2024-517502-28-01招募中4 期
Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- cost-effectiveness of therapeutic drug monitoring based drug de-escalation
研究概览
简要总结
To evaluate whether subcutaneous vedolizumab therapeutic drug monitoring (TDM)-guided de-escalation will be cost-effective, compared to normal dosing regimen in patients with inflammatory bowel disease in remission.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •crohn's disease or ulcerative colitis in remission
排除标准
- •presence of anti-drug antibodies against vedolizumab
- •Patients with short bowel syndrome, an ostomy or a symptomatic stricture
结局指标
主要结局
cost-effectiveness of therapeutic drug monitoring based drug de-escalation
cost-effectiveness of therapeutic drug monitoring based drug de-escalation
次要结局
未报告次要终点
研究者
S.I. Anjie
Scientific
Amsterdam UMC Stichting
研究点 (1)
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