The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- change in pseudo F-statistic
研究概览
简要总结
Primary objective: To determine the changes in circadian activity rhythms and disease activity in rheumatoid arthritis (RA) patients from pre-treatment to one month after Enbrel initiation.
Secondary objectives:
- To determine if there is an association between changes in circadian rhythm and changes in disease activity in active RA after initiation of Enbrel
- To determine if the changes in circadian activity rhythms are associated with systemic inflammation in RA patients
- To determine changes in traditional sleep quality variables from pre-treatment to one month after Enbrel initiation in RA patients
详细描述
Rheumatoid arthritis (RA) is a chronic and debilitating disease. However, the symptoms of RA show variation over the course of the day, with worsening symptoms in the morning. This worsening of symptoms in the morning is correlated with an increase in inflammation in the body.
Biologic therapies, such as Enbrel (etanercept), appear to improve energy, pain and quality of life in patients with RA, and these changes may occur before a doctor is able to detect changes during the patient's physical examination. It is possible that a patient's response to biological agents can be rapidly determined by assessing circadian activity (also called "rest-activity circadian rhythms" or RAR).
Currently, wrist actigraphy bands, which are worn for a period of time, can reliably provide information about RAR. Wrist actigraphy bands are small electronic devices worn on the wrist (similar to a watch) that records the subject's level of activity throughout the day. Studies in osteoarthritis and in rheumatoid arthritis have found subjects with joint pain to have significant differences in RAR, and disrupted RAR has been associated with disease activity.
This study will provide information about 24-hour circadian activity rhythms before and after 3-4 weeks of Enbrel treatment in study subjects with active rheumatoid arthritis. The study will assess patients who are starting on Enbrel that has been prescribed by their doctor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •6/28 tender and 6/28 swollen joints (e.g. active rheumatoid arthritis)
- •CRP ≥ 1.5mg/L
- •Insufficient response or intolerance to ≥1 disease modifying anti-rheumatic drug (DMARD) which must include methotrexate or hydroxychloroquine, or sulfasalazine or leflunomide and at stable dose for 4 weeks
- •If taking Glucocorticoids, stable dose from 0-10mg a day for 2 weeks, and remain stable for the 4 week study
- •Appropriate to start on a biologic agent for RA, as determined by patient's physician.
排除标准
- •Prior use of a biologic agent for 4 weeks prior to the study
- •Evidence of positive tuberculosis (TB) test, purified protein derivative (PPD) or Quantiferon or prophylactic treatment instituted 4 weeks before study, or hepatitis B core antibody
- •No medical condition that would prevent completion of the study
结局指标
主要结局
change in pseudo F-statistic
时间窗: 7 days before, 7 days after and 28-35 days after Enbrel treatment
indicator of overall robustness of circadian rhythm
change in acrophase
时间窗: 7 days before, 7 days after and 28-35 days after Enbrel treatment
time of daily peak circadian activity
change in mesor
时间窗: 7 days before, 7 days after and 28-35 days after Enbrel treatment
mean circadian rhythm
change in amplitude
时间窗: 7 days before, 7 days after and 28-35 days after Enbrel treatment
indicator of strength of circadian rhythm
change in Disease Activity Score (DAS)
时间窗: 7 days before, 7 days after and 28-35 days after Enbrel treatment
RA disease severity
次要结局
- change in general health visual analogue scale (VAS)(7 days before, 7 days after and 28-35 days after Enbrel treatment)
- change in C-reactive protein (CRP)(7 days before, 7 days after and 28-35 days after Enbrel treatment)
- change in rheumatoid factor (RF)(7 days before, 7 days after and 28-35 days after Enbrel treatment)
- change in sleep efficiency as assessed by wrist actigraphy(7 days before, 7 days after and 28-35 days after Enbrel treatment)
- change in sleep duration as assessed by wrist actigraphy(7 days before, 7 days after and 28-35 days after Enbrel treatment)