NCT00304252终止2 期
A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 192
- 试验地点
- 5
- 主要终点
- The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.
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
- Double
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
- •Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study
排除标准
- •Any other treatment for the maintenance of remission of Crohn's disease
结局指标
主要结局
The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26.
次要结局
- The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures:
- The proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 52
- Time to relapse
- Change from baseline to end of treatment in Quality of Life (IBDQ) score, CDAI score, biological markers of inflammation (CRP and ESR), number of fistulas (including new fistulas and closure of existing ones), and antibodies to interferon beta-1a.
研究者
研究点 (5)
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