Clinical Trial: Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Cohort Study of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Tertiary Referral Hospital Setting in Korea

Brief Summary: 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.

Detailed Summary: 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).
Sponsor: Janssen Korea, Ltd., Korea

Current Primary Outcome:

  • Total Number of Relapses in Year 1 [ Time Frame: Year 1 ]
    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).
  • Total Number of Relapses in Year 3 [ Time Frame: Year 3 ]
    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).
  • Total Number of Relapses in Year 5 [ Time Frame: Year 5 ]
    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 categori

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Mean Time to Relapse [ Time Frame: Year 1, 3 and 5 ]
      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.
    • Percentage of Participants With Sustained Clinical Response [ Time Frame: Year 1, 3 and 5 ]
      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.
    • Total Number of Ulcerative Colitis-Related Hospitalizations [ Time Frame: Year 3 and 5 ]
      Total number of ulcerative colitis-related hospitalizations will be observed.
    • Total Days of Ulcerative Colitis-Related Hospitalizations [ Time Frame: Year 3 and 5 ]
      Total days of ulcerative colitis-related hospitalizations will be observed.
    • Percentage of Participants With Colectomy [ Time Frame: Year 3 and 5 ]
      Percentage of participants who will be going for surgery to remove part or all of the colon will be observed.
    • Percentage of Participants With Death [ Time Frame: Year 3 and 5 ]
      Percentage of participants with death (ulcerative colitis related and non-ulcerative colitis related) will be observed.
    • Mean Change From Baseline in Disease Extent at Year 1, 3 and 5 [ Time Frame: Baseline, Year 1, 3 and 5 ]
      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.
    • 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 ]
      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.
    • 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 ]
      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.
    • 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 ]
      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.
    • Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics [ Time Frame: Baseline up to Year 5 ]
      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.
    • Mean Time to First Treatment With Immune Modulators, Systemic Steroids and Biologics From Baseline [ Time Frame: Baseline up to Year 5 ]
      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.
    • Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction [ Time Frame: Baeline up to Year 5 ]
      Number of participants with CAM use and satisfaction will be reported.


    Original Secondary Outcome: Same as current

    Information By: Janssen Korea, Ltd., Korea

    Dates:
    Date Received: August 28, 2014
    Date Started: July 1, 2014
    Date Completion: August 22, 2022
    Last Updated: April 20, 2017
    Last Verified: April 2017