<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/NCT01696942</url>
  </required_header>
  <id_info>
    <org_study_id>36497</org_study_id>
    <nct_id>NCT01696942</nct_id>
  </id_info>
  <brief_title>Cimzia Versus Mesalamine for Crohn's Recurrence</brief_title>
  <official_title>Use of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to Mesalamine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UCB Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates&#xD;
      compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy&#xD;
      for Crohn's disease.&#xD;
&#xD;
        1. To evaluate the difference in clinical recurrence rates between certolizumab and&#xD;
           mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following&#xD;
           ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI).&#xD;
&#xD;
        2. To compare the endoscopic recurrence rates at one year following surgery between&#xD;
           patients treated with certolizumab and mesalamine.&#xD;
&#xD;
        3. To compare medication side-effects and tolerance of therapy, including the need to&#xD;
           interrupt therapy due to side-effects, the incidence of opportunistic infections, and a&#xD;
           general assessment of each patient's health and well-being using the short-form 36&#xD;
           (SF-36).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crohn's disease is an autoimmune, pan-intestinal disease which can affect any portion of the&#xD;
      alimentary tract, but which has a preference for the small intestine, the colon, and the&#xD;
      anus. It is now well established that Crohn's disease most commonly presents with an&#xD;
      ileocolic distribution, followed by involvement of the small intestine, the colon, and the&#xD;
      anus. Treatment for Crohn's disease is principally medical, reserving surgery to address&#xD;
      complications from the disease which cannot be adequately resolved with medication alone. The&#xD;
      single greatest challenge in treating this incurable disease is dealing with its recurrence&#xD;
      rate. The cumulative probability of disease recurrence is quite high, with 75% of Crohn's&#xD;
      patients requiring abdominal surgery at some point during their life.&#xD;
&#xD;
      Following surgery, recurrence rates are significant, varying depending on the manner in which&#xD;
      recurrence is defined. With regard to clinical recurrences, where the recrudescence of the&#xD;
      disease is associated with symptoms caused by new intestinal lesions, the recurrence rate is&#xD;
      10-20% per year.In some instances, clinical recurrences can appear within 3 months of&#xD;
      surgery. Taking into account the need for additional surgery as defining a &quot;surgical&#xD;
      recurrence&quot;, reoperation rates for Crohn's disease range from 16% to 65% 10 years after a&#xD;
      previous surgery. When recurrence is viewed from the vantage point of evidence of new Crohn's&#xD;
      disease activity based on radiographic studies, radiographic recurrences range from 41-60%&#xD;
      over the first 10 years following surgery. One of the most common measures of recurrence has&#xD;
      become demonstrating evidence of new Crohn's disease activity based on colonoscopy. This&#xD;
      endoscopic recurrence has consistently been shown to be as high as 50-75% at 3 months after&#xD;
      surgery, and 50-90% at 12 months. It is widely accepted by physicians treating Crohn's&#xD;
      patients that the appearance of endoscopic lesions has prognostic significance, as endoscopic&#xD;
      evidence of Crohn's disease temporally precedes radiographic, clinical and surgical&#xD;
      recurrences.&#xD;
&#xD;
      The role that Cimzia should play in preventing recurrence of Crohn's disease following&#xD;
      ileocolectomy for Crohn's disease remains to be determined, as does its relative advantages&#xD;
      and disadvantages compared to the use of mesalamine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of accrual&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Recurrence Rates of Crohn's Disease</measure>
    <time_frame>4 weeks, 3 months, 6 months, 9 months, and 12 months</time_frame>
    <description>To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Endoscopic Recurrence of Crohn's Disease</measure>
    <time_frame>One year following enrollment</time_frame>
    <description>To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Cimzia treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mesalamine treatment arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cimzia</intervention_name>
    <description>400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks</description>
    <arm_group_label>Cimzia treatment arm</arm_group_label>
    <other_name>Certolizumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesalamine</intervention_name>
    <description>mesalamine 800 mg orally three times daily</description>
    <arm_group_label>Mesalamine treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥18 years of age or older with Crohn's disease of any phenotype (luminal&#xD;
             disease, perforating disease, stricturing disease) with an ileocolic distribution.&#xD;
&#xD;
          -  Ileocolic Crohn's disease severe enough to require ileocolectomy (either open or&#xD;
             laparoscopic).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years of age, as there is little data on pediatric patients&#xD;
             and since the Colorectal Surgery service only treats patients 18 years of age or&#xD;
             older.&#xD;
&#xD;
          -  Patients undergoing an ileocolectomy for any reason besides Crohn's disease.&#xD;
&#xD;
          -  Patients requiring a stoma.&#xD;
&#xD;
          -  Patients with short-bowel syndrome.&#xD;
&#xD;
          -  Patients who are incarcerated, due to difficulties with frequent clinic visits given&#xD;
             their incarceration and transportation issues.&#xD;
