NCT03689673已完成不适用
A Prospective, Multicenter, Non-interventional Study to Describe the Effectiveness of Etiasa® (Sustained Release Granules of Mesalazine or 5-Aminosalicylate, or 5-ASA) in Maintenance Treatment of Ulcerative Colitis (UC )
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 607
- 试验地点
- 26
- 主要终点
- Median time to relapse according to the patients with different maintenance Etiasa® daily dose
研究概览
简要总结
The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female patient ≥ 18 years old and ≤ 65 years old
- •Patient has provided written informed consent to participate in the study after the purpose and nature have been clearly explained to him/her;
- •Patient with documented diagnosis of mild-moderate Ulcerative Colitis (UC). The "documented diagnosis" should include a typical histology observed at least once in the course of the disease;
- •Have a documented history of UC that has been successfully maintained in complete steroid-free remission for at least 1 month prior to study entry;
- •The modified mayo score ≤ 2, without subscore >1, which is supported by a rectum-sigmoidoscopy or a colonoscopy;
- •Regimen of maintenance of remission contains Etiasa®
- •Patient mentally and physically able to answer the questionnaire.
排除标准
- •Have a history of allergy or hypersensitivity to salicylates, 5-aminosalicylates, or any component of Etiasa®;
- •Pregnant and breastfeeding women, approaching childbirth female or unwilling to take birth control measures during the study;
- •A topical 5-aminosalicylate agent is included in the regimen;
- •Patients with infectious colitis (positive for germs, ovum or parasites causing bowel disease);
- •Treated with the other study drug at enrollment, or within past 3 months of enrollment;
- •Serious underlying disease other than UC which in the opinion of the investigator may interfere with the patient's ability to participate fully in the study;
- •Crohn's disease;
- •Pancreatitis;
- •Known bleeding disorders;
- •Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
结局指标
主要结局
Median time to relapse according to the patients with different maintenance Etiasa® daily dose
时间窗: Until relapse or maximum 5 years
次要结局
- Hemoglobin change from baseline to each hospital visit and relapse(From baseline up to 5 years)
- Calprotectin change from baseline to each hospital visit and relapse(From baseline up to 5 years)
- C-reactive protein (CRP) change from baseline to each hospital visit and relapse(From baseline up to 5 years)
- Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose(5 years or at study termination)
- Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse(From baseline up to 5 years)
- Colorectal cancer (CRC) incidence rate(Until relapse or maximum 5 years)
- Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse(From baseline up to 5 years)
- Quality of Life (QoL) changes during the treatment(From baseline until relapse or 5 years or early termination)
研究者
研究点 (26)
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