Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 7
- 主要终点
- To characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis
研究概览
简要总结
Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α) approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs (DMARDs) and for the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.
However, almost one third of patients have no response and approximately 15% develop antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a relationship between adalimumab concentration and clinical response obtained after 6 month of treatment. Furthermore adalimumab concentration measured 3 months after initiation seems to predict the clinical response at 6 months.
There is an important inter individual pharmacokinetic variability of adalimumab. Side effects may occur at the recommended dose and more than 3 months of treatment are generally required to estimate the clinical response.
A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the response and to avoid dose related side effects. To date there is no definite adalimumab target concentration predictive of the clinical response to allow such a pharmacologic monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •RA according to the American College of Rheumatology (ACR) 1987 criteria
- •Treatment with Adalimumab has been chosen by the physician / patient
- •Treatment given in accordance to the SPC
- •Stable Disease modifying anti rheumatic drugs (DMARDs) and glucocorticoids 4 weeks before enrollment and during the study period.
- •Signed consent
排除标准
- •more than one previous treatment with anti TNF-alpha
- •Past history of malignancy, AIDS
- •Pregnancy
- •Change in DMARDS or glucocorticoid dose 4 weeks before entering the study
- •Active or latent tuberculosis, other active infections
- •Surgery scheduled during the study period
研究组 & 干预措施
adalimumab
40 mg every two weeks, by subcutaneous way
干预措施: adalimumab (Biological)
结局指标
主要结局
To characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis
时间窗: During the 26 weeks of follow up.
The primary objective is to characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis (RA). To this aim, adalimumab concentration on the one hand and clinical and biological markers of disease activity on the other hand will be measured at baseline, week 4, week 8, week 12 and at week 26. Pharmacodynamic (PD) parameters will be estimated using PK(pharmacokinetic)-PD models in which Emax (maximum effect) and EC50 (concentration at which the effect is 50% of the maximum) will describe adalimumab effect on each markers of response.
次要结局
- To study the relationship between genetic factors, immunogenicity and response to adalimumab in rheumatoid arthritis(During the 26 weeks of follow up.)