<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/NCT03261206</url>
  </required_header>
  <id_info>
    <org_study_id>RP1610</org_study_id>
    <nct_id>NCT03261206</nct_id>
  </id_info>
  <brief_title>Stopping Aminosalicylate Therapy in Inactive Crohn's Disease</brief_title>
  <acronym>STATIC</acronym>
  <official_title>Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alimentiv Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academic Medical Organization of Southwestern Ontario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alimentiv Inc.</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>
      The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is&#xD;
      non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission&#xD;
      in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents&#xD;
      for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding&#xD;
      their effectiveness for CD.&#xD;
&#xD;
      In this open-label, randomized study, participants with CD in remission will be allocated to&#xD;
      either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if&#xD;
      withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in&#xD;
      maintaining CD remission over a 24 month period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD-related complications at 2 years</measure>
    <time_frame>24 months</time_frame>
    <description>CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CD-related complications at 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD-related or CD-treatment related surgeries at 1 year</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD-related or CD-treatment related surgeries at 2 years</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD-related or CD-treatment related hospitalizations at 1 year</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD-related or CD-treatment related hospitalizations at 2 years</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other CD-related or CD-treatment related complications at 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>Other complication excludes surgeries or hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other CD-related or CD-treatment related complications at 2 years</measure>
    <time_frame>24 months</time_frame>
    <description>Other complication excludes surgeries or hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first CD-related complication</measure>
    <time_frame>up to 24 months</time_frame>
    <description>CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease activity at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Disease activity assessed by HBI score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease activity at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Disease activity assessed by HBI score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease activity at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Disease activity assessed by HBI score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-assessed quality of life at 6 months</measure>
    <time_frame>Base line and 6 months</time_frame>
    <description>Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-assessed quality of life at 1 year</measure>
    <time_frame>Base line and 12 months</time_frame>
    <description>Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-assessed quality of life at 2 years</measure>
    <time_frame>Base line and 24 months</time_frame>
    <description>Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-reactive protein concentration at 6 months</measure>
    <time_frame>Base line and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-reactive protein concentration at 1 year</measure>
    <time_frame>Base line and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-reactive protein concentration at 2 years</measure>
    <time_frame>Base line and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fecal calprotectin concentration at 1 year</measure>
    <time_frame>Base line and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fecal calprotectin concentration at 2 years</measure>
    <time_frame>Base line and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CD-related drug treatment costs at 2 years</measure>
    <time_frame>12 months prior to enrollment and 24 months after enrollment</time_frame>
    <description>Estimated drug treatment costs before and after enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CD-related and total healthcare costs at 2 years</measure>
    <time_frame>12 months prior to enrollment and 24 months after enrollment</time_frame>
    <description>Estimated costs before and after enrollment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1580</enrollment>
  <condition>Crohn Disease</condition>
  <condition>Remission</condition>
  <arm_group>
    <arm_group_label>5-ASA Continuation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5-ASA Withdrawal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of the subjects will discontinue their aminosalicylate therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5-ASA Withdrawal</intervention_name>
    <description>Withdrawal of 5-ASA therapy</description>
    <arm_group_label>5-ASA Withdrawal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis of CD at least 3 months prior to enrollment&#xD;
&#xD;
          -  Taking any brand or dosage of an oral aminosalicylate for at least 6 months&#xD;
&#xD;
          -  Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75%&#xD;
             of prescribed doses)&#xD;
&#xD;
          -  CD currently in clinical remission&#xD;
&#xD;
          -  Able to participate fully in all aspects of the clinical trial&#xD;
&#xD;
          -  Written informed consent obtained and documented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular&#xD;
             disease-associated colitis&#xD;
&#xD;
          -  A diagnosis of short-bowel syndrome&#xD;
&#xD;
          -  Active perianal disease&#xD;
&#xD;
          -  Active fistulizing disease&#xD;
&#xD;
          -  A flare of CD within 3 months prior to enrollment requiring initiation/escalation of&#xD;
             medical therapy or surgery&#xD;
&#xD;
          -  Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Any major resective bowel surgery for CD (ileal resection, ileocecal resection,&#xD;
             proctocolectomy, colectomy, enterectomy, ostomy formation and repair,&#xD;
             anastomosis/reanastomosis) within 6 months prior to enrollment&#xD;
&#xD;
          -  Unwillingness to stop taking aminosalicylates for the duration of the trial&#xD;
&#xD;
