoscopic response and a histological healing. It is currently
        not known how well these patients who report being in clinical remission are actually in
        objectively defined remission. As a deep remission is so important for the future evaluation
        of the disease, it is important to understand the factors linked to the absence of such
        remission.
  
        The primary objective of this study is to describe the percentage of the different levels of
        remission (clinical, endoscopic, histological), in UC patients, treated by 5-ASA for at least
        6 months, free of concomitant UC medications for at least 3 months and presenting for a
        routine follow-up visit.
  
        The secondary objectives of this study are:
  
          -  to identify the factors associated to the absence of deep remission (demographic, UC
             history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence)
  
          -  to describe the adherence of the patients to the 5-ASA medications and its impact on the
             remission status.
  
          -  to describe the regimen of 5-ASA prescription (dosage, oral/local form) and its impact
             on the remission status.
  
          -  to describe the quality of life of the patients with UC on 5-ASA and its correlation
             with the level of remission.
  
          -  to understand the implication of patient's perspective and physician's perspective in
             patient lacking deep remission.
  
          -  to analyze the reasons of non-deep remission
  
        This study is a national, multicenter, transversal, interventional study conducted in Belgium
        (16 centers will participate). The trial design is as follows:
  
          -  All subjects will undergo screening procedures. The screening visit of eligible patients
             will include the review of inclusion and exclusion criteria, and the informed consent
             form procedure. After screening, if the patient fulfils all inclusion and none of the
             exclusion criteria, and is willing to participate, the inclusion visit will be performed
             at the same time. The gastroenterologist will record the characteristics of patients and
             of the disease, medical history, current and past UC treatments in the last year before
             inclusion, and the PRO-2 score and bowel urgency in the last 3 days before the visit.
  
          -  A sigmoidoscopy with 2 biopsies (taken in the most inflamed area) as well as a fecal
             calprotectin measurement will be performed during the inclusion visit. The sigmoidoscopy
             procedure will be scored locally by the gastroenterologist with the endoscopic Mayo
             score and the UCEIS score. The Geboes score will be calculated centrally.
  
          -  The patient will complete the Short Health Scale and the Medication Adherence Report
             Scale.
  
          -  Biochemistry (including hematocrit, hemoglobin, platelets count, leucocytes, CRP, urea
             and serum creatinine) is not obligatory, but if it is planned in the routine management
             of the patient, these data will be recorded for study purposes.
  
