<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/NCT01698307</url>
  </required_header>
  <id_info>
    <org_study_id>RP1202</org_study_id>
    <nct_id>NCT01698307</nct_id>
  </id_info>
  <brief_title>Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy</brief_title>
  <acronym>REACT2</acronym>
  <official_title>A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alimentiv Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alimentiv Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess if the implementation of an enhanced treatment algorithm will improve the management&#xD;
      Crohn's Disease compared to a conventional Step-care approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During&#xD;
      disease exacerbations, pharmacological or surgical intervention is usually needed to&#xD;
      re-establish remission. Ideally, strategies should be employed to maintain patients in&#xD;
      long-term remission while minimizing exposure to corticosteroids and reduce therapy-related&#xD;
      toxicity.&#xD;
&#xD;
      Nevertheless, in reality many patients with CD do not receive effective therapy and their&#xD;
      disease often remains active, leading to uncontrolled inflammation and complications from&#xD;
      either the underlying disease or corticosteroids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2014</start_date>
  <completion_date type="Actual">April 16, 2020</completion_date>
  <primary_completion_date type="Actual">April 16, 2020</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>
    <intervention_model_description>algorithm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of Crohn's Disease-related complications at two years</measure>
    <time_frame>2 years</time_frame>
    <description>Crohn''s Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.</measure>
    <time_frame>six months, 12 months</time_frame>
    <description>Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first Crohn's Disease-related complication, first Crohn's Disease-related hospitalizations, and first all cause hospitalizations at 6 months and 12 months.</measure>
    <time_frame>six months, 12 months</time_frame>
    <description>Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of patients at one year and two years who are in Deep Remission without disease progression</measure>
    <time_frame>1 year, 2 years</time_frame>
    <description>Disease progression is defined as the de novo development of strictures or fistula, the occurrence of an intra-abdominal abscess, or surgery for Crohn's Disease (resection, bypass, stricturoplasty).</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients at one year and two years who are in Deep Remission</measure>
    <time_frame>1 year, 2 years</time_frame>
    <description>Deep remission defined as a Harvey-Bradshaw Index (HBI) less than or equal to 4, no steriods for the treatment of Crohn's Disease, and normal C-reactive protein</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients at one year and 2 years who are in Clinical Remission</measure>
    <time_frame>1 year, 2 years</time_frame>
    <description>Clinical remission defined as an Harvey-Bradshaw Index (HBI) of equal to or less than 4.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in C-reactive protein</measure>
    <time_frame>6 months, 1 year, 2 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in health related QoL, patient and physician global rating</measure>
    <time_frame>6 months, 1 year, 2 years</time_frame>
    <description>The EuroQoL instrument [EQ-5D] will be used to measure quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient and physician satisfaction</measure>
    <time_frame>2 years</time_frame>
    <description>At the completion of study participation, subjects and physicians in both treatment groups will be asked to complete a satisfaction questionnaire regarding the information provided and their overall satisfaction with the approach to the management of CD. The physicians will also be asked if they would recommend the CD treatment algorithm to their colleagues, and if they think it would be feasible to sustain this algorithm within their practice setting.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1095</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Enhanced Treatment Algorithm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Step-care Algorithm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Treatment Algorithm</intervention_name>
    <description>The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.</description>
    <arm_group_label>Enhanced Treatment Algorithm</arm_group_label>
    <other_name>Adalimumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Step-care Algorithm</intervention_name>
    <description>Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.</description>
    <arm_group_label>Conventional Step-care Algorithm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis of CD&#xD;
&#xD;
          -  Written informed consent must be obtained and documented.&#xD;
&#xD;
          -  Willing to utilize study supply of adalimumab provided in syringe format, if indicated&#xD;
             according to treatment algorithm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of&#xD;
             the investigator, may interfere with the patient's ability to comply with study&#xD;
             procedures.&#xD;
