Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65 (PRESAGE)
Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old
연구 개요
상태
정황
상세 설명
Prevalence of rheumatoid arthritis (RA) in elderly is increasing because of the increasing life expectancy. RA is associated with a higher prevalence of infections, malignancies, osteoporotic fractures and cardiovascular diseases. The purpose of this study is to determine the effect of age on prevalence and severity of comorbidities in RA. This study also aims to determine whether age influences disease progression and efficacy and tolerance of treatments.
This study will compare two groups of patients : patients older than 65 years old and patients younger than 50 years old, matched for gender and disease duration.
The first part of the study will be cross-sectional and will aim to compare characteristics regarding RA manifestations and comorbidities of the two groups at inclusion.
Whereas the second part will be prospective to assess the occurrence of comorbidities and the efficacy and safety of treatments in these two groups. Patients will be assessed every year during 5 years in accordance with usual follow-up of the patients.
This study could help to better manage elderly RA patients and to modify clinical practice.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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-
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Paris, 프랑스, 75014
- Cochin Hospital
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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:
- Clinical diagnosis of Rheumatoid arthritis according to American College of Rheumatology (ACR) /Eular 2010 criteria or American College of Rheumatalogy 1987 criteria
- Age >65 years or patients between 18 and 50 years matched for sex and disease duration with the group of elderly patients (control group)
Exclusion Criteria:
- Patients who do not understand rules and implications of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
|---|
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Rheumatoid arthritis >65 years old
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Rheumatoid arthritis <50 years old
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of severe infections
기간: 5 years
|
Occurrence of severe infection requiring hospitalization or varicella-zoster virus
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5 years
|
|
Number of cancers
기간: 5 years
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Occurrence of solid cancer or hemopathy
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5 years
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|
Number of cardiovascular diseases
기간: 5 years
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Occurrence of myocardial infarction or stroke
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5 years
|
|
Number of osteoporotic fractures
기간: 5 years
|
5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Disease Activity Score (DAS 28)
기간: 5 years
|
to evaluate articular activity
|
5 years
|
|
Simple Disease Activity Index (SDAI)
기간: 5 years
|
to evaluate clinical articular activity of rheumatoid arthritis
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5 years
|
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Erythrocyte sedimentation rate
기간: 5 years
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to evaluate biological articular activity of rheumatoid arthritis
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5 years
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Measure of C-reactive protein (CRP)
기간: 5 years
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to evaluate biological articular activity of rheumatoid arthritis
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5 years
|
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Number of synovitis and/or tenosynovitis at ultrasound of hands
기간: 5 years
|
to evaluate articular activity of rheumatoid arthritis at ultrasound
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5 years
|
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Health assessment questionnaire (HAQ) score
기간: 5 years
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5 years
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Need of orthopaedic surgery
기간: 5 years
|
to evaluate severity of rheumatoid arthritis
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5 years
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Number of erosions at X-rays (hands and feet)
기간: 5 years
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to evaluate severity of rheumatoid arthritis
|
5 years
|
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Number of diabetes, arterial hypertension and dyslipidaemia
기간: 5 years
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to evaluate risks factor of cardiovascular disease
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5 years
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Number of cataracts
기간: 5 years
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5 years
|
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Number of vaccinations
기간: 5 years
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Previous influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yannick ALLANORE, MD, PhD, Assistance Publique- Hôpitaux de Paris, Cochin Hospital
간행물 및 유용한 링크
일반 간행물
- Soubrier M, Tatar Z, Couderc M, Mathieu S, Dubost JJ. Rheumatoid arthritis in the elderly in the era of tight control. Drugs Aging. 2013 Nov;30(11):863-9. doi: 10.1007/s40266-013-0122-8.
- Widdifield J, Bernatsky S, Paterson JM, Gunraj N, Thorne JC, Pope J, Cividino A, Bombardier C. Serious infections in a population-based cohort of 86,039 seniors with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Mar;65(3):353-61. doi: 10.1002/acr.21812.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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