Cohort Study of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Tertiary Referral Hospital Setting in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 368
- 主要终点
- Total Number of Relapses in Year 1
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is newly diagnosed with moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks prior to enrollment
- •The diagnosis was based on symptoms consistent with ulcerative colitis lasting for more than 4 weeks, excluding infections and other acute or chronic non-infectious bowel syndrome conditions
- •Participants meet diagnostic criteria for ulcerative colitisif at least 3 out of 4 of the following are met: 1) A History of diarrhea and/or blood/pus in stool, 2) Macroscopic appearance at endoscopy, with continuous mucosal inflammation affecting the rectum in continuity with some or all of the colon, 3) Microscopic features on biopsy consistent with ulcerative colitis, 4) No suspicion of Crohn's disease or indeterminate colitis
- •Participants are willing to participate in regular follow-up visits
- •Participant is willing to participate in the study and has signed the informed consent
排除标准
- •Participants in an interventional clinical trial with systemic corticosteroid, biologics (including, but not limited to, infliximab, golimumab, adalimumab and vedolizumab, etc) and other drugs (sulfasalazine, medalamine, azathioprine, tofacitinib, etc) for ulcerative colitis
- •Having experienced colectomy such as subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis, or planning surgical treatment within 1 year from enrollment
- •A current diagnosis of indeterminate colitis, or current diagnosis or history of Crohn's disease
结局指标
主要结局
Total Number of Relapses in Year 1
时间窗: 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).
Percentage of Participants With Sustained Remission in Year 1
时间窗: Year 1
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).
Percentage of Participants With Sustained Remission in Year 3
时间窗: Year 3
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).
Total Number of Relapses in Year 3
时间窗: 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
时间窗: 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 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).
Percentage of Participants With Sustained Remission in Year 5
时间窗: Year 5
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).
次要结局
- Total Number of Ulcerative Colitis-Related Hospitalizations(Year 3 and 5)
- Total Days of Ulcerative Colitis-Related Hospitalizations(Year 3 and 5)
- Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Year 1, 3 and 5(Baseline and Year 1, 3 and 5)
- Mean Time to Relapse(Year 1, 3 and 5)
- Percentage of Participants With Sustained Clinical Response(Year 1, 3 and 5)
- Percentage of Participants With Colectomy(Year 3 and 5)
- Percentage of Participants With Death(Year 3 and 5)
- Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction(Baeline up to Year 5)
- Mean Change From Baseline in Disease Extent at Year 1, 3 and 5(Baseline, Year 1, 3 and 5)
- Mean Change From Baseline in Short Form Survey (SF 12) Score at Year 1, 3 and 5(Baseline, Year 1, 3 and 5)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Year 1, 3 and 5(Baseline, Year 1, 3 and 5)
- Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics(Baseline up to Year 5)
- Mean Time to First Treatment With Immune Modulators, Systemic Steroids and Biologics From Baseline(Baseline up to Year 5)