&#xD;
          -  Latex allergy or other conditions in which adalimumab syringes are contraindicated&#xD;
&#xD;
          -  Currently participating, or planning to participate in a study involving&#xD;
             investigational product within 24 months that may interfere with the patient's ability&#xD;
             to comply with study procedures.&#xD;
&#xD;
          -  Previously failed all classes of tumor necrosis factor (TNF) antagonists for the&#xD;
             treatment of CD.&#xD;
&#xD;
          -  Diagnosis of short bowel syndrome&#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>Brian G Feagan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Robarts Clinical Trials - Western University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Research Center, LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheville Gastroenterology Associates, PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott and White Memorial Hospital</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duane Sheppard, GI Inc.</name>
      <address>
        <city>Dartmouth</city>
        <state>Nova Scotia</state>
        <zip>B2Y 4G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Office of Dr. Bruce Musgrave</name>
      <address>
        <city>Kentville</city>
        <state>Nova Scotia</state>
        <zip>B4N 0A3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Fashir Medical Inc.</name>
      <address>
        <city>Sydney</city>
        <state>Nova Scotia</state>
        <zip>B1P 1P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S. and T. Shulman Medicine Professional Corporation</name>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <zip>P1B 2H3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oravec Medicine Professional Corporation</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1J 2J9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sudbury Endoscopy Center</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3C 5K6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Office of Dr. Pierre Laflamme</name>
      <address>
        <city>Saint-Charles-Borromée</city>
        <state>Quebec</state>
        <zip>J6E 2C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verein fur Wissenschaft und Fortbildung</name>
      <address>
        <city>Oldenburg</city>
        <state>Lower Saxony</state>
        <zip>26123</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fur Gastroenterologie am Bayerischen Platz</name>
      <address>
        <city>Berlin</city>
        <zip>10825</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologie Eppendorfer Baum</name>
      <address>
        <city>Hamburg</city>
        <zip>20249</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG1 5AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <state>Dorset</state>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Hampshire County Hospital</name>
      <address>
        <city>Winchester</city>
        <state>Hampshire</state>
        <zip>SO2 5DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation - John Radcliffe Hospital</name>
      <address>
        <city>Headington</city>
        <state>Oxford</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Coventry</name>
      <address>
        <city>Coventry</city>
        <state>West Midlands</state>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital - Royal Wolverhampton NHS Trust</name>
      <address>
        <city>Wolverhampton</city>
        <state>West Midlands</state>
        <zip>WV1 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>D1406</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.</citation>
    <PMID>23856361</PMID>
  </reference>
  <reference>
    <citation>Feagan BG, Panaccione R, Sandborn WJ, D'Haens GR, Schreiber S, Rutgeerts PJ, Loftus EV Jr, Lomax KG, Yu AP, Wu EQ, Chao J, Mulani P. Effects of adalimumab therapy on incidence of hospitalization and surgery in Crohn's disease: results from the CHARM study. Gastroenterology. 2008 Nov;135(5):1493-9. doi: 10.1053/j.gastro.2008.07.069. Epub 2008 Aug 3.</citation>
    <PMID>18848553</PMID>
  </reference>
  <reference>
    <citation>Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.</citation>
    <PMID>20393175</PMID>
  </reference>
  <reference>
    <citation>D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkuhn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.</citation>
    <PMID>18295023</PMID>
  </reference>
  <reference>
    <citation>Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, Diamond RH, Chen DM, Pritchard ML, Sandborn WJ. Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastroenterol Hepatol. 2006 May;4(5):621-30. doi: 10.1016/j.cgh.2006.03.002. Erratum In: Clin Gastroenterol Hepatol. 2006 Jul;4(7):931.</citation>
    <PMID>16678077</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <keyword>Deep Remission</keyword>
  <keyword>Complications</keyword>
  <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>No</sharing_ipd>
    <ipd_description>The study is site randomization not subject.</ipd_description>
  </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/NCT01698307
org study id: RP1202
nct id: NCT01698307
lead sponsor: 
has dmc: No
is fda regulated device: No
Assess if the implementation of an enhanced treatment algorithm will improve the management
      Crohn's Disease compared to a conventional Step-care approach.
Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During
      disease exacerbations, pharmacological or surgical intervention is usually needed to
      re-establish remission. Ideally, strategies should be employed to maintain patients in
      long-term remission while minimizing exposure to corticosteroids and reduce therapy-related
      toxicity.

      Nevertheless, in reality many patients with CD do not receive effective therapy and their
      disease often remains active, leading to uncontrolled inflammation and complications from
      either the underlying disease or corticosteroids.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: algorithm
primary purpose: Treatment
masking: None (Open Label)
measure: Risk of Crohn's Disease-related complications at two years
time frame: 2 years
description: Crohn''s Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.
measure: Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.
time frame: six months, 12 months
description: Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.
measure: Time to first Crohn's Disease-related complication, first Crohn's Disease-related hospitalizations, and first all cause hospitalizations at 6 months and 12 months.
time frame: six months, 12 months
description: Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.
measure: Proportion of patients at one year and two years who are in Deep Remission without disease progression
time frame: 1 year, 2 years
description: Disease progression is defined as the de novo development of strictures or fistula, the occurrence of an intra-abdominal abscess, or surgery for Crohn's Disease (resection, bypass, stricturoplasty).
measure: Proportion of patients at one year and two years who are in Deep Remission
time frame: 1 year, 2 years
description: Deep remission defined as a Harvey-Bradshaw Index (HBI) less than or equal to 4, no steriods for the treatment of Crohn's Disease, and normal C-reactive protein
measure: Proportion of patients at one year and 2 years who are in Clinical Remission
time frame: 1 year, 2 years
description: Clinical remission defined as an Harvey-Bradshaw Index (HBI) of equal to or less than 4.
measure: Change in C-reactive protein
time frame: 6 months, 1 year, 2 years
measure: Change in health related QoL, patient and physician global rating
time frame: 6 months, 1 year, 2 years
description: The EuroQoL instrument [EQ-5D] will be used to measure quality of life.
measure: Patient and physician satisfaction
time frame: 2 years
description: At the completion of study participation, subjects and physicians in both treatment groups will be asked to complete a satisfaction questionnaire regarding the information provided and their overall satisfaction with the approach to the management of CD. The physicians will also be asked if they would recommend the CD treatment algorithm to their colleagues, and if they think it would be feasible to sustain this algorithm within their practice setting.
arm group label: Enhanced Treatment Algorithm
arm group type: Active Comparator
description: The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
arm group label: Conventional Step-care Algorithm
arm group type: Other
description: Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).
intervention type: Other
intervention name: Enhanced Treatment Algorithm
description: The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
arm group label: Enhanced Treatment Algorithm
other name: Adalimumab
intervention type: Other
intervention name: Conventional Step-care Algorithm
description: Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
arm group label: Conventional Step-care Algorithm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian G Feagan, MD
role: Principal Investigator
affiliation: Robarts Clinical Trials - Western University
facility: 
facility: 
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facility: 
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country: Canada
country: Germany
country: United Kingdom
country: United States
citation: Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.
PMID: 23856361
citation: Feagan BG, Panaccione R, Sandborn WJ, D'Haens GR, Schreiber S, Rutgeerts PJ, Loftus EV Jr, Lomax KG, Yu AP, Wu EQ, Chao J, Mulani P. Effects of adalimumab therapy on incidence of hospitalization and surgery in Crohn's disease: results from the CHARM study. Gastroenterology. 2008 Nov;135(5):1493-9. doi: 10.1053/j.gastro.2008.07.069. Epub 2008 Aug 3.
PMID: 18848553
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PMID: 20393175
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PMID: 18295023
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PMID: 16678077
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Adalimumab
sharing ipd: No
ipd description: The study is site randomization not subject.