Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 10
- 主要终点
- percentage of patients who respond to the treatment
研究概览
简要总结
The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
详细描述
he role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
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
- Single (Investigator)
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
- •UC known and diagnosed by established clinical-endoscopic and histological criteria or newly-diagnosed UC, based on clinical and endoscopic findings, and about to start treatment with corticosteroids.
- •current hospitalization with severe Ulcerative Colitis exacerbation as defined by a Lichtiger score of >10
- •if taking thiopurines, the dose must be stable for 2 months prior to admission
排除标准
- •pregnant women
- •allergy/unable to take study medications
- •active infection
- •severe renal/liver/cardiorespiratory condition
- •toxic megacolon or signs of imminent colectomy
- •treatment with an anti-tumor necrosis factor in 3 months prior to admission
- •prior treatment with cyclosporin or tacrolimus
- •alcohol dependancy
- •unwilling/ unable to give an informed consent
- •participation in clinical trials in the last 2 months prior to admission
研究组 & 干预措施
5-ASA naive arm 2
IV corticosteroids only / PO Methylprednisolone
干预措施: corticosteroids only (Drug)
present 5-ASA arm 1
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
干预措施: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone (Drug)
5-ASA naive arm 1
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
干预措施: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone (Drug)
present 5-ASA arm 2
IV corticosteroids only / PO Methylprednisolone
干预措施: corticosteroids only (Drug)
结局指标
主要结局
percentage of patients who respond to the treatment
时间窗: day 7
次要结局
- the percentage of patients in need of a rescue medication(day 5, 7)
- colectomy rate(1 month, 3 months post randomization)
研究者
Dr. Ofir Harnoy MD
MD
Sheba Medical Center