NCT02994836已完成4 期
Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2017年4月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
研究概览
简要总结
This study will be a multicentre prospective randomized trial to assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses
详细描述
A multicentre prospective randomized trial.
Hypothesis:
The discontinuation of anti-TNF treatment in inflammatory bowel disease (IBD) patients in clinical remission is associated with an increased risk of recurrence compared with maintaining such treatment.
Main objective:
To assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 diagnosed with IBD by the usual criteria; both Crohn's and ulcerative colitis disease.
- •Patients older than 18 years.
- •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 clinical remission period with the drug at non-intensified dose it must have been at least 6 months.
- •The administration of ≥10 mg/kg/8 weeks or 5 mg / kg / ≤ 4 weeks, in the case of infliximab, and 40 mg / week, in the case of adalimumab, is considered an intensified dose.
- •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 3 months prior to the screening visit) 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.(made up to 3 months prior to the screening visit)
排除标准
- •Age less than 18 years.
- •Patients who have been treated with anti-TNF for other indication than the IBD.
- •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 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.
结局指标
主要结局
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
时间窗: Change at 12 months.
次要结局
- Radiologic activity assessment(12 Months. Month 0, month 12 or relapse)
- Quality of life assessment(Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12)
- The Work productivity and activity assessment(Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12)
- Clinical activity assessment(Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12)
- Endoscopic activity assessment(12 Months. On the Month 0, month 12 or relapse)
研究者
研究点 (2)
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