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

Rheumatoid Arthritis Clinical Trial

— PRESAGE  

Official title:

Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02686320
• Other study ID #: NI-2015
• Status: Suspended
• Start date: March 29, 2016
• Est. completion date: July 3, 2023

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 400
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
France	Cochin hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Soubrier M, Tatar Z, Couderc M, Mathieu S, Dubost JJ. Rheumatoid arthritis in the elderly in the era of tight control. Drugs Aging. 2013 Nov;30(11):863-9. doi: 10.1007/s40266-013-0122-8. Review. — View Citation

Widdifield J, Bernatsky S, Paterson JM, Gunraj N, Thorne JC, Pope J, Cividino A, Bombardier C. Serious infections in a population-based cohort of 86,039 seniors with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Mar;65(3):353-61. doi: 10.1002/acr.21812. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of severe infections	Occurrence of severe infection requiring hospitalization or varicella-zoster virus	5 years
Primary	Number of cancers	Occurrence of solid cancer or hemopathy	5 years
Primary	Number of cardiovascular diseases	Occurrence of myocardial infarction or stroke	5 years
Primary	Number of osteoporotic fractures		5 years
Secondary	Disease Activity Score (DAS 28)	to evaluate articular activity	5 years
Secondary	Simple Disease Activity Index (SDAI)	to evaluate clinical articular activity of rheumatoid arthritis	5 years
Secondary	Erythrocyte sedimentation rate	to evaluate biological articular activity of rheumatoid arthritis	5 years
Secondary	Measure of C-reactive protein (CRP)	to evaluate biological articular activity of rheumatoid arthritis	5 years
Secondary	Number of synovitis and/or tenosynovitis at ultrasound of hands	to evaluate articular activity of rheumatoid arthritis at ultrasound	5 years
Secondary	Health assessment questionnaire (HAQ) score		5 years
Secondary	Need of orthopaedic surgery	to evaluate severity of rheumatoid arthritis	5 years
Secondary	Number of erosions at X-rays (hands and feet)	to evaluate severity of rheumatoid arthritis	5 years
Secondary	Number of diabetes, arterial hypertension and dyslipidaemia	to evaluate risks factor of cardiovascular disease	5 years
Secondary	Number of cataracts		5 years
Secondary	Number of vaccinations	Previous influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.	5 years