Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65 (PRESAGE)

A

Assistance Publique - Hôpitaux de Paris

Status

Suspended

Conditions

Rheumatoid Arthritis

Study type

Observational

Funder types

Other

Identifiers

NCT02686320
NI-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Rheumatoid arthritis >65 years old
Rheumatoid arthritis <50 years old

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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