Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65 (PRESAGE)
|ClinicalTrials.gov Identifier: NCT02686320|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : March 15, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old|
|Actual Study Start Date :||March 29, 2016|
|Estimated Primary Completion Date :||July 3, 2023|
|Estimated Study Completion Date :||July 3, 2023|
|Rheumatoid arthritis >65 years old|
|Rheumatoid arthritis <50 years old|
- Number of severe infections [ Time Frame: 5 years ]Occurrence of severe infection requiring hospitalization or varicella-zoster virus
- 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 osteoporotic fractures [ Time Frame: 5 years ]
- Disease Activity Score (DAS 28) [ Time Frame: 5 years ]to evaluate articular activity
- Simple Disease Activity Index (SDAI) [ Time Frame: 5 years ]to evaluate clinical articular activity of rheumatoid arthritis
- Erythrocyte sedimentation rate [ Time Frame: 5 years ]to evaluate biological articular activity of rheumatoid arthritis
- Measure of C-reactive protein (CRP) [ Time Frame: 5 years ]to evaluate biological articular activity of rheumatoid arthritis
- Number of synovitis and/or tenosynovitis at ultrasound of hands [ Time Frame: 5 years ]to evaluate articular activity of rheumatoid arthritis at ultrasound
- Health assessment questionnaire (HAQ) score [ Time Frame: 5 years ]
- Need of orthopaedic surgery [ Time Frame: 5 years ]to evaluate severity of rheumatoid arthritis
- Number of erosions at X-rays (hands and feet) [ Time Frame: 5 years ]to evaluate severity of rheumatoid arthritis
- Number of diabetes, arterial hypertension and dyslipidaemia [ Time Frame: 5 years ]to evaluate risks factor of cardiovascular disease
- Number of cataracts [ Time Frame: 5 years ]
- Number of vaccinations [ Time Frame: 5 years ]Previous influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686320
|Paris, France, 75014|
|Principal Investigator:||Yannick ALLANORE, MD, PhD||Assistance Publique- Hôpitaux de Paris, Cochin Hospital|