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
調査の概要
詳細な説明
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.
研究の種類
連絡先と場所
研究場所
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-
California
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Sacramento、California、アメリカ、95817
- UC Davis Center for Musculoskeletal Health
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in pseudo F-statistic
時間枠：7 days before, 7 days after and 28-35 days after Enbrel treatment
|
indicator of overall robustness of circadian rhythm
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7 days before, 7 days after and 28-35 days after Enbrel treatment
|
|
change in acrophase
時間枠：7 days before, 7 days after and 28-35 days after Enbrel treatment
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time of daily peak circadian activity
|
7 days before, 7 days after and 28-35 days after Enbrel treatment
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|
change in mesor
時間枠：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
|
|
change in amplitude
時間枠：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
|
|
change in Disease Activity Score (DAS)
時間枠：7 days before, 7 days after and 28-35 days after Enbrel treatment
|
RA disease severity
|
7 days before, 7 days after and 28-35 days after Enbrel treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in sleep efficiency as assessed by wrist actigraphy
時間枠：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)
時間枠：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)
時間枠：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
|
|
change in rheumatoid factor (RF)
時間枠：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
|
|
change in sleep duration as assessed by wrist actigraphy
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Nancy E Lane, M.D.、UC Davis Center for Musculoskeletal Health
- 主任研究者：Katie Stone, Ph.D.、California Pacific Medical Center Research Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1023265
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国で製造され、米国から輸出された製品。
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