<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/NCT03306446</url>
  </required_header>
  <id_info>
    <org_study_id>GETAID 2013-1</org_study_id>
    <nct_id>NCT03306446</nct_id>
  </id_info>
  <brief_title>Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab</brief_title>
  <acronym>CURE</acronym>
  <official_title>Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with&#xD;
      early CD. This study will not change the patient/physician relationship.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective will be to evaluate the sustained deep remission rate one year after&#xD;
      discontinuation of a 12 month course of adalimumab in adult patients with early CD who have&#xD;
      achieved deep remission at 12 months AND who were already in clinical remission (CDAI &lt; 150)&#xD;
      and biomarker remission (CRP &lt; 5 mg/L and fecal calprotectin &lt; 250) at 6 months. The study&#xD;
      will also address several questions:&#xD;
&#xD;
        -  What is the rate of deep remission after a 12-month course of adalimumab in early CD&#xD;
           patients?&#xD;
&#xD;
        -  What is the rate of deep remission 12 months after adalimumab discontinuation in&#xD;
           patients with deep remission after a 12-month course of adalimumab (thus defining&#xD;
           sustained deep remission) AND who were already in clinical remission (CDAI &lt; 150) and&#xD;
           biomarker remission (CRP &lt; 5 mg/L and fecal calprotectin &lt; 250) at 6 months?&#xD;
&#xD;
        -  What are the consequences of a treatment with adalimumab on the natural course of CD and&#xD;
           long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and&#xD;
           patient-reported outcomes)? Therefore the study will give information on the effect of a&#xD;
           12-month course of adalimumab in early CD patients, impact of &quot;drug holiday&quot; after deep&#xD;
           remission has been achieved, and long term effect of adalimumab on early CD course&#xD;
           (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported&#xD;
           outcomes). The study will also assess predictors of loss of deep remission at 2-year&#xD;
           evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of&#xD;
           adalimumab will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 17, 2015</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Actual">March 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained deep remission rate</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients with sustained deep remission at one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2-year deep remission rate</measure>
    <time_frame>2 years</time_frame>
    <description>Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Impact of an early treatment with adalimumab on long-term clinical outcomes</measure>
    <time_frame>5 years</time_frame>
    <description>Frequency and severity of adverse events in patients followed for 5 years</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>CD</condition>
  <arm_group>
    <arm_group_label>Adalimumab in monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Start adalimumab in monotherapy</intervention_name>
    <description>Discontinuation of Adalimumab in patients who achieved deep remission</description>
    <arm_group_label>Adalimumab in monotherapy</arm_group_label>
    <other_name>begin humira in monotherapie in Early crohn disease patient</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patient aged 18 years old to 75 years old 2. Patient with early luminal&#xD;
             Crohn's disease (less than 24 months since diagnosis), 3. Patient who is&#xD;
&#xD;
          -  intolerant to immunosuppressants or steroids, or&#xD;
&#xD;
          -  primarily not responders to immunosuppressants for at least 3 months [azathioprine: at&#xD;
             least 2.5 mg/kg/d; 6-mercaptopurine: at least 1.5 mg/kg/d; methotrexate: 25 mg/week&#xD;
             (subcutaneous or intramuscular route)], and/or&#xD;
&#xD;
          -  not responder to steroids [prednisolone equivalent at least 40 mg/d], and/or&#xD;
&#xD;
          -  steroid-dependent [unable to reduce corticosteroids below the equivalent of&#xD;
             prednisolone 10 mg/d or budesonide &lt; 6 mg/d within 3 months of starting&#xD;
             corticosteroids without recurrent active disease, or who have a relapse within 3&#xD;
             months of stopping corticosteroids], 4. Patient with CDAI &gt; 150, 5. Patient with at&#xD;
             least one ulcer in at least one affected segment (Magnetic Resonance Imaging (MRI) of&#xD;
             gastrointestinal tract or colonoscopy or by video capsule conducted after failure of&#xD;
             conventional therapy and within 12 weeks before inclusion in the study), 6. Patient&#xD;
             naïve for anti-TNF, 7. Patient whose physician decides to start adalimumab as&#xD;
             monotherapy independently from the study protocol, 8. Patient followed in a centre&#xD;
             belonging to the GETAID network. 9. Written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with active complex perianal fistula according to the definition of the&#xD;
             American Gastroenterological Association (AGA) [high anal fistula, abscess, proctitis,&#xD;
             multiple external openings],&#xD;
&#xD;
          -  Patient with stoma,&#xD;
&#xD;
          -  previous surgery in IBD&#xD;
&#xD;
          -  Pregnant or breastfeeding women, absence of contraception&#xD;
&#xD;
          -  Patient with any contra-indication to adalimumab.&#xD;
&#xD;
          -  Patient with any contra-indication to MRI&#xD;
&#xD;
          -  Minors and people unable to give their consent (because of their physical or mental&#xD;
             state).&#xD;
&#xD;
          -  Subject who has not given his/her consent to participate.&#xD;
&#xD;
          -  Subject participating in another study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoram Bouhnik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laurent Peyrin-Biroulet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Liege</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Amiens</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Besancon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen- Hopital de la Cote de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de CLERMONT FERRAND- Hopital Estain</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP- Hopital BEAUJON</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Colmar- Hopital Trousseau Medecine A</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier- Hopital saint Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU NANTES - Hôpital Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de NICE- Hopital Archet 2</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nimes- Hopital Carémeau</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP- Hopital COCHIN</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP- Hopital BICHAT</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMM</name>
      <address>
        <city>Paris</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux- Hopital Haut Levèque</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU LYON- Hopital Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU RENNES - Hopital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint Etienne- Hopital Nord</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de TOULOUSE</name>
      <address>
        <city>Toulouse</city>
        <zip>31403</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Tours - Hopital Trousseau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU NANCY - Hopital Brabois</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 21, 2015</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03306446
org study id: GETAID 2013-1
nct id: NCT03306446
lead sponsor: 
has dmc: No
This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with
      early CD. This study will not change the patient/physician relationship.
The main objective will be to evaluate the sustained deep remission rate one year after
      discontinuation of a 12 month course of adalimumab in adult patients with early CD who have
      achieved deep remission at 12 months AND who were already in clinical remission (CDAI < 150)
      and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months. The study
      will also address several questions:

