Comparative Effectiveness of Biologics or Small Molecule Therapies After Failure of Anti-TNF Treatment in Patients With Crohn's Disease and Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- PROMIS Measures of Pain Interference
研究概览
简要总结
The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.
详细描述
This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.
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
- •age greater than or equal to 18;
- •diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);
- •initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.
排除标准
- •less than 18 years of age
结局指标
主要结局
PROMIS Measures of Pain Interference
时间窗: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health).
PROMIS Measures of Fatigue
时间窗: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue (poorer health).
次要结局
- Number of Participants Using Corticosteroids at Follow-Up(4-10 months after medication initiation)
- Mayo Clinic Score(Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window))
- Number of Participants With Index Medication Persistence(4-10 months after medication initiation)
- Short Crohn's Disease Activity Index (sCDAI)(Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window))
- PROMIS Social Satisfaction Score(Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window))