Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Brazil: a Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life (RISE BR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 407
- 主要终点
- Percentage of Participants With Active Crohn's Disease (CD) at Day 1
研究概览
简要总结
The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of available biologic therapies.
详细描述
This is a non-interventional study to determine the rate of control of disease activity in moderate to severe inflammatory bowel disease (IBD) participants, with two parts: cross-sectional evaluation (Day 1) with retrospective data collection and a prospective 12-month evaluation for patients with active IBD at cross-sectional evaluation (Day 1).
The study enrolled 407 patients. This multicenter trial was conducted in Brazil. Retrospective data of previous IBD treatments (drug, dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years will be collected. Prospective data was collected for a period of 12 months in participants with active disease. UC participants, with no or light disease activity at Day 1 did not continue to 12-month follow up. CD participants, with no or light disease activity at Day 1 but with colonoscopy or calprotectin levels (i.e, calprotectin >200 ug/g) in the previous year suggestive of inadequate control of activity progressed to 12-month follow up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •18 years or older (at the time of diagnosis of moderate to severe UC or CD).
- •Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment according the clinical or endoscopic \ criteria.
- •Has provided the written informed consent. For the prospective period, eligible participants should present at least one of the following criteria that will only be applied at Day 1:
- •For CD participants:
- •Harvey Bradshaw Index (HBI) ≥8 or
- •Crohn's Disease Activity Index (CDAI) ≥220 or Considering that for CD participants, the disease activity may not be clearly documented only with clinical data, some objective criteria may be considered as entry criteria for the 12-month prospective period:
- •Colonoscopy in the previous year suggestive of inadequate control of activity or,
- •Calprotectin levels in the previous year suggestive of inadequate control of activity (i.e, calprotectin >200 µg/g).
- •For UC: partial Mayo Score ≥
- •Note: Participants with colostomy and prospective period: Although clinical scales defined above are impacted by colostomy these participants will not be excluded from the protocol to ensure the assessment of different clinical presentations of the IBD. In addition, participants with colostomy must follow the same criteria as above to be eligible to the prospective phase.
排除标准
- •Indeterminate or not classified colitis.
- •Current or previous participation in interventional clinical trial (within the last 3 years). In addition, for the 12-month prospective period, participants will be excluded if:
- •Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Hospitalized participants at Day
- •Current off label treatment with Vedolizumab.
- •Study Discontinuation Criteria It will be considered a premature termination the situation in which the participant discontinues the participation, i.e. they are withdrawn from the study before completing the 12 months of follow up period (365 days ± 14 days from Day 1), due to any of the reasons listed below:
- •Withdrawal of consent: participants who for any reason withdraw the free and informed consent;
- •Lost to follow-up (no return of the participant on the expected date of visit - drop-out from the protocol);
- •Study termination;
- •Any situation that places the participant within one of the exclusion criteria.
- •Note: Participants who are eligible for the prospective period, it means, with active disease at Day 1 but who during the 12 months period presents disease remission and/or no activity disease condition, are allowed to continue the participation in the study.
结局指标
主要结局
Percentage of Participants With Active Crohn's Disease (CD) at Day 1
时间窗: Day 1
Participants with Harvey Bradshaw Index (HBI) score of ≥8 or Crohn´s Disease Activity Index (CDAI) ≥220 points at Day 1 were classified as participants with active disease. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. The CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.
Number of Participants With Active Ulcerative Colitis (UC) at Day 1
时间窗: Day 1
Participants with ≥5 points in Partial Mayo Score were classified as active UC disease. The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).
次要结局
- Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables(Day 1)
- Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1(Day 1)
- Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables(Day 1)
- Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1(Day 1)
- Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years(Within the previous 3 years including Day 1)
- Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies(Day 1)
- Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables(Day 1)
- Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12(Day 1 and Month 12)
- Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years(Within the previous 3 years including Day 1)
- Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12(Day 1 and Month 12)
- Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12(Day 1 and Month 12)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1(Day 1)
- Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1(Day 1)
- Percentage of Participants Who Used Healthcare Resources(Day 1)
- Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables(Day 1)
- Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables(Day 1)
- Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason(Month 12)
- Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1(Day 1)
- Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1(Day 1)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1(Day 1)
- Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1(Day 1)
- Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1(Day 1)
- Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI(Day 1)
- Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables(Day 1)
- Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables(Day 1)