Clinical trial NCT02686320: Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65
Official title: Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Elderly
infections
cardio-vascular disease
osteoporosis
cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients from department A and B of rheumatology in Cochin hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of severe infections
timeFrame: 5 years
measure: Number of cancers
timeFrame: 5 years
measure: Number of cardiovascular diseases
timeFrame: 5 years
measure: Number of osteoporotic fractures
timeFrame: 5 years
Secondary outcomes:
measure: Disease Activity Score (DAS 28)
timeFrame: 5 years
measure: Simple Disease Activity Index (SDAI)
timeFrame: 5 years
measure: Erythrocyte sedimentation rate
timeFrame: 5 years
measure: Measure of C-reactive protein (CRP)
timeFrame: 5 years
measure: Number of synovitis and/or tenosynovitis at ultrasound of hands
timeFrame: 5 years
measure: Health assessment questionnaire (HAQ) score
timeFrame: 5 years
measure: Need of orthopaedic surgery
timeFrame: 5 years
measure: Number of erosions at X-rays (hands and feet)
timeFrame: 5 years
measure: Number of diabetes, arterial hypertension and dyslipidaemia
timeFrame: 5 years
measure: Number of cataracts
timeFrame: 5 years
measure: Number of vaccinations
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin hospital
Study officials:
affiliation: Assistance Publique- Hôpitaux de Paris, Cochin Hospital
name: Yannick ALLANORE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.