Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,006
- 试验地点
- 1
- 主要终点
- Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies
研究概览
简要总结
The primary reason of this study is to observe current and past treatment in adult participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Brazil. There is no treatment involved in this study, this is only an observational review of past and ongoing treatment data relating to Vedolizumab treatment for IBD (including Ulcerative Colitis [UC] and Crohn's Disease [CD]).
详细描述
This is a non-interventional, observational study in participants with IBD participating in the PSP. This study will enroll approximately 2160 participants. The study is divided into two cohorts according to data collection:
- Retrospective Cohort
- Prospective Cohort
The retrospective cohort is for participants that were included in the PSP prior to study start. This retrospective cohort will have data of participants that are actively participating in the Program and only their retrospective data will be collected. The prospective cohort is for participants that are starting their participation in the PSP using their data from the consent date until the end of the study or until the discontinuation in the PSP or in the study.
Retrospective and prospective cohorts will be collected from the PSP database, which will be the only source of participants for this study.
This single country trial will be conducted in Brazil. The duration of this observational study will be approximately 26 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Who participated or who will participate in the "Entre Nós" program and participant who consent to participate in the study.
排除标准
- •No exclusion of participants is expected in the present study and the quality of the data relies in participant reported outcomes for the "Entre Nós" program.
研究组 & 干预措施
Prospective Cohort
Participants diagnosed with UC or CD with prescription of vedolizumab, and have participation in PSP after the study start will be observed prospectively in this study.
干预措施: No Intervention (Other)
Retrospective Cohort
Participants diagnosed with UC or CD with prescription of vedolizumab, and were included in the PSP program (which has started in 2016) before the study starts will be observed retrospectively in this study.
干预措施: No Intervention (Other)
结局指标
主要结局
Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies
时间窗: Up to approximately 9 years
Treatment persistence will be defined as participants who did not discontinue treatment during follow-up. Advance therapies include biologics and tofacitinib.
次要结局
- Number of Participants With Therapies Used Before Vedolizumab Treatment(Up to approximately 9 years)
- Number of Participants With Vedolizumab Treatment Scheme (Dose Escalation and De-escalation) for Conventional and Advanced Therapies(Up to approximately 9 years)
- Number of Participants Based on Quality-of-life (QOL) as Assessed by Short Inflammatory Bowel Disease Questionnaire 10 (SIBDQ-10) in Prospective Cohort(At the index date (vedolizumab initiation), and at 14 and 52 weeks from index date)
- Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD(Up to approximately 9 years)
- Number of Participants With Comorbidities Associated or not With CD or UC(Up to approximately 9 years)
- Duration of Disease(Up to approximately 9 years)
- Percentage of Participants Diagnosed With UC or CD(Up to approximately 9 years)
- Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)(Up to approximately 9 years)
- Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF(Up to approximately 9 years)