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Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65

Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02686320
Acronym
PRESAGE
Enrollment
176
Registered
2016-02-19
Start date
2016-03-29
Completion date
2022-05-30
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Elderly, infections, cardio-vascular disease, osteoporosis, cancer

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.

Interventions

None listed

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of severe infections5 yearsOccurrence of severe infection requiring hospitalization or varicella-zoster virus
Number of cancers5 yearsOccurrence of solid cancer or hemopathy
Number of cardiovascular diseases5 yearsOccurrence of myocardial infarction or stroke
Number of osteoporotic fractures5 years

Secondary

MeasureTime frameDescription
Number of synovitis and/or tenosynovitis at ultrasound of hands5 yearsto evaluate articular activity of rheumatoid arthritis at ultrasound
Health assessment questionnaire (HAQ) score5 years
Need of orthopaedic surgery5 yearsto evaluate severity of rheumatoid arthritis
Disease Activity Score (DAS 28)5 yearsto evaluate articular activity
Number of diabetes, arterial hypertension and dyslipidaemia5 yearsto evaluate risks factor of cardiovascular disease
Number of cataracts5 years
Number of vaccinations5 yearsPrevious influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.
Number of erosions at X-rays (hands and feet)5 yearsto evaluate severity of rheumatoid arthritis
Simple Disease Activity Index (SDAI)5 yearsto evaluate clinical articular activity of rheumatoid arthritis
Erythrocyte sedimentation rate5 yearsto evaluate biological articular activity of rheumatoid arthritis
Measure of C-reactive protein (CRP)5 yearsto evaluate biological articular activity of rheumatoid arthritis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026