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

September 26, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old

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.

Study Overview

Status

Suspended

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rheumatoid arthritis patients from department A and B of rheumatology in Cochin hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Rheumatoid arthritis >65 years old
Rheumatoid arthritis <50 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of severe infections
Time Frame: 5 years
Occurrence of severe infection requiring hospitalization or varicella-zoster virus
5 years
Number of cancers
Time Frame: 5 years
Occurrence of solid cancer or hemopathy
5 years
Number of cardiovascular diseases
Time Frame: 5 years
Occurrence of myocardial infarction or stroke
5 years
Number of osteoporotic fractures
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Yannick ALLANORE, MD, PhD, Assistance Publique- Hôpitaux de Paris, Cochin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2016

Primary Completion (Anticipated)

July 3, 2023

Study Completion (Anticipated)

July 3, 2023

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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