<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/NCT02229344</url>
  </required_header>
  <id_info>
    <org_study_id>CR103116</org_study_id>
    <secondary_id>REMICADECRD4016</secondary_id>
    <secondary_id>INF-KOR-5005</secondary_id>
    <nct_id>NCT02229344</nct_id>
  </id_info>
  <brief_title>Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea</brief_title>
  <acronym>MOSAIK</acronym>
  <official_title>Cohort Study of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Tertiary Referral Hospital Setting in Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Korea, Ltd., Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Korea, Ltd., Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe clinical course of newly diagnosed moderate to&#xD;
      severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral&#xD;
      hospitals in Korea for 5-year follow-up under usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter (when medical research study takes place in more than one country),&#xD;
      prospective (study following participants forward in time), disease-oriented and&#xD;
      hospital-based 5-year follow-up longitudinal study in Korean participants with newly&#xD;
      diagnosed moderate to severe ulcerative colitis who visit tertiary referral hospital. As the&#xD;
      study is observational in nature, no intervention will be received by participants. Efficacy&#xD;
      will primarily be assessed by number of relapses and percentage of participants achieving&#xD;
      sustained remission (clinical, endoscopic and combined remission).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">February 22, 2022</completion_date>
  <primary_completion_date type="Actual">February 22, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total Number of Relapses in Year 1</measure>
    <time_frame>Year 1</time_frame>
    <description>Relapse is defined as increase in Mayo or partial Mayo score of more than or equal to (&gt;=) 3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (less than or equal to [&lt;=] 1 relapse per year), frequent pattern (&gt;=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Number of Relapses in Year 3</measure>
    <time_frame>Year 3</time_frame>
    <description>Relapse is defined as increase in Mayo or partial Mayo score of &gt;=3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (&lt;=1 relapse per year), frequent pattern (&gt;=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Number of Relapses in Year 5</measure>
    <time_frame>Year 5</time_frame>
    <description>Relapse is defined as increase in Mayo or partial Mayo score of &gt;=3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (&lt;=1 relapse per year), frequent pattern (&gt;=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Remission in Year 1</measure>
    <time_frame>Year 1</time_frame>
    <description>Clinical remission is &lt;=2 points with no individual sub-score &gt;1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Remission in Year 3</measure>
    <time_frame>Year 3</time_frame>
    <description>Clinical remission is &lt;=2 points with no individual sub-score &gt;1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Remission in Year 5</measure>
    <time_frame>Year 5</time_frame>
    <description>Clinical remission is &lt;=2 points with no individual sub-score &gt;1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Time to Relapse</measure>
    <time_frame>Year 1, 3 and 5</time_frame>
    <description>Relapse is defined as increase in mayo or partial Mayo score of more than or equal to (&gt;=) 3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Average time taken to occurrence of first relapse will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Clinical Response</measure>
    <time_frame>Year 1, 3 and 5</time_frame>
    <description>Response is defined as decrease in Mayo or partial Mayo score of &gt;=3 points from Baseline and decrease in Mayo score of &gt;=30 percent (%) from Baseline and decrease in the rectal bleeding score &gt;=1 or an absolute rectal bleeding score of 0 or 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Ulcerative Colitis-Related Hospitalizations</measure>
    <time_frame>Year 3 and 5</time_frame>
    <description>Total number of ulcerative colitis-related hospitalizations will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Days of Ulcerative Colitis-Related Hospitalizations</measure>
    <time_frame>Year 3 and 5</time_frame>
    <description>Total days of ulcerative colitis-related hospitalizations will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Colectomy</measure>
    <time_frame>Year 3 and 5</time_frame>
    <description>Percentage of participants who will be going for surgery to remove part or all of the colon will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Death</measure>
    <time_frame>Year 3 and 5</time_frame>
    <description>Percentage of participants with death (ulcerative colitis related and non-ulcerative colitis related) will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Disease Extent at Year 1, 3 and 5</measure>
    <time_frame>Baseline, Year 1, 3 and 5</time_frame>
    <description>Colonoscopy (a medical examination of the colon by a physician using a colonoscope) will be conducted to explore the extent of lesion to determine extent of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Year 1, 3 and 5</measure>
    <time_frame>Baseline and Year 1, 3 and 5</time_frame>
