NCT00546546已完成4 期
Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives26 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 26
- 主要终点
- number of 3-months periods with remission
研究概览
简要总结
Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 yr old
- •diagnosis of Crohn's disease
- •intestinal lesions demonstrated during the last 6 months
- •disease duration < 6 months
- •patients at high risk of disabling disease (having 2 criteria out of the 3 following: age < 40, perinanal disease, steroid for the first flare)
排除标准
- •prior prescription of immunosuppressants
- •severe course requiring early immunosuppressants (steroid resistance, xtensive disease, disabling perianal disease)
- •intestinal resection
- •active infectious disease including HIV
- •hepatic failure
- •renal failure
- •pregnancy
- •high probability of poor compliance
研究组 & 干预措施
Immunossuppresive treatment
Experimental
Switch to different immunosuppresive treatment in case of relapse.
干预措施: early immunosuppressants (azathioprine, methotrexate) (Drug)
结局指标
主要结局
number of 3-months periods with remission
时间窗: 3 yrs
次要结局
- quality of life questionnaire(3 yrs)
- 3-yr cumulative steroid dose(3 years)
研究者
研究点 (26)
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