Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adalimumab trough level
研究概览
简要总结
RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.
详细描述
IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 > 18y
- •Intensified adalimumab regime at least 4 weeks prior to enrollment.
- •Immunosuppressants are allowed if a stable dose for > 12w is maintained.
- •Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained.
排除标准
- •Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
- •Pregnant or lactating women.
研究组 & 干预措施
40mg1w
Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks
干预措施: Adalimumab (Drug)
80mg2w
Adalimumab at an administration of 80 mg every two weeks
干预措施: Adalimumab (Drug)
结局指标
主要结局
Adalimumab trough level
时间窗: 12 weeks
Drug levels will be measured during 12 weeks of treatment
次要结局
- Clinical response for Ulcerative Colitis(12 weeks)
- Clinical response for Ulcerative colitis(12 weeks)
- Clinical response for Crohn´s Disease(12 weeks)
- Fecal calprotectin(12 weeks)
- Blood acute phase reactants(12 weeks)
- Antibodies to Adalimumab (ADA)(12 weeks)
- Treatment Satisfaction(12 weeks)
- QOL(12 weeks)
研究者
María Dolores Martín Arranz, PhD
Director
Hospital Universitario La Paz