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

NCT02686320 | Terminated

• 1 other identifier: NI-2015
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Elderly; infections; cardio-vascular disease; osteoporosis; cancer

Outcome Measures

Primary Outcomes (4)

• Number of severe infections

  Occurrence of severe infection requiring hospitalization or varicella-zoster virus

  5 years

• Number of cancers

  Occurrence of solid cancer or hemopathy

  5 years

• Number of cardiovascular diseases

  Occurrence of myocardial infarction or stroke

  5 years

• Number of osteoporotic fractures

  5 years

Secondary Outcomes (11)

• Disease Activity Score (DAS 28)

  5 years

• Simple Disease Activity Index (SDAI)

  5 years

• Erythrocyte sedimentation rate

  5 years

• Measure of C-reactive protein (CRP)

  5 years

• Number of synovitis and/or tenosynovitis at ultrasound of hands

  5 years

Study Arms (2)

Rheumatoid arthritis >65 years old

Rheumatoid arthritis <50 years old

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Patients who do not understand rules and implications of the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin hospital

Paris, Paris, 75014, France

Location

Related 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.

  PMID: 24105334 BACKGROUND

• 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.

  PMID: 22833532 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Infections; Osteoporosis; Neoplasms

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yannick ALLANORE, MD, PhD

  Assistance Publique- Hôpitaux de Paris, Cochin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 19, 2016
• Study Start: March 29, 2016
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)