<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/NCT03251118</url>
  </required_header>
  <id_info>
    <org_study_id>TARGET-IBD</org_study_id>
    <nct_id>NCT03251118</nct_id>
  </id_info>
  <brief_title>A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease</brief_title>
  <acronym>TARGET-IBD</acronym>
  <official_title>A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Target PharmaSolutions, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Target PharmaSolutions, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients&#xD;
      (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical&#xD;
      practice. TARGET-IBD will create a research registry of patients with IBD within academic and&#xD;
      community real-world practices in order to assess the safety and effectiveness of current and&#xD;
      future therapies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Natural history of Inflammatory Bowel Disease: Characteristics of IBD</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of Inflammatory Bowel Disease: Participant demographics</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of Inflammatory Bowel Disease: Treatment use</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of Inflammatory Bowel Disease: Treatment response</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural history of Inflammatory Bowel Disease: Disease progression</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endoscopic measures of mucosal healing</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event frequency and severity</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timepoint of clinical response</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timepoint of endoscopic response</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for treatment discontinuation</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported patient health measures: EQ-5D</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported patient health measures: PRO-2 for Crohn's Disease</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported patient health measures: PRO-2 for Ulcerative colitis</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported patient health measures: 2-question Adherence Measure</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported patient health measures: Manitoba IBD Index (MIBDI)</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)</measure>
    <time_frame>Every 3 months for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timepoint of endoscopic remission</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">15000</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Crohn's Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Indeterminate Colitis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients enrolled in TARGET-IBD may be invited to participate in the Biorepository Bank&#xD;
      (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and&#xD;
      participation in this project will not affect participation in the main study. These samples&#xD;
      will be shipped to a central repository for storage to use in future studies. Samples stored&#xD;
      at the biorepository will be identified only with the participant's unique study ID number&#xD;
      and the date the sample was obtained. The link between the participant's study ID number and&#xD;
      their name will be available only at the site where the samples were obtained.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults and children (age 2 or older) with a diagnosis of Crohn's disease, Ulcerative&#xD;
        colitis, or Indeterminate colitis having been prescribed any IBD treatment outside of a&#xD;
        clinical trial&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD),&#xD;
             Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any&#xD;
             IBD treatment (initial or subsequent) outside of a clinical trial.&#xD;
&#xD;
          2. Have plans for future visits at the site for continued management of IBD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to provide written informed consent/assent.&#xD;
&#xD;
          2. Being enrolled in any interventional study or trial for IBD treatment. Note: Patient&#xD;
             may be enrolled in other registries or studies where IBD treatment outcomes are&#xD;
             observed and/or reported (such as center-based registries).&#xD;
&#xD;
          3. Prior total abdominal colectomy for UC or IBDU.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Laura Dalfonso</last_name>
    <phone>9842340268</phone>
    <email>ldalfonso@targetpharmasolutions.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Om Research</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>FACEY Medical Foundation</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of California - Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandeep Dhaliwal</last_name>
      <email>sandhaliwal@UCDAVIS.EDU</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janet Cunningham</last_name>
      <phone>650-724-7186</phone>
      <email>jcunning@stanford.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brooke Feight</last_name>
      <phone>303-724-4396</phone>
      <email>Brooke.Feight@cuanschutz.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33762</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shannon Brewington</last_name>
      <email>sbrewington@gastrofl.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Jacksonville-Gastroenterology</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Advanced Gastroenterology Associates, LLC</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanne Root</last_name>
      <email>research@advancedgastro.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastro</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quin Shaw</last_name>
      <email>quin.shaw@atlantagastro.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marian Fernando</last_name>
      <email>mfernando5@bsd.uchicago.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Indianapolis Gastroenterology Research Foundation</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jena Neuhaus</last_name>
      <phone>319-335-0123</phone>