&#xD;
          -  Patients who received previous anti-TNF therapy from infliximab or adalimumab within&#xD;
             three months of surgery, or patients who have a history of a severe hypersensitivity&#xD;
             reaction to infliximab or adalimumab&#xD;
&#xD;
          -  Patients with a positive PPD and a suspicious finding on a chest x-ray suggestive of&#xD;
             tuberculosis, or any patient with a history of tuberculosis.&#xD;
&#xD;
          -  Patients who require postoperative therapy besides either mesalamine or certolizumab&#xD;
             (steroids, antibiotics, and immunomodulator therapy would not be permitted starting at&#xD;
             4 weeks after ileocolectomy).&#xD;
&#xD;
          -  Patients with significant psychiatric disorders (i.e. schizophrenia) and those with&#xD;
             significant cognitive disorders, due to the difficulties with this patient group&#xD;
             remaining compliant with frequent clinic visits, and due to the difficulty evaluating&#xD;
             quality of life measures in these patients.&#xD;
&#xD;
          -  Patients with a history of malignancy.&#xD;
&#xD;
          -  Patients with a history of any demyelinating neurologic disease or a history of&#xD;
             seizures.&#xD;
&#xD;
          -  Patients with a history of severe congestive heart failure.&#xD;
&#xD;
          -  Patients with a history of hepatitis B or C virus.&#xD;
&#xD;
          -  Patients who are pregnant or who become pregnant.&#xD;
&#xD;
          -  Involvement in any other clinical studies which use study medications.&#xD;
&#xD;
          -  The subject has a condition, which, in the opinion of the investigator, would&#xD;
             compromise the study or well-being of the subject or prevent the subject from meeting&#xD;
             or performing the study requirements.&#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>David B Stewart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Whelan G, Farmer RG, Fazio VW, Goormastic M. Recurrence after surgery in Crohn's disease. Relationship to location of disease (clinical pattern) and surgical indication. Gastroenterology. 1985 Jun;88(6):1826-33. doi: 10.1016/0016-5085(85)90007-1.</citation>
    <PMID>3996839</PMID>
  </reference>
  <reference>
    <citation>Mekhjian HS, Switz DM, Watts HD, Deren JJ, Katon RM, Beman FM. National Cooperative Crohn's Disease Study: factors determining recurrence of Crohn's disease after surgery. Gastroenterology. 1979 Oct;77(4 Pt 2):907-13. No abstract available.</citation>
    <PMID>467942</PMID>
  </reference>
  <reference>
    <citation>Kyle J. Prognosis after ileal resection for Crohn's disease. Br J Surg. 1971 Oct;58(10):735-7. doi: 10.1002/bjs.1800581006. No abstract available.</citation>
    <PMID>5097949</PMID>
  </reference>
  <reference>
    <citation>Lennard-Jones JE, Stalder GA. Prognosis after resection of chronic regional ileitis. Gut. 1967 Aug;8(4):332-6. doi: 10.1136/gut.8.4.332. No abstract available.</citation>
    <PMID>6039720</PMID>
  </reference>
  <reference>
    <citation>Greenstein AJ, Sachar DB, Pasternack BS, Janowitz HD. Reoperation and recurrence in Crohn's colitis and ileocolitis Crude and cumulative rates. N Engl J Med. 1975 Oct 2;293(14):685-90. doi: 10.1056/NEJM197510022931403.</citation>
    <PMID>1160935</PMID>
  </reference>
  <reference>
    <citation>Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31.</citation>
    <PMID>19109962</PMID>
  </reference>
  <reference>
    <citation>Cottone M, Mocciaro F, Orlando A. Infliximab prevents Crohn's disease recurrence after ileal resection. Expert Rev Gastroenterol Hepatol. 2009 Jun;3(3):231-4. doi: 10.1586/egh.09.13. No abstract available.</citation>
    <PMID>19485805</PMID>
  </reference>
  <reference>
    <citation>Schreiber S. Certolizumab pegol for the treatment of Crohn's disease. Therap Adv Gastroenterol. 2011 Nov;4(6):375-89. doi: 10.1177/1756283X11413315.</citation>
    <PMID>22043230</PMID>
  </reference>
  <reference>
    <citation>Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.</citation>
    <PMID>21642014</PMID>
  </reference>
  <reference>
    <citation>Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.</citation>
    <PMID>21223344</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>September 13, 2017</results_first_submitted>
  <results_first_submitted_qc>September 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 10, 2017</results_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>David B. Stewart, MD, FACS, FASCRS</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>certolizumab</keyword>
  <keyword>mesalamine</keyword>
  <keyword>recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mesalamine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cimzia Treatment Arm</title>
          <description>Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.&#xD;
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>Mesalamine Treatment Arm</title>
          <description>Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.&#xD;
Mesalamine: mesalamine 800 mg orally three times daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>screen failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cimzia Treatment Arm</title>
          <description>Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.&#xD;
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>Mesalamine Treatment Arm</title>
          <description>Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.&#xD;
Mesalamine: mesalamine 800 mg orally three times daily</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Recurrence Rates of Crohn's Disease</title>
        <description>To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.</description>
        <time_frame>4 weeks, 3 months, 6 months, 9 months, and 12 months</time_frame>
        <population>Subjects who received CDAI questionnaire. Number of participants fluctuates due to withdrawals and missed appointments.</population>
