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
연구 개요
상세 설명
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.
연구 유형
연락처 및 위치
연구 장소
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California
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Sacramento, California, 미국, 95817
- UC Davis Center for Musculoskeletal Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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change in pseudo F-statistic
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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change in sleep efficiency as assessed by wrist actigraphy
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Nancy E Lane, M.D., UC Davis Center for Musculoskeletal Health
- 수석 연구원: Katie Stone, Ph.D., California Pacific Medical Center Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1023265
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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류마티스 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
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