NCT05056441已完成不适用
ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study
Takeda31 个研究点 分布在 3 个国家目标入组 623 人开始时间: 2021年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 623
- 试验地点
- 31
- 主要终点
- Cumulative Rates of Clinical Remission Over 36 Months Compared Between VDZ and UST Cohorts
研究概览
简要总结
The main aim of this study is to compare long-term remission in participants receiving vedolizumab (VDZ) and those receiving ustekinumab (UST).
In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.
详细描述
This is a non-interventional, retrospective study of participants with CD. The study will review the medical charts of participants who have initiated the treatment with vedolizumab and ustekinumab or another biologic agent (post- index).
The study will aim to enroll approximately 700 participants, with 350 participants in each of the following cohorts:
- Cohort 1: Vedolizumab
- Cohort 2: Ustekinumab
The data for participants will be collected in two main periods:
- Pre-Index Event Period: From the date of diagnosis of CD until the date of index when vedolizumab or ustekinumab was initiated during the eligibility period.
- Post-Index Event Period: From one day post-index when vedolizumab or ustekinumab was initiated during the eligibility period until chart abstraction initiation, unless the date of death or loss to follow-up is before the date of chart abstraction initiation.
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
- •Has a diagnosis of CD documented in the medical records.
- •Has received at least one dose of vedolizumab or ustekinumab at one of the participating study sites during the eligibility period.
- •Was biologic-naïve (no prior biologic use for any pathology, including CD) at the time of index event.
- •Has completed induction phase and has a minimum of a six-month duration between the date of the index event and the date of chart abstraction initiation and was still under active care at the site six months post-index date.
排除标准
- •Has received vedolizumab or ustekinumab as part of a clinical trial in their lifetime (includes index event).
- •Has initiated index treatment as combination therapy with two biologic agents.
- •Has received previous treatment with biologic agents for CD or conditions other than CD ever in their lifetime.
- •Has medical chart empty or missing.
- •Part or all of the participant's index treatment was received at a different site, and the participant's medical chart pertaining to this care is not accessible.
- •Has received a subcutaneous formulation of ustekinumab for induction (that is, a subcutaneous induction dose of ustekinumab prior to ustekinumab's approval for CD in the study countries).
结局指标
主要结局
Cumulative Rates of Clinical Remission Over 36 Months Compared Between VDZ and UST Cohorts
时间窗: Baseline up to 36 months post-index date
Clinical remission will be defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150 points, or if unknown, Harvey-Bradshaw Index (HBI) Overall score less than or equal to (\<=) 4 points, or if unknown, Modified HBI (mHBI) score \<=4 points, or if unknown, changes in biomarker assessments (C-reactive Protein, Fecal Calprotectin, and albumin) or remission status recorded in medical chart as 'in remission'. CDAI score \<150 indicates quiescent disease and \>450 indicates extremely severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. mHBI consisted of 4 clinical parameters- general well-being, abdominal pain, number of liquid stools per day and additional manifestation. HBI and mHBI total score will be sum of individual parameters, score ranges 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores is more severe disease.
次要结局
- Cumulative Rates of Mucosal Healing Over 36 Months Compared Between VDZ and UST Cohorts(Baseline up to 36 months post-index date)
- Cumulative Rates of CS-free Response Over 36 Months Compared Between VDZ and UST Cohorts(Baseline up to 36 months post-index date)
- Time to Treatment Discontinuation Compared Between VDZ and UST Cohorts(From index event up to a maximum of 36 months post-index date)
- Cumulative Rates of Clinical Response Over 36 Months Compared Between VDZ and UST Cohorts(Baseline up to 36 months post-index date)
- Time to Treatment Switching of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Incidence Rate of SAEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of Clinical Remission Over 30 Months Compared Between VDZ and UST Cohorts(Baseline up to 30 months post-index date)
- Cumulative Rates of Corticosteroid (CS)-free Remission Over 36 Months Compared Between VDZ and UST Cohorts(Baseline up to 36 months post-index date)
- Incidence Rate of Adverse Events (AEs) Compared Between VDZ and UST Cohorts(From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 6 post-index date))
- Incidence Rate of CD-related Hospitalizations Compared Between VDZ and UST Cohorts(From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 12 post-index date))
- Time to Treatment Discontinuation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of Clinical Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of Corticosteroid (CS)-free Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of Deep Remission Over 36 Months Compared Between VDZ and UST Cohorts(Baseline up to 36 months post-index date)
- Time to Treatment Switching Compared Between VDZ and UST Cohorts(From index event up to a maximum of 36 months post-index date)
- Time to Dose Escalation Compared Between VDZ and UST Cohorts(From index event up to a maximum of 36 months post-index date)
- Incidence Rate of Serious Infections (SIs) Compared Between VDZ and UST Cohorts(From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 6 post-index date))
- Time to Dose Escalation of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Incidence Rate of Serious Adverse Events (SAEs) Compared Between VDZ and UST Cohorts(From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 6 post-index date))
- Incidence Rate of Emergency Department (ED) Visits Compared Between VDZ and UST Cohorts(From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 12 post-index date))
- Incidence Rate of Disease Exacerbations Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of Clinical Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of CS-free Response of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Incidence Rate of CD-related Surgical Procedures compared between VDZ and UST cohorts(From the index event (Baseline) to the earliest date of chart abstraction initiation, death or last contact with the site (up to approximately Month 12 post-index date))
- Incidence Rate of SIs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of Mucosal Healing of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Cumulative Rates of Deep Remission of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
- Incidence Rate of AEs of Subsequent Line Treatments Compared Between VDZ and UST Cohorts(From the date of initiation of subsequent line treatment up to the earliest date of chart abstraction initiation, death or last contact with the site (up to a maximum of 36 months post-index date))
研究者
研究点 (31)
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