        <group_list>
          <group group_id="O1">
            <title>Cimzia Treatment Arm</title>
            <description>Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.&#xD;
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Mesalamine Treatment Arm</title>
            <description>Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.&#xD;
Mesalamine: mesalamine 800 mg orally three times daily</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Recurrence Rates of Crohn's Disease</title>
          <description>To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.</description>
          <population>Subjects who received CDAI questionnaire. Number of participants fluctuates due to withdrawals and missed appointments.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4 week CDAI recurrence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month CDAI reccurence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month CDAI recurrence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 month CDAI recurrence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month CDAI recurrence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Endoscopic Recurrence of Crohn's Disease</title>
        <description>To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.</description>
        <time_frame>One year following enrollment</time_frame>
        <population>Subjects available for colonoscopy at 12 month visit. This visit was sometimes separated from the overall 12-month visit so only 1 (cimzia) and 2 (mesalamine) patients respectively had the colonoscopy performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Cimzia Treatment Arm</title>
            <description>Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.&#xD;
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Mesalamine Treatment Arm</title>
            <description>Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.&#xD;
Mesalamine: mesalamine 800 mg orally three times daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Endoscopic Recurrence of Crohn's Disease</title>
          <description>To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.</description>
          <population>Subjects available for colonoscopy at 12 month visit. This visit was sometimes separated from the overall 12-month visit so only 1 (cimzia) and 2 (mesalamine) patients respectively had the colonoscopy performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cimzia Treatment Arm</title>
          <description>Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.&#xD;
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks</description>
        </group>
        <group group_id="E2">
          <title>Mesalamine Treatment Arm</title>
          <description>Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.&#xD;
Mesalamine: mesalamine 800 mg orally three times daily</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Episcleritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>ulcer (anastamotic)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>melena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>fecal calprotectin elevation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>colon inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>cramping with BM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Crohn's flare</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Elevated CRP</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal ache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Attention Deficit</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>panic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>upper respiratory infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>pulmonary nodules</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Perianal rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>papular rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. David Stewart</name_or_title>
      <organization>Milton S. Hershey Medical Center</organization>
      <phone>717-531-0003</phone>
      <email>dstewart@pennstatehealth.psu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01696942
org study id: 36497
nct id: NCT01696942
lead sponsor: 
collaborator: 
has dmc: Yes
Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates
      compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy
      for Crohn's disease.

        1. To evaluate the difference in clinical recurrence rates between certolizumab and
           mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following
           ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI).

        2. To compare the endoscopic recurrence rates at one year following surgery between
           patients treated with certolizumab and mesalamine.

        3. To compare medication side-effects and tolerance of therapy, including the need to
           interrupt therapy due to side-effects, the incidence of opportunistic infections, and a
           general assessment of each patient's health and well-being using the short-form 36
           (SF-36).
Crohn's disease is an autoimmune, pan-intestinal disease which can affect any portion of the
      alimentary tract, but which has a preference for the small intestine, the colon, and the
      anus. It is now well established that Crohn's disease most commonly presents with an
      ileocolic distribution, followed by involvement of the small intestine, the colon, and the
      anus. Treatment for Crohn's disease is principally medical, reserving surgery to address
      complications from the disease which cannot be adequately resolved with medication alone. The
      single greatest challenge in treating this incurable disease is dealing with its recurrence
      rate. The cumulative probability of disease recurrence is quite high, with 75% of Crohn's
      patients requiring abdominal surgery at some point during their life.

      Following surgery, recurrence rates are significant, varying depending on the manner in which
      recurrence is defined. With regard to clinical recurrences, where the recrudescence of the
      disease is associated with symptoms caused by new intestinal lesions, the recurrence rate is
      10-20% per year.In some instances, clinical recurrences can appear within 3 months of
      surgery. Taking into account the need for additional surgery as defining a "surgical
      recurrence", reoperation rates for Crohn's disease range from 16% to 65% 10 years after a
      previous surgery. When recurrence is viewed from the vantage point of evidence of new Crohn's
      disease activity based on radiographic studies, radiographic recurrences range from 41-60%
      over the first 10 years following surgery. One of the most common measures of recurrence has
      become demonstrating evidence of new Crohn's disease activity based on colonoscopy. This
      endoscopic recurrence has consistently been shown to be as high as 50-75% at 3 months after
      surgery, and 50-90% at 12 months. It is widely accepted by physicians treating Crohn's
      patients that the appearance of endoscopic lesions has prognostic significance, as endoscopic
      evidence of Crohn's disease temporally precedes radiographic, clinical and surgical
      recurrences.

      The role that Cimzia should play in preventing recurrence of Crohn's disease following
      ileocolectomy for Crohn's disease remains to be determined, as does its relative advantages
      and disadvantages compared to the use of mesalamine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical Recurrence Rates of Crohn's Disease
time frame: 4 weeks, 3 months, 6 months, 9 months, and 12 months
description: To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.
measure: Number of Participants With Endoscopic Recurrence of Crohn's Disease
time frame: One year following enrollment
description: To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.
arm group label: Cimzia treatment arm
arm group type: Experimental
description: Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
arm group label: Mesalamine treatment arm
arm group type: Active Comparator
description: Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
intervention type: Drug
intervention name: Cimzia
description: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
arm group label: Cimzia treatment arm
other name: Certolizumab
intervention type: Drug
intervention name: Mesalamine
description: mesalamine 800 mg orally three times daily
arm group label: Mesalamine treatment arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David B Stewart, MD
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
citation: Whelan G, Farmer RG, Fazio VW, Goormastic M. Recurrence after surgery in Crohn's disease. Relationship to location of disease (clinical pattern) and surgical indication. Gastroenterology. 1985 Jun;88(6):1826-33. doi: 10.1016/0016-5085(85)90007-1.
PMID: 3996839
citation: Mekhjian HS, Switz DM, Watts HD, Deren JJ, Katon RM, Beman FM. National Cooperative Crohn's Disease Study: factors determining recurrence of Crohn's disease after surgery. Gastroenterology. 1979 Oct;77(4 Pt 2):907-13. No abstract available.
PMID: 467942
citation: Kyle J. Prognosis after ileal resection for Crohn's disease. Br J Surg. 1971 Oct;58(10):735-7. doi: 10.1002/bjs.1800581006. No abstract available.
PMID: 5097949
citation: Lennard-Jones JE, Stalder GA. Prognosis after resection of chronic regional ileitis. Gut. 1967 Aug;8(4):332-6. doi: 10.1136/gut.8.4.332. No abstract available.
PMID: 6039720
citation: Greenstein AJ, Sachar DB, Pasternack BS, Janowitz HD. Reoperation and recurrence in Crohn's colitis and ileocolitis Crude and cumulative rates. N Engl J Med. 1975 Oct 2;293(14):685-90. doi: 10.1056/NEJM197510022931403.
PMID: 1160935
citation: Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31.
PMID: 19109962
citation: Cottone M, Mocciaro F, Orlando A. Infliximab prevents Crohn's disease recurrence after ileal resection. Expert Rev Gastroenterol Hepatol. 2009 Jun;3(3):231-4. doi: 10.1586/egh.09.13. No abstract available.
PMID: 19485805
citation: Schreiber S. Certolizumab pegol for the treatment of Crohn's disease. Therap Adv Gastroenterol. 2011 Nov;4(6):375-89. doi: 10.1177/1756283X11413315.
PMID: 22043230
citation: Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.
PMID: 21642014
citation: Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
PMID: 21223344
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: David B. Stewart, MD, FACS, FASCRS
investigator title: Assistant Professor of Surgery
mesh term: Crohn Disease
mesh term: Recurrence
mesh term: Mesalamine
participant flow: 
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reported events: 
certain agreements: 
point of contact: 