Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Number of cancers
- Status
- Terminated
- Last Updated
- 5 months ago
Overview
Brief Summary
Rheumatoid arthritis (RA) is associated with a higher prevalence of infections, malignancies, osteoporotic fractures and cardiovascular diseases. Few data are available regarding the prevalence and severity of these comorbidities in elderly RA patients. The purpose of this study is to determine the effect of age on prevalence and severity of comorbidities in RA.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of cancers
Time Frame: 5 years
Occurrence of solid cancer or hemopathy
Number of cardiovascular diseases
Time Frame: 5 years
Occurrence of myocardial infarction or stroke
Number of severe infections
Time Frame: 5 years
Occurrence of severe infection requiring hospitalization or varicella-zoster virus
Number of osteoporotic fractures
Time Frame: 5 years
Secondary Outcomes
- Number of synovitis and/or tenosynovitis at ultrasound of hands(5 years)
- Simple Disease Activity Index (SDAI)(5 years)
- Measure of C-reactive protein (CRP)(5 years)
- Disease Activity Score (DAS 28)(5 years)
- Erythrocyte sedimentation rate(5 years)
- Health assessment questionnaire (HAQ) score(5 years)
- Need of orthopaedic surgery(5 years)
- Number of erosions at X-rays (hands and feet)(5 years)
- Number of cataracts(5 years)
- Number of diabetes, arterial hypertension and dyslipidaemia(5 years)
- Number of vaccinations(5 years)