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

Suspended

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02686320
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-15
• Study First Posted: 2016-02-19
• Study Start: 2016-03-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27
• Primary Completion: 2023-07-03
• Study Completion: 2023-07-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of severe infections	5 years	Occurrence of severe infection requiring hospitalization or varicella-zoster virus
Number of cancers	5 years	Occurrence of solid cancer or hemopathy
Number of cardiovascular diseases	5 years	Occurrence of myocardial infarction or stroke
Number of osteoporotic fractures	5 years

Secondary Outcome Measures

Name	Time	Method
Number of synovitis and/or tenosynovitis at ultrasound of hands	5 years	to evaluate articular activity of rheumatoid arthritis at ultrasound
Simple Disease Activity Index (SDAI)	5 years	to evaluate clinical articular activity of rheumatoid arthritis
Measure of C-reactive protein (CRP)	5 years	to evaluate biological articular activity of rheumatoid arthritis
Disease Activity Score (DAS 28)	5 years	to evaluate articular activity
Erythrocyte sedimentation rate	5 years	to evaluate biological articular activity of rheumatoid arthritis
Health assessment questionnaire (HAQ) score	5 years
Need of orthopaedic surgery	5 years	to evaluate severity of rheumatoid arthritis
Number of erosions at X-rays (hands and feet)	5 years	to evaluate severity of rheumatoid arthritis
Number of cataracts	5 years
Number of diabetes, arterial hypertension and dyslipidaemia	5 years	to evaluate risks factor of cardiovascular disease
Number of vaccinations	5 years	Previous influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.

Trial Locations

Locations (1)

Cochin hospital; 🇫🇷 Paris, France