Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- 12 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
研究概览
简要总结
Current standard of care of rheumatoid arthritis (RA) management includes a routine clinical assessment of disease activity to adjust therapy. For the most part, therapy adjustment for therapy non-response and/or suboptimal therapy response leads to therapy switch within the same class of therapy or to a different class of therapy. The lack of objective data to titrate dose of a given therapeutic agent for maximal possible efficacy makes it difficult for providers and payors to titrate dose as needed.
Therapeutic drug monitoring (TDM) provides objective data for a proactive and individualized therapy optimization based on serum drug levels and the presence or absence of anti-drug antibodies. Maintaining optimal trough drug concentration is a proven concept of therapeutics. With respect to adalimumab, this approach helps to maximize therapeutic efficacy and prevent anti-adalimumab antibody development. However, lack of drug and disease state specific published data creates a barrier for a wider adoption of TDM into clinical practice.
The objective of this single site, open label, randomized, parallel group pilot study is to investigate whether proactive therapeutic drug monitoring based adalimumab dose optimization results in higher rate of achieving and/or maintaining therapeutic goal compared to standard of care in patients with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Diagnosis of rheumatoid arthritis
- •Starting or already being treated with standard dose adalimumab, 40 mg subcutaneously (SQ) every two weeks
- •Good medication adherence rate defined as Proportion of Days Covered (PDC) 80% and above
排除标准
- •Detectable anti-adalimumab antibodies
- •Overlapping immune mediated diseases
- •Steroid therapy for more than 2 months prior to study enrollment
- •Poor medication adherence rate (PDC < 80%)
- •History of recurrent infection resulting in therapy pause
- •Pregnant or lactating
结局指标
主要结局
12 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
时间窗: baseline, 12 months
Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.
9 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
时间窗: baseline, 9 months
Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.
3 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
时间窗: baseline, 3 months
Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.
6 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
时间窗: baseline, 6 months
Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.
次要结局
- Percent of participants who achieved low or near remission disease severity(baseline, 3 months, 6 months, 12 months)