    <description>The IBDQ evaluates the effect of the participants' inflammatory bowel disease on the quality of life Scores range from 32 to 224 with higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Short Form Survey (SF 12) Score at Year 1, 3 and 5</measure>
    <time_frame>Baseline, Year 1, 3 and 5</time_frame>
    <description>The SF12 is a generic measure physical and mental health, it is is weighted and summed to provide easily interpretable scales. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Year 1, 3 and 5</measure>
    <time_frame>Baseline, Year 1, 3 and 5</time_frame>
    <description>The HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, and each item is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics</measure>
    <time_frame>Baseline up to Year 5</time_frame>
    <description>Percentage of participants treated with immune modulators (azathioprine or 6-mercaptoprine at least a consecutive 3-month course), systemic steroids and biologics will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time to First Treatment With Immune Modulators, Systemic Steroids and Biologics From Baseline</measure>
    <time_frame>Baseline up to Year 5</time_frame>
    <description>Time to first administration of immune modulators like azathioprine or 6-mercaptoprine for at least a consecutive 3-month course, systemic steroids and biologics from Baseline will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction</measure>
    <time_frame>Baeline up to Year 5</time_frame>
    <description>Number of participants with CAM use and satisfaction will be reported.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">368</enrollment>
  <condition>Colitis, Ulcerative</condition>
  <arm_group>
    <arm_group_label>Newly Diagnosed Moderate to Severe Ulcerative Colitis</arm_group_label>
    <description>Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.</description>
    <arm_group_label>Newly Diagnosed Moderate to Severe Ulcerative Colitis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood sample will be collected and stored for genetic and biomarker research from&#xD;
      participants who agree to give additional informed consent form.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary&#xD;
        referral hospital within 4 weeks before prior to enrollment will be observed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is newly diagnosed with moderate to severe ulcerative colitis in a&#xD;
             tertiary referral hospital within 4 weeks prior to enrollment&#xD;
&#xD;
          -  The diagnosis was based on symptoms consistent with ulcerative colitis lasting for&#xD;
             more than 4 weeks, excluding infections and other acute or chronic non-infectious&#xD;
             bowel syndrome conditions&#xD;
&#xD;
          -  Participants meet diagnostic criteria for ulcerative colitisif at least 3 out of 4 of&#xD;
             the following are met: 1) A History of diarrhea and/or blood/pus in stool, 2)&#xD;
             Macroscopic appearance at endoscopy, with continuous mucosal inflammation affecting&#xD;
             the rectum in continuity with some or all of the colon, 3) Microscopic features on&#xD;
             biopsy consistent with ulcerative colitis, 4) No suspicion of Crohn's disease or&#xD;
             indeterminate colitis&#xD;
&#xD;
          -  Participants are willing to participate in regular follow-up visits&#xD;
&#xD;
          -  Participant is willing to participate in the study and has signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants in an interventional clinical trial with systemic corticosteroid,&#xD;
             biologics (including, but not limited to, infliximab, golimumab, adalimumab and&#xD;
             vedolizumab, etc) and other drugs (sulfasalazine, medalamine, azathioprine,&#xD;
             tofacitinib, etc) for ulcerative colitis&#xD;
&#xD;
          -  Having experienced colectomy such as subtotal colectomy with ileorectostomy or&#xD;
             colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis, or&#xD;
             planning surgical treatment within 1 year from enrollment&#xD;
&#xD;
          -  A current diagnosis of indeterminate colitis, or current diagnosis or history of&#xD;
             Crohn's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Korea, Ltd., Korea Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Korea, Ltd., Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Ansan-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cheonan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cheongju-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guri-Si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iksan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kwanju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seongnam-Si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colitis, ulcerative</keyword>
  <keyword>MOSAIK</keyword>
  <keyword>REMICADE</keyword>
  <keyword>Infliximab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- 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/NCT02229344
org study id: CR103116
secondary id: REMICADECRD4016
secondary id: INF-KOR-5005
nct id: NCT02229344
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to describe clinical course of newly diagnosed moderate to
      severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral
      hospitals in Korea for 5-year follow-up under usual care.