      <email>jena-neuhaus@uiowa.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </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>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Michigan Medical Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jermaine Bester</last_name>
      <phone>734-647-1092</phone>
      <email>jbester@med.umich.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Freebersyser</last_name>
      <email>jan.freebersyser@health.slu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carol Carney</last_name>
      <email>ccarney@unmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03755</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace Tomasetti</last_name>
      <email>Grace.E.Tomasetti@hitchcock.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rutgers, Robert Wood Johnson Medical School</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at Montefiore</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gitit Tomer, MD</last_name>
      <email>gitomer@montefiore.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnold Myrtaj</last_name>
      <phone>646-501-7822</phone>
      <email>arnold.myrtaj@nyulangone.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mount Sinai, Icahn School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josephine Mitcham</last_name>
      <phone>212-824-7797</phone>
      <email>josephine.mitcham@mountsinai.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group of the Hudson Valley</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Cary Gastroenterology Associates</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Jackson</last_name>
      <email>susan_jackson@med.unc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System-Center for Digestive Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamie Crawford</last_name>
      <phone>704-355-0282</phone>
      <email>jamie.crawford@atriumhealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Digestive Health Specialists, PA</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic/DIgestive Disease and Surgery Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin Hricik</last_name>
      <phone>216-444-3105</phone>
      <email>hricikk@ccf.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jody Riley</last_name>
      <phone>614-685-3750</phone>
      <email>jody.riley@osumc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Starr</last_name>
      <phone>215-349-8527</phone>
      <email>jstarr@pennmedicine.upenn.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Motley</last_name>
      <phone>615-322-6281</phone>
      <email>amy.motley@vumc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UT Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary-Joe Touma</last_name>
      <email>mary-joe.touma@utsouthwestern.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason K Hou</last_name>
      <phone>713-798-8820</phone>
      <email>jkhou@bcm.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>MultiCare Institute for Research and Innovation</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital &amp; Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Zentz</last_name>
      <email>ezentz@medicine.wisc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Hannah Ranous</last_name>
      <phone>608-262-1295</phone>
      <email>jmranous@medicine.wisc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <keyword>Ulcerative colitis</keyword>
  <keyword>Indeterminate colitis</keyword>
  <keyword>Digestive System Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251118
org study id: TARGET-IBD
nct id: NCT03251118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients
      (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical
      practice. TARGET-IBD will create a research registry of patients with IBD within academic and
      community real-world practices in order to assess the safety and effectiveness of current and
      future therapies.
observational model: Cohort
time perspective: Other
measure: Natural history of Inflammatory Bowel Disease: Characteristics of IBD
time frame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Participant demographics
time frame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Treatment use
time frame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Treatment response
time frame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Disease progression
time frame: Up to 5 years
measure: Endoscopic measures of mucosal healing
time frame: Up to 5 years
measure: Adverse event frequency and severity
time frame: Every 3 months for 5 years
measure: Timepoint of clinical response
time frame: Every 3 months for 5 years
measure: Timepoint of endoscopic response
time frame: Up to 5 years
measure: Reasons for treatment discontinuation
time frame: Up to 5 years
measure: Self-reported patient health measures: EQ-5D
time frame: Every 3 months for 5 years
measure: Self-reported patient health measures: PRO-2 for Crohn's Disease
time frame: Every 3 months for 5 years
measure: Self-reported patient health measures: PRO-2 for Ulcerative colitis
time frame: Every 3 months for 5 years
measure: Self-reported patient health measures: 2-question Adherence Measure
time frame: Every 3 months for 5 years
measure: Self-reported patient health measures: Manitoba IBD Index (MIBDI)
time frame: Every 3 months for 5 years
measure: Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)
time frame: Every 3 months for 5 years
measure: Timepoint of endoscopic remission
time frame: Up to 5 years
Patients enrolled in TARGET-IBD may be invited to participate in the Biorepository Bank
      (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and
      participation in this project will not affect participation in the main study. These samples
      will be shipped to a central repository for storage to use in future studies. Samples stored
      at the biorepository will be identified only with the participant's unique study ID number
      and the date the sample was obtained. The link between the participant's study ID number and
      their name will be available only at the site where the samples were obtained.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Laura Dalfonso
phone: 9842340268
email: ldalfonso@targetpharmasolutions.com
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Terminated
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No