A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 14
- 主要终点
- Percentage of Participants in Clinical Remission at Month 12
研究概览
简要总结
The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab.
详细描述
This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to provide real-world data to describe clinical outcomes and participant-reported symptom experience over 12 months following vedolizumab treatment initiation.
The study will enroll approximately 140 participants. All participants will be enrolled in one observational group:
• Vedolizumab
This multicenter trial will be conducted in Canada. The overall duration of study will be approximately 24 months, including participant's enrolment period of 12 months and follow-up data collection period of 12 months.
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
- •Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
- •Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
- •Scheduled for initial vedolizumab treatment per usual care recommendation.
- •Was biologic-naive at time of initiating vedolizumab treatment.
排除标准
- •Was prescribed vedolizumab as part of a clinical study.
- •Has isolated and active perianal disease in the absence of luminal CD.
结局指标
主要结局
Percentage of Participants in Clinical Remission at Month 12
时间窗: Month 12
Clinical remission is defined as HBI less than or equal to (\<=) 5. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0= very well to 4= terrible), abdominal pain (0=none to 3= severe), number of liquid or soft stools/ previous day, abdominal mass (0= none to 3= definite and tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, where score \<5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (\>) 16 = severe disease activity.
次要结局
- Change From Baseline in HBI at Month 12(Baseline up to Month 12)
- Change From Baseline in Physician Global Assessment (PGA) at Month 12(Baseline up to Month 12)
- Change From Baseline in Patient-reported Outcome (PRO) Using the Two-item (PRO-2) at Month 12(Baseline and Month 12)
- Percentage of Participants in Remission as Determined by CRP Measurements <5 Milligram per Liter (mg/L) at Month 12(Month 12)
- Change From Baseline in Fecal Calprotectin (FCP) Levels at Month 12(Baseline and Month 12)
- Change From Baseline in C-reactive Protein (CRP) Level at Month 12(Baseline and Month 12)
- Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Score at Month 12(Baseline, Month 12)
- Change From Baseline in Immunomodulator Dose at Month 12(Baseline and Month 12)
- Change From Baseline in the Percentage of Participants That are Immunomodulator-free at Month 12(Baseline and Month 12)
- Percentage of Participants in Remission as Determined by FCP Measurements (FCP < 50 milligram per kilogram [mg/Kg]) at Month 12(Month 12)
- Number of Participants Categorized by Participant Demographics, Clinical Characteristics and Disease Phenotype(Month 12)
- Percentage of Participants With Endoscopic Improvement at Month 12 as Determined by Simple Endoscopic Score for Crohn's Disease (SES-CD) Values or Qualitative Physician Assessment of Disease Severity(Baseline and Month 12)
- Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at Month 12(Baseline and Month 12)
- Change From Baseline in Corticosteroid Dose at Month 12(Baseline and Month 12)
- Change From Baseline in the Percentage of Participants That are Steroid-free at Month 12(Baseline and Month 12)
- Number of Participants that initiated Vedolizumab treatment and are still on Vedolizumab treatment at 12 months of follow-up(Baseline up to Month 12)
- Number of Participants with Reporting one or More Adverse Events and Serious Adverse Events (SAEs)(Baseline up to Month 12)
- Number of Participants Based on CD-related Emergency Room (ER) Visits, Hospitalizations, or Surgeries(Baseline up to Month 12)
- Number of Participants With Reasons for Discontinuation of Vedolizumab Treatment(Baseline up to Month 12)
- Number of Participants Based on Subsequent Biologic Therapy Type(Baseline up to Month 12)
- Number of Participants that Received vedolizumab Dose Optimization(Baseline up to Month 12)
- Time to vedolizumab Dose Optimization(Baseline up to Month 12)