          -  In patients not achieving complete endoscopic remission (Endoscopic Mayo subscore >0),
             an exploratory questionnaire will be answered by the physician about "physician
             perspective" regarding the treatment strategy to explore the supposed reasons of the
             absence of UC remission. Depending on the answer, an exploratory questionnaire can be
             directed towards the patient exploring the reason for possible low adherence or
             deliberately refusing other medications.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: transversal study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete clinical remission
  time frame: week 0
  description: Complete clinical remission is defined by a PRO-2 = 0 and no bowel urgency
  measure: Endoscopic remission
  time frame: week 0
  description: Endoscopic remission is defined by an endoscopic MAYO subscore of 0 or 1 and/or by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 0 or 1
  measure: Histological remission
  time frame: week 0
  description: Histological remission will be defined by the absence of any acute inflammatory activity on the biopsies according to the Geboes score, including Geboes 0-1
  measure: Deep remission
  time frame: week 0
  description: Deep remission will be defined by the combination of complete clinical, complete endoscopic and histological remission
  measure: Demographic factors associated to the absence of deep remission
  time frame: week 0
  description: Demographic factors questionnaire: year of birth, sex (male/female), ethnic origin (Caucasian/Black/Hispanic/Asian/Other) and smoking status (Smoker with > 1 cigarette/day, Non-smoker or Former smoker)
  measure: Disease characteristics associated to the absence of deep remission
  time frame: week 0
  description: Disease characteristics questionnaire: diagnosis date ('DD-MMMM-YYYY') and UC Montreal classification [E1 (Ulcerative proctitis), E2 (left-sided UC), E3 (Extensive) or Pancolitis]
  measure: Medical history associated to the absence of deep remission
  time frame: week 0
  description: Medical history questionnaire with a list of current and past concomitant medical conditions including extra-intestinal manifestations (yes/no)
  measure: Medication history associated to the absence of deep remission
  time frame: week 0
  description: A questionnaire (yes/no) about UC medication history prescribed the year before inclusion and current medication use including corticosteroids including local forms, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs): brand name, date of start and stop, frequency, route of administration and dosage. Details on past and current 5-ASA use will be recorded: brand name, date of start and stop, formulation (oral, rectal, enema), dosage, frequency.
  measure: Disease activity based on PRO-2 score associated to the absence of deep remission
  time frame: week 0
  description: Disease activity measurement based on Two component Patient Reported Outcome (PRO-2) score (stool frequency and rectal bleeding; average score of the last 3 days before the visit), using a grading scale from 0 (normal) to 3 (for rectal bleeding: blood alone passed and for stool frequency: >= 5 stools more than normal)
  measure: Disease activity based on bowel urgency associated to the absence of deep remission
  time frame: week 0
  description: Disease activity measurement based on bowel urgency for the past 24 hours using a VAS scale from 0 (no urgency) to 10 (worst possible urgency)
  measure: Disease activity based on endoscopic score associated to the absence of deep remission
  time frame: week 0
  description: Disease activity measurement based on Mayo and UCEIS endoscopic score, using a grading scale from 0 (normal/inactive) to 3 (active)
  measure: Disease activity based on histological Geboes score associated to the absence of deep remission
  time frame: week 0
  description: Disease activity measurements based on histological Geboes score, with grade 0-1=inactive/absent, grade 2= chronic inflammation and grade 3-5 = acute inflammation
  measure: Disease activity based on objective markers associated to the absence of deep remission
  time frame: week 0
  description: Disease activity measurement based on the objective markers fecal calprotectine value (microg/g) and C-reactive protein (CRP) value (mg/L) if available
  measure: Adherence associated to the absence of deep remission
  time frame: week 0
  description: Adherence based on Medication Adherence Report Scale (MARS-5)
  measure: The percentage of adherent patients on 5-ASA medications
  time frame: week 0
  description: The percentage of adherent patients on 5-ASA medications, and an adherent patient is defined by a total Medication Adherence Report Scale (MARS-5) score of 21 or by a MARS-5 score of 4 for each individual question.
  measure: The impact of adherence on the remission status
  time frame: week 0
  description: The percentage of adherent patients on 5-ASA medications will be compared between the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission)
  measure: The percentage of prescription of the different 5-ASA regimens
  time frame: week 0
  description: The percentage of prescription of the different 5-ASA regimens, and the prescription rate of the different 5-ASA regimens depends on the dosage (grams), oral and/or topical form.
  measure: The impact of the prescription rate of the different 5-ASA regimens on the remission status
  time frame: week 0
  description: The prescription rate of the different 5-ASA regimens will be compared between the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission)
  measure: Quantification of the quality of life of the patients with UC on 5-ASA
  time frame: week 0
  description: Quality of life based on validated Short Health Scale (a four-part visual analogue scale questionnaire using open-ended questions that are designed to assess the impact of IBD on a health related quality of life, with score between 0 and 40; lower score, better quality of life)).
  measure: Correlation of the quality of life scores with the level of remission
  time frame: week 0
  description: Quality of life scores will be correlated with the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission)
  measure: The factors associated with non-deep remission coming from either physician management or patient perception
  time frame: week 0
  description: In patients not achieving complete endoscopic remission (Endoscopic Mayo subscore >0), an exploratory questionnaire will be answered by the physician about "physician perspective" regarding the treatment strategy to explore the supposed reasons of the absence of UC remission. Depending on the answer, an exploratory questionnaire can be directed towards the patient exploring the reason for possible low adherence or deliberately refusing other medications.
  arm group label: UC patients
  arm group type: Other
  description: UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit
  intervention type: Drug
  intervention name: 5-ASA
  description: Assessment of the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, who report to be in clinical remission during a routine follow-up visit
  arm group label: UC patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Catherine Reenaers, MD, PhD
  role: Principal Investigator
  affiliation: Study Principal Investigator
  last name: Ingrid Arijs, PhD
  phone: +32499317005
  email: ingrid.arijs@birdgroup.be
  last name: Laura Vansteenkiste
  phone: +32470851337
  email: laura.vansteenkiste@birdgroup.be
  facility: 
  status: Recruiting
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  country: Belgium
  url: https://www.birdgroup.be/en
  description: BIRD website
  responsible party type: Sponsor
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Ulcer
  sharing ipd: No