Pragmatic Randomized Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 42
- 主要终点
- Percentage of Participants with Mayo Endoscopic Sub-score = 0
研究概览
简要总结
The purpose of this study is to provide evidence that a therapy of Ulcerative Colitis (UC) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprotectin (FC) (substance that is released when intestines are inflamed and that can be measured in faeces), can provide significantly higher benefit for the participants in terms of disease control and quality of life (QoL) improvement, compared to a symptom-based approach only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Adult Participants (≥ 18 years old)
- •Participants with active mild-to-moderate UC (with RB and bowel inflammation confirmed by endoscopy)
- •Participants with treatment with 5-aminosalicylic acid (5-ASA) ≤ 2.4 g/day or with no treatment regimen at Baseline
- •Participants who agree to use FC home test (to dose FC in faeces as a marker of inflammation)
- •Participants with internet access and smartphone with camera
排除标准
- •Participants currently enrolled in another interventional study
- •Participants not willing to undergo an endoscopy at the end of study
- •Participants with contraindications to treatment with 5-ASA and/or 2nd generation corticosteroids
- •Participants not willing to perform FC self-testing in faeces at home
研究组 & 干预措施
Intervention arm
Treatment optimization (escalation/de-escalation) performed by the investigator based on participant self-monitoring of FC values and/or clinical symptoms (patient-reported outcome-2 [PRO-2] scoring).
The FC Test and/or PRO-2 scoring will be done by the participant at home every month during active disease, every 3 months in remission, or when a participant feels the need/presents clinical symptoms.
干预措施: Faecal Calprotectin Home Test (Other)
Intervention arm
Treatment optimization (escalation/de-escalation) performed by the investigator based on participant self-monitoring of FC values and/or clinical symptoms (patient-reported outcome-2 [PRO-2] scoring).
The FC Test and/or PRO-2 scoring will be done by the participant at home every month during active disease, every 3 months in remission, or when a participant feels the need/presents clinical symptoms.
干预措施: PRO-2 Scoring (Other)
Reference arm
Treatment optimization (escalation/de-escalation) performed by the investigator based on clinical symptoms (PRO-2 scoring) only.
The PRO-2 scoring will be assessed during clinic visits every 3-months during active disease, every 6 months during remission, or when a participant feels the need; as per recommended standard practice.
干预措施: PRO-2 Scoring (Other)
结局指标
主要结局
Percentage of Participants with Mayo Endoscopic Sub-score = 0
时间窗: At 12 months
Defined as the percentage of participants achieved mucosal healing (Mayo endoscopic sub-score of 0 \[normal friability\]). The Mayo endoscopic scoring ranges from 0-3 with higher scores indicating greater disease severity. The score is defined as 0-3: 0= Normal; 1=Mild friability; 2 = Moderate friability; 3 = Exudation, spontaneous hemorrhage.
次要结局
- Percentage of Participants with Stool Frequency <=1(At 12 months)
- Change in Work Productivity and Activity Impairment: Ulcerative Colitis (WPAI: UC) Questionnaire(From Baseline over 12 Months)
- Faecal Calprotectin Value Changes at the Defined Study Time Points (Interventional Arm Only)(Over 12 months)
- Percentage of Participants with Mayo Endoscopic Sub-score <=1(At 12 months)
- Percentage of Participants Escalated to Rescue Therapy(Over 12 months)
- Number of Ulcerative Colitis Related Procedures and/or Surgeries(Over 12 months)
- Percentage of Participants with Rectal Bleeding = 0(At 12 months)
- Change in Short Form Questionnaire-36 (SF-36)(From Baseline over 12 Months)
- Number of Outpatients Visits and Calls (Outside of Study Schedule)(Over 12 months)
- Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(From Baseline over 12 Months)
- Number of Hospitalization Days(Over 12 months)