          -  Untreated bile salt malabsorption that, in the opinion of the investigator, may&#xD;
             interfere with accurate study HBI assessment&#xD;
&#xD;
          -  Serious underlying disease other than CD that, in the opinion of the investigator, may&#xD;
             interfere with the subject's ability to participate fully in the study&#xD;
&#xD;
          -  History of active alcohol or drug abuse that, in the opinion of the investigator, may&#xD;
             interfere with the subject's ability to comply with the study procedures&#xD;
&#xD;
          -  Currently participating in another interventional trial, or previous participation&#xD;
             within the last 3 months&#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>Vipul Jairath, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University; London Health Sciences Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gordon Moran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heather MacAulay</last_name>
    <phone>226-270-7683</phone>
    <email>heather.macaulay@alimentiv.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vipul Jairath, MD</last_name>
    <phone>(226) 270-7683</phone>
    <phone_ext>1027</phone_ext>
    <email>vipul.jairath@robartsinc.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nima Hamidi</last_name>
      <email>nima.hamidi@ucalgary.ca</email>
    </contact>
    <contact_backup>
      <last_name>Heather Baylis</last_name>
      <email>hbaylis@ucalgary.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Remo Panaccione, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christopher Ma, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Miller</last_name>
      <phone>780-248-1035</phone>
      <email>rebecca.gildr@ualberta.ca</email>
    </contact>
    <investigator>
      <last_name>Brendan Philip Halloran, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dr. Jesse Siffledeen Professional Medical Corporation</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6L 6K3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christie Cor</last_name>
      <email>christie.cor@sedmgastro.ca</email>
    </contact>
    <investigator>
      <last_name>Jesse Sifledden, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>(G.I.R.I.) GI Research Institute</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Schmidt</last_name>
      <email>maria.a.schmit@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Gregory Rosenfeld, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Discovery Clinical Services Ltd.</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8T 5G4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>PerCuro Clinical Research Ltd.</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8V 3M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Manitoba - Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre - University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Prins</last_name>
      <phone>519-685-8500</phone>
      <phone_ext>33344</phone_ext>
      <email>heather.prins@lhsc.on.ca</email>
    </contact>
    <contact_backup>
      <last_name>Tricia Leavens</last_name>
      <phone>519-685-8500</phone>
      <phone_ext>35992</phone_ext>
      <email>tricia.leavens@lhsc.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Melanie Beaton, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Scott Shulman Medical Professional Corporation</name>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <zip>P1B2H3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Taunton Surgical Center</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1H 7K4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alana Carter</last_name>
      <email>alanacarter01@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Daniel M. Green</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3L9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dr. O. Tarabain Medicine Professional Corporation</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 1E6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle Marcon</last_name>
      <phone>519-915-4456</phone>
      <email>ml.marcon@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Osman Tarabain, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McGill University Healthcare</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>N6A 5B6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Laneuville</last_name>
      <email>jennifer.laneuville@muhc.mcgill.ca</email>
    </contact>
    <contact_backup>
      <last_name>Carolyne Lemieux</last_name>
      <email>carolune.lemieux@muhc.mcgill.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Talat Bessissow</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milan Italy</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Laura Annuziata, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali</name>
      <address>
        <city>Roma</city>
        <state>Rome</state>
        <zip>00135</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stafano Festa, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCA De Bellis</name>
      <address>
        <city>Castellana Grotte</city>
        <state>Via Turi</state>
        <zip>27-70013</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mauro Mastronardi, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Luigi Vanvitelli of Campania</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agnese Miranda, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Intituto Clinico Humanitas</name>
      <address>
        <city>Milano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvio Danese, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedale-Universita Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fabiana Zingone, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Campus Bio-Medico University of Rome</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paola Balestrieri, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>BYK - Kyiv</name>
      <address>
        <city>Kyiv</city>
        <zip>01030</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andriy E Dorofyeyev, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Danylo Halytsky Lviv National Medical University</name>
      <address>
        <city>Lviv</city>
        <zip>79059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Odesa Regional Clinical Hospital</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olena Levchenko, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ternopil University Hospital</name>
      <address>
        <city>Ternopil</city>
