EUCTR2006-006632-22-BE进行中（未招募）1 期
Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial
niversity of Leuven, Division of Gastroenterology0 个研究点目标入组 100 人开始时间: 2006年12月19日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Men and women of 18 years and older willing and able to give written informed consent.
- •2.Patients in clinical remission and/or complete response (as judged by the investigator) (CDAI<200) on infliximab treatment (5mg/kg q8 weeks) for at least 6 months.
- •3.Patients with a documented clinical response to infliximab of 8 weeks duration. Patients with a draining perianal fistula at the time of diagnosis, who receive infliximab for luminal disease are eligible.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients receiving infliximab doses exceeding 5 mg/kg
- •2.Incomplete response to infliximab (CDAI>200)
- •3.Pregnant or lactating women. Men and women of childbearing potential should use a effective double barrier method for contraception.
- •4.Patients with intercurrent medical conditions or laboratory abnormalities that preclude further administration of anti-TNF agents such as demyelinating diseases or severe heart failure.
- •5.Patients with an imminent need for surgery such as those with a symptomatic fibrotic stricture.
- •6.Patients with a draining abdominal enterocutaneous fistula.
研究者
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