Circadian RA Study in Rheumatoid Arthritis Subjects
The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm
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
研究概览
详细说明
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.
研究类型
联系人和位置
学习地点
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California
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Sacramento、California、美国、95817
- UC Davis Center for Musculoskeletal Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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change in pseudo F-statistic
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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indicator of overall robustness of circadian rhythm
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in acrophase
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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time of daily peak circadian activity
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in mesor
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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mean circadian rhythm
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in amplitude
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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indicator of strength of circadian rhythm
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in Disease Activity Score (DAS)
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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RA disease severity
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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change in sleep efficiency as assessed by wrist actigraphy
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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an index of sleep fragmentation, percentage (%) of time spend sleeping after "lights off"
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in general health visual analogue scale (VAS)
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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subject's general health
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in C-reactive protein (CRP)
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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systemic inflammation
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in rheumatoid factor (RF)
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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measures amount of rheumatoid factor present in the blood
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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change in sleep duration as assessed by wrist actigraphy
大体时间：7 days before, 7 days after and 28-35 days after Enbrel treatment
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how long (minutes) the subject sleeps 24 hour period
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7 days before, 7 days after and 28-35 days after Enbrel treatment
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合作者和调查者
调查人员
- 首席研究员：Nancy E Lane, M.D.、UC Davis Center for Musculoskeletal Health
- 首席研究员：Katie Stone, Ph.D.、California Pacific Medical Center Research Institute
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Etanercept的临床试验
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Baylor College of MedicineCenter for Cell and Gene Therapy, Baylor College of Medicine招聘中
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mAbxience Research S.L.完全的