        <zip>46002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ihor Hospodarsky, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vinnytsia Nation Medical University N.I. Pirogov</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mykola Stanislavchuk, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Warrington and Halton Hospitals NHS Foundation Trust</name>
      <address>
        <city>Warrington</city>
        <state>Cheshire</state>
        <zip>WA5 1QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nemonie Marriott</last_name>
      <phone>1925 275513</phone>
      <email>Nemonie.marriott@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Subramaniam Ramakrishnan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Darlington Memorial Hospital</name>
      <address>
        <city>Darlington</city>
        <state>Durham</state>
        <zip>DL3 6HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ellen Brown</last_name>
      <phone>325743376</phone>
      <email>ellen.brown2@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Anjan Dhar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Basildon and Thurrock University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Basildon</city>
        <state>Essex</state>
        <zip>SS16 5NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Nicholson</last_name>
      <phone>1268524900</phone>
      <phone_ext>3599</phone_ext>
    </contact>
    <investigator>
      <last_name>Mark Jarvis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Blackburn Hospital</name>
      <address>
        <city>Blackburn</city>
        <state>Lancashire</state>
        <zip>BB2 3HH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St. Marks Hospital</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teena Varghese</last_name>
      <phone>44 20 8869 5804</phone>
    </contact>
    <contact_backup>
      <last_name>Sheena Quaid</last_name>
      <phone>44 20 8967 5000</phone>
      <phone_ext>3466</phone_ext>
    </contact_backup>
    <investigator>
      <last_name>Nalia Arebi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital</name>
      <address>
        <city>Sutton In Ashfield</city>
        <state>Nottinghamshire</state>
        <zip>NG17 4JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lynne Allsop</last_name>
      <phone>1623622515</phone>
      <phone_ext>3313</phone_ext>
      <email>lynne.allsop1@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Stephen Foley</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barnsley Hospital NHS Trust</name>
      <address>
        <city>Barnsley</city>
        <state>Yorkshire</state>
        <zip>S75 2EP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mishell Cunningham</last_name>
      <phone>004 41 22 643 2096</phone>
      <email>mishellcunningham@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Robert Atkinson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bedford Hospital NHS Trust</name>
      <address>
        <city>Bedford</city>
        <zip>MK42 9DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carina Gapin</last_name>
      <phone>44 123455122</phone>
      <phone_ext>5965</phone_ext>
      <email>carina.galpin@bedfordhospital.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Babur Javaid</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Suffolk Hospital</name>
      <address>
        <city>Bury St Edmunds</city>
        <zip>IP33 2QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Northern Care Alliance NHS Group - Fairfield General Hospital</name>
      <address>
        <city>Bury</city>
        <zip>BL9 7TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruth Craddock</last_name>
      <phone>0161 788 8720</phone>
      <email>ruth.craddock@pat.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Jimmy K Limdi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's NHS</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter NHS Foundation Trust</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suzie Marriott</last_name>
      <email>suzie.marriott@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Tariq Ahmad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>Nw3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Witele</last_name>
      <phone>0207 794 0500</phone>
      <email>eric.witele@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Charles Murray</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guy's and St. Thomas' Hospitals NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Namoi Hare</last_name>
      <phone>7918 338590</phone>
      <email>naomi.hare@gstt.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Peter Irving</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Luton and Dustable Hospital Foundation Trust</name>
      <address>
        <city>Luton</city>
        <zip>LU4 0DZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kabiru Kasamu</last_name>
      <email>Kasamu.Kabiru@ldh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Matthew Johnson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust and University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shellie Radford, RN</last_name>
      <phone>0115 9249924</phone>
      <phone_ext>60604</phone_ext>
      <email>Shellie.Radford@nuh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Gordon Moran, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <zip>RG1 5AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susanna Malkakorpi</last_name>
      <phone>118 322 6973</phone>
      <email>susanna.malkakorpi@royalberkshire.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Aminda De Silva, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Salford Ryal NHS Foundation Trust</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melanie Taylor</last_name>
      <phone>1612065116</phone>
      <email>melanie.taylor@srft.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Arash Assadsangabi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Airedale NHS Foundation Trust</name>
      <address>
        <city>Steeton</city>
        <zip>BD20 6TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emma Dooks</last_name>
      <phone>01535 292279</phone>
      <email>Emma.Dooks@anhst.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Richard Shenderey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Hampshire County Hospital</name>
      <address>
        <city>Winchester</city>
        <zip>SO22 5DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Italy</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT03261206
org study id: RP1610
nct id: NCT03261206
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is
      non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.
Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission
      in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents
      for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding
      their effectiveness for CD.

      In this open-label, randomized study, participants with CD in remission will be allocated to
      either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if
      withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in
      maintaining CD remission over a 24 month period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: CD-related complications at 2 years
time frame: 24 months
description: CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
measure: CD-related complications at 1 year
time frame: 12 months
description: CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
measure: CD-related or CD-treatment related surgeries at 1 year
time frame: 12 months
measure: CD-related or CD-treatment related surgeries at 2 years
time frame: 24 months
measure: CD-related or CD-treatment related hospitalizations at 1 year
time frame: 12 months
measure: CD-related or CD-treatment related hospitalizations at 2 years
time frame: 24 months
measure: Other CD-related or CD-treatment related complications at 1 year
time frame: 12 months
description: Other complication excludes surgeries or hospitalizations
measure: Other CD-related or CD-treatment related complications at 2 years
time frame: 24 months
description: Other complication excludes surgeries or hospitalizations
measure: Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year
time frame: 12 months
measure: Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years
time frame: 24 months
measure: Time to first CD-related complication
time frame: up to 24 months
description: CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
measure: Change in disease activity at 6 months
time frame: 6 months
description: Disease activity assessed by HBI score
measure: Change in disease activity at 12 months
time frame: 12 months
description: Disease activity assessed by HBI score
measure: Change in disease activity at 24 months
time frame: 24 months
description: Disease activity assessed by HBI score
measure: Change in self-assessed quality of life at 6 months
time frame: Base line and 6 months
description: Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
measure: Change in self-assessed quality of life at 1 year
time frame: Base line and 12 months
description: Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
measure: Change in self-assessed quality of life at 2 years
time frame: Base line and 24 months
description: Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
measure: Change in C-reactive protein concentration at 6 months
time frame: Base line and 6 months
measure: Change in C-reactive protein concentration at 1 year
time frame: Base line and 12 months
measure: Change in C-reactive protein concentration at 2 years
time frame: Base line and 24 months
measure: Change in fecal calprotectin concentration at 1 year
time frame: Base line and 12 months
measure: Change in fecal calprotectin concentration at 2 years
time frame: Base line and 24 months
measure: Change in CD-related drug treatment costs at 2 years
time frame: 12 months prior to enrollment and 24 months after enrollment
description: Estimated drug treatment costs before and after enrollment
measure: Change in CD-related and total healthcare costs at 2 years
time frame: 12 months prior to enrollment and 24 months after enrollment
description: Estimated costs before and after enrollment
arm group label: 5-ASA Continuation
arm group type: No Intervention
description: Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
arm group label: 5-ASA Withdrawal
arm group type: Experimental
description: Half of the subjects will discontinue their aminosalicylate therapy
intervention type: Other
intervention name: 5-ASA Withdrawal
description: Withdrawal of 5-ASA therapy
arm group label: 5-ASA Withdrawal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vipul Jairath, MD
role: Principal Investigator
affiliation: Western University; London Health Sciences Centre
last name: Gordon Moran, MD
role: Principal Investigator
affiliation: University of Nottingham
last name: Heather MacAulay
phone: 226-270-7683
email: heather.macaulay@alimentiv.com
last name: Vipul Jairath, MD
phone: (226) 270-7683
phone ext: 1027
email: vipul.jairath@robartsinc.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
country: Canada
country: Italy
country: Ukraine
country: United Kingdom
responsible party type: Sponsor
mesh term: Crohn Disease
sharing ipd: No