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

NCT ID: NCT02686320

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-29

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Rheumatoid arthritis >65 years old

No interventions assigned to this group

Rheumatoid arthritis <50 years old

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yannick ALLANORE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique- Hôpitaux de Paris, Cochin Hospital

Locations

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Cochin hospital

Paris, Paris, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 24105334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22833532 (View on PubMed)

Other Identifiers

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NI-2015

Identifier Type: -

Identifier Source: org_study_id

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