REal-world Study of the Clinical Profile and Treatment Outcomes of Advanced Therapies for Ulcerative Colitis in Portugal-READ UC
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission
研究概览
简要总结
This study aims to characterize the Portuguese population of patients with moderate-to-severe UC receiving advanced therapies, by describing clinical and sociodemographic characteristics, and remission outcomes . The clinical, biochemical, endoscopic, and histological outcomes will also be described, as well as frequency of selected EIM, comorbidities and the uptake of preventive care measures and hospitalizations .
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Aged at least 18 years old
- •Diagnosed with Ulcerative Colitis, confirmed by a gastroenterologist
- •Treated with anti-TNF or anti-integrin or JAK inhibitors drugs for at least 16 weeks
- •Followed at one of the participating centers when initiating and during the current treatment
- •Signed informed consent
排除标准
- •Treated with anti-TNF or anti-integrin or JAK inhibitors drugs at induction phase
- •Enrolled in randomized clinical trials or other experimental studies in the last 12 months prior to initiation of advanced therapy
结局指标
主要结局
Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission
时间窗: at baseline
- percentage of participants with both a Mayo stool frequency subscore of 0 or 1 and Mayo rectal bleeding subscore of 0 , and a Faecal Calprotectin concentrations \< to the cut-off concentration of 150-200 μg/g
Demographics and clinical characteristics of Ulcerative Colitis participants
时间窗: till baseline
* percentage of gender distribution, age distribution, smoking status distribution, height and weight distribution, BMI distribution * percentage of Ulcerative Colitis extend and severity (Montreal criteria) distribution, percentage of prior acute severe Ulcerative Colitis, percentage of clinical relapses
次要结局
- Proportion of participants with steroid use(at baseline)
- Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations(till baseline)
- Proportion of Ulcerative Colitis participants with symptomatic remission(at baseline)
- Total time without steroids since initiation of current advanced therapy(since initiation current advanced therapy till baseline)
- Frequency of registered preventive care measures(in the 12 months prior initiation current advanced therapy till baseline)
- Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities(till baseline)
- Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration(at baseline)
- Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g(at baseline)
- Frequency and incidence of hospitalizations and emergency visits(since initiation current adavnced therapy till baseline)
- Duration of symptomatic remission(since initiation symptomatic remission till baseline)
- Proportion of participants in steroid-free remission(at baseline)
- Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay(since initiation current advanced therapy till baseline)