Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Number of patients with clinical relapse
研究概览
简要总结
To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.
详细描述
Patients using adalimumab for Crohn's disease or ulcerative colitis who are in clinical remission will be followed with fecal calprotectin monitoring every 3 months. Patients with a sustained rise in calprotectin who maintain clinical remission will be offered an opportunity to have an increase in adalimumab for three months. Patients who use the three months of increased adalimumab dosing will be compared to patients who do not use increased dosing to determine if relapse rates differ between these two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18 and older with Crohn's disease and ulcerative colitis
- •Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)
- •Patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly).
排除标准
- •Pregnant women or plans for pregnancy within 3 months of study inclusion
- •Abdominal abscess
- •Inability or unwillingness to provide informed consent
- •Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
研究组 & 干预措施
Temporary increase in adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Number of patients with clinical relapse
时间窗: One year
Clinical relapse will be based on increased clinical symptoms or endoscopic changes requiring use of corticosteroids, addition of an immunomodulator, change to another biologic therapy, or surgery.
次要结局
未报告次要终点