NCT04133194招募中4 期
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)
Flemming Bendtsen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Medical Adherence
研究概览
简要总结
Several oral mesalazine (5-ASA) formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer. Recently, a new formula for 5-ASA has been approved by the Danish Medicine Agency, with a single tablet regime per day.
Primary purpose:
• To investigate whether a simplified treatment regimen for 5- ASA (1600 mg as one tablet per day [intervention]) improves adherence with preserved remission rates compared to conventional therapy.
Secondary purposes:
- Compare levels of endoscopic, mucosal and histological inflammation in predicting risk of relapse between the intervention group and the conventional therapy group.
- Investigate whether a simplified treatment regimen improves the disease course compared to the conventional therapy.
- To assess the correlation between different endpoints and the disease courses, with the use of clinical, endoscopic, histological, self-reported and biochemical markers.
- Improve, correlate and assess patient-reported outcomes in a prospective manner.
- To establish a biobank of cases with quiescent/mild ulcerative colitis (UC) for identification of future biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age between and including 18 and 60
- •Diagnosed with UC according to the Copenhagen Diagnostic Criteria
- •Length of disease of max. 10 years
- •Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
- •Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2
- •Have had a relapse within the last 2 years
- •Defined as the need of escalation of treatment or change medical treatment.
排除标准
- •Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
- •On immunomodulators, including methotrexate
- •On any biological therapy
- •Any previous abdominal surgery related to UC
- •Any chronic infections (e.g. HBV, HCV, HIV)
- •Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
- •Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators.
- •Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.
- •Any previous documented allergic reaction to tested the medical drugs
研究组 & 干预措施
1600 mg Asacol (mesalazine)
Experimental
1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year
干预措施: Mesalazine (Drug)
800 mg Asacol (mesalazine)
Active Comparator
800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year
干预措施: Mesalazine (Drug)
结局指标
主要结局
Medical Adherence
时间窗: through study completion, an average of 2 year
Measured byf drug accountability log (outcome 1) and "Medical adherence rating scale" (MARS, outcome 2) separately, excl. pregnant and breastfeeding women. Further detail see outcome 1 and 2
次要结局
- Remission - days(through study completion, an average of 2 year)
- Remission and relapse - episodes(through study completion, an average of 2 year)
- Assessment of disease activity by the Simple clinical colitis activity index (SCCAI)(through study completion, an average of 2 year)
- Assessment of endoscopic severity by the Mayo endoscopic score(through study completion, an average of 2 year)
- Assessment of histological severity by the Geboes score(through study completion, an average of 2 year)
- Changes in disease specific quality of life(through study completion, an average of 2 year)
- Changes in disability among ulcerative colitis patients(through study completion, an average of 2 year)
- Assessment of disease activity by Mayo Score(through study completion, an average of 2 year)
- Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)(through study completion, an average of 2 year)
- Assessment of histological severity by the Nancy Index(through study completion, an average of 2 year)
- Assessment of histological severity by the Robarts Histopathology Index (RHI)(through study completion, an average of 2 year)
- Correlation between the different clinical scores(through study completion, an average of 2 year)
- Relapse - days(through study completion, an average of 2 year)
- Changes in resilience(through study completion, an average of 2 year)
- Changes in quality of life(through study completion, an average of 2 year)
- Changes in sleep quality(through study completion, an average of 2 year)
研究者
Flemming Bendtsen
Professor, Senior doctor, MDSci
Copenhagen University Hospital, Hvidovre
研究点 (1)
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