Real-world Data of Moderate to Severe Inflammatory Bowel Disease (UC and CD) in Mexico: a Multicenter, Non-interventional Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Patient Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Active CD at Day 1
研究概览
简要总结
The main aim of this study is to check the disease activity in people with moderate to severe ulcerative colitis and Crohn's disease.
Participants will complete questionnaires about their disease and quality of life on Day 1 clinic visit. They will do this during a standard scheduled appointment with their doctor. Some of this study will also involve collecting information about participants from their medical records.
详细描述
This is a retrospective, cross-sectional, and non-interventional study of participants with moderate to severe IBD (UC or CD). The study will have a cross-sectional evaluation on Day 1 to provide the real-world data of disease activity, treatment patterns, burden of disease and quality of life in participants with moderate to severe UC or CD.
The study will involve an additional retrospective review of medical charts of participants of previous 3 years to describe the IBD treatments and use of other healthcare resources related with the management of UC or DC.
The study will enroll approximately 335 participants. All participants will be enrolled in one observational cohort.
This multi-center trial will be conducted in Mexico. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with moderate to severe CD or UC established for at least 6 months prior to Day 1 appointment, based on clinical, endoscopic or image criteria.
- •Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD).
排除标准
- •Has indeterminate or not classified colitis.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
结局指标
主要结局
Percentage of Participants With Active CD at Day 1
时间窗: Day 1
Percentage of participants with active CD observed, where active CD was defined as Harvey Bradshaw index (HBI) greater than or equal to (\>=) 8 or Crohn's disease active index (CDAI) \>=220. CDAI assessed CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI score was used to measure disease activity of CD and consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicate more severe disease. Percentages are rounded off to whole number at the nearest decimal.
Percentage of Participants With Active UC at Day 1
时间窗: Day 1
Percentage of participants with active disease UC disease will be observed, where UC is defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score is composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0 to 2), having mild activity (pMayo of 3 or 4) or moderate to severe activity (pMayo of \>=5).
次要结局
- Number of Participants With CD Based on Clinical Presentation(Day 1)
- Number of Participants With UC Based on Clinical Presentation(Day 1)
- Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies(From 3 years prior to Day 1 until Day 1)
- Duration of IBD Therapies(From 3 years prior to Day 1 until Day 1)
- Percentage of Participants With UC or CD Based on Biologic-experience(From 3 years prior to Day 1 until Day 1)
- Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies(From 3 years prior to Day 1 until Day 1)
- Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies(From 3 years prior to Day 1 until Day 1)
- Number of Participants With UC or CD Introduced With IBD Treatment at Day 1(Day 1)
- Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants(Day 1)
- Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants(Day 1)
- Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants(Day 1)
- Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants(Day 1)
- Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants(The last 7 days prior to Day 1)
- Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants(The last 7 days prior to Day 1)
- Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants(The last 7 days prior to Day 1)
- Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants(The last 7 days prior to Day 1)
- Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work(Day 1)
- Percentage of Participants With UC or CD Categorized Based on Healthcare Resources(From 3 years prior to Day 1 until Day 1)
- Total Direct Medical Cost for Participants With UC or CD(From 3 years prior to Day 1 until Day 1)
- Indirect Cost for Participants With UC or CD(From 3 years prior to Day 1 until Day 1)