        -  What is the rate of deep remission after a 12-month course of adalimumab in early CD
           patients?

        -  What is the rate of deep remission 12 months after adalimumab discontinuation in
           patients with deep remission after a 12-month course of adalimumab (thus defining
           sustained deep remission) AND who were already in clinical remission (CDAI < 150) and
           biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months?

        -  What are the consequences of a treatment with adalimumab on the natural course of CD and
           long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and
           patient-reported outcomes)? Therefore the study will give information on the effect of a
           12-month course of adalimumab in early CD patients, impact of "drug holiday" after deep
           remission has been achieved, and long term effect of adalimumab on early CD course
           (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported
           outcomes). The study will also assess predictors of loss of deep remission at 2-year
           evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of
           adalimumab will be assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained deep remission rate
time frame: 12 months
description: Number of patients with sustained deep remission at one year
measure: 2-year deep remission rate
time frame: 2 years
description: Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission
measure: Impact of an early treatment with adalimumab on long-term clinical outcomes
time frame: 5 years
description: Frequency and severity of adverse events in patients followed for 5 years
arm group label: Adalimumab in monotherapy
arm group type: Experimental
description: Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.
intervention type: Drug
intervention name: Start adalimumab in monotherapy
description: Discontinuation of Adalimumab in patients who achieved deep remission
arm group label: Adalimumab in monotherapy
other name: begin humira in monotherapie in Early crohn disease patient
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yoram Bouhnik, MD
role: Principal Investigator
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
last name: Laurent Peyrin-Biroulet, MD, PhD
role: Principal Investigator
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Adalimumab
sharing ipd: Undecided