EUCTR2015-001410-10-ES进行中（未招募）1 期
Anti-TNF discontinuation in patients with inflammatory bowel disease: Multicentre, prospective, randomized clinical trial and economic evaluation - EXIT
Fundación de Investigación Biomédica Hospital Universitario de la Princesa0 个研究点目标入组 300 人开始时间: 2016年5月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •?Patients diagnosed with IBD (Crohn's disease or ulcerative colitis)
- •? Patients diagnosed with IBD by the usual criteria; both Crohn's and ulcerative colitis disease.
- •? Patients older than 18 years.
- •? Have received treatment with an anti-TNF drug to induce clinical remission of IBD by clinical practice.
- •? Being the first anti-TNF drug received and the first course of the drug.
- •? In the case of patients with Crohn's disease the indication treatment with anti-TNF it must have been for luminal involvement (no perianal).
- •? Are currently in clinical remission.
- •? The pretreatment period with anti-TNF must have been at least 1 year (and with stable doses during the last year).
- •? The clinical remission period it must have been at least 6 months.
- •? At the time of inclusion, the patient should be receiving concomitant immunosuppressants (thiopurine or methotrexate) to anti-TNF treatment, and must have received these immunosuppressive drugs at stable doses for at least the last 3 months.
- •? In patients with Crohn's disease or ulcerative colitis disease, at baseline colonoscopy (made up to 30 days before inclusion) should not be significant injuries.
- •? In the case of patients with Crohn's ileal or ileocolic disease, in magnetic resonance whole should not be significant injuries.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •? Age less than 18 years.
- •? Patients who have been treated with anti-TNF for other indication than the IBD.
- •? Patients who, at some point, have received an anti-TNF drug dose higher than the standard, intensified; that is, more than 5 mg / kg / 8 weeks, in the case of infliximab, or 40 mg / 2 weeks, in the case of adalimumab.
- •? Patients with Crohn's disease in which the indication for treatment with anti-TNF has been the perianal involvement (or luminal and perianal both); or showing active perianal disease at the time of inclusion.
- •? Patients who have previously discontinued treatment with anti-TNF and subsequently been restarted.
- •? Patients who have previously received it another anti-TNF drug.
- •? Patients with IBD who began treatment with anti-TNF being in clinical remission.
- •? Patients who are not receiving concomitant treatment with immunosuppressants (thiopurine or methotrexate) at the moment (and in the previous 3 months).
- •? Patients undergoing bowel resection surgery; therefore, patients who began anti-TNF therapy to prevent or treat postoperative recurrence in Crohn's disease will be excluded.
- •? Presence of significant endoscopic or radiological lesions
- •? Advanced chronic illness or any other condition that prevents the patient from coming to the clinic for monitoring or follow-up.
- •? Patients who are pregnant, breastfeeding or intending to become pregnant during the course of the study.
- •? Refusal to give consent for participation in the study.
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