This is a multicenter (when medical research study takes place in more than one country),
      prospective (study following participants forward in time), disease-oriented and
      hospital-based 5-year follow-up longitudinal study in Korean participants with newly
      diagnosed moderate to severe ulcerative colitis who visit tertiary referral hospital. As the
      study is observational in nature, no intervention will be received by participants. Efficacy
      will primarily be assessed by number of relapses and percentage of participants achieving
      sustained remission (clinical, endoscopic and combined remission).
observational model: Cohort
time perspective: Prospective
measure: Total Number of Relapses in Year 1
time frame: Year 1
description: Relapse is defined as increase in Mayo or partial Mayo score of more than or equal to (>=) 3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (less than or equal to [<=] 1 relapse per year), frequent pattern (>=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).
measure: Total Number of Relapses in Year 3
time frame: Year 3
description: Relapse is defined as increase in Mayo or partial Mayo score of >=3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (<=1 relapse per year), frequent pattern (>=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).
measure: Total Number of Relapses in Year 5
time frame: Year 5
description: Relapse is defined as increase in Mayo or partial Mayo score of >=3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (<=1 relapse per year), frequent pattern (>=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).
measure: Percentage of Participants With Sustained Remission in Year 1
time frame: Year 1
description: Clinical remission is <=2 points with no individual sub-score >1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).
measure: Percentage of Participants With Sustained Remission in Year 3
time frame: Year 3
description: Clinical remission is <=2 points with no individual sub-score >1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).
measure: Percentage of Participants With Sustained Remission in Year 5
time frame: Year 5
description: Clinical remission is <=2 points with no individual sub-score >1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).
measure: Mean Time to Relapse
time frame: Year 1, 3 and 5
description: Relapse is defined as increase in mayo or partial Mayo score of more than or equal to (>=) 3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Average time taken to occurrence of first relapse will be observed.
measure: Percentage of Participants With Sustained Clinical Response
time frame: Year 1, 3 and 5
description: Response is defined as decrease in Mayo or partial Mayo score of >=3 points from Baseline and decrease in Mayo score of >=30 percent (%) from Baseline and decrease in the rectal bleeding score >=1 or an absolute rectal bleeding score of 0 or 1.
measure: Total Number of Ulcerative Colitis-Related Hospitalizations
time frame: Year 3 and 5
description: Total number of ulcerative colitis-related hospitalizations will be observed.
measure: Total Days of Ulcerative Colitis-Related Hospitalizations
time frame: Year 3 and 5
description: Total days of ulcerative colitis-related hospitalizations will be observed.
measure: Percentage of Participants With Colectomy
time frame: Year 3 and 5
description: Percentage of participants who will be going for surgery to remove part or all of the colon will be observed.
measure: Percentage of Participants With Death
time frame: Year 3 and 5
description: Percentage of participants with death (ulcerative colitis related and non-ulcerative colitis related) will be observed.
measure: Mean Change From Baseline in Disease Extent at Year 1, 3 and 5
time frame: Baseline, Year 1, 3 and 5
description: Colonoscopy (a medical examination of the colon by a physician using a colonoscope) will be conducted to explore the extent of lesion to determine extent of disease.
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Year 1, 3 and 5
time frame: Baseline and Year 1, 3 and 5
description: The IBDQ evaluates the effect of the participants' inflammatory bowel disease on the quality of life Scores range from 32 to 224 with higher scores indicating better quality of life.
measure: Mean Change From Baseline in Short Form Survey (SF 12) Score at Year 1, 3 and 5
time frame: Baseline, Year 1, 3 and 5
description: The SF12 is a generic measure physical and mental health, it is is weighted and summed to provide easily interpretable scales. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Year 1, 3 and 5
time frame: Baseline, Year 1, 3 and 5
description: The HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, and each item is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
measure: Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics
time frame: Baseline up to Year 5
description: Percentage of participants treated with immune modulators (azathioprine or 6-mercaptoprine at least a consecutive 3-month course), systemic steroids and biologics will be reported.
measure: Mean Time to First Treatment With Immune Modulators, Systemic Steroids and Biologics From Baseline
time frame: Baseline up to Year 5
description: Time to first administration of immune modulators like azathioprine or 6-mercaptoprine for at least a consecutive 3-month course, systemic steroids and biologics from Baseline will be observed.
measure: Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction
time frame: Baeline up to Year 5
description: Number of participants with CAM use and satisfaction will be reported.
arm group label: Newly Diagnosed Moderate to Severe Ulcerative Colitis
description: Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.
intervention type: Other
intervention name: No Intervention
description: Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.
arm group label: Newly Diagnosed Moderate to Severe Ulcerative Colitis
Blood sample will be collected and stored for genetic and biomarker research from
      participants who agree to give additional informed consent form.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Korea, Ltd., Korea Clinical Trial
role: Study Director
affiliation: Janssen Korea, Ltd., Korea
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer