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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02686320
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease
Rheumatoid Arthritis

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old
Actual Study Start Date : March 29, 2016
Estimated Primary Completion Date : July 3, 2023
Estimated Study Completion Date : July 3, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of severe infections [ Time Frame: 5 years ]
    Occurrence of severe infection requiring hospitalization or varicella-zoster virus

  2. Number of cancers [ Time Frame: 5 years ]
    Occurrence of solid cancer or hemopathy

  3. Number of cardiovascular diseases [ Time Frame: 5 years ]
    Occurrence of myocardial infarction or stroke

  4. Number of osteoporotic fractures [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease Activity Score (DAS 28) [ Time Frame: 5 years ]
    to evaluate articular activity

  2. Simple Disease Activity Index (SDAI) [ Time Frame: 5 years ]
    to evaluate clinical articular activity of rheumatoid arthritis

  3. Erythrocyte sedimentation rate [ Time Frame: 5 years ]
    to evaluate biological articular activity of rheumatoid arthritis

  4. Measure of C-reactive protein (CRP) [ Time Frame: 5 years ]
    to evaluate biological articular activity of rheumatoid arthritis

  5. Number of synovitis and/or tenosynovitis at ultrasound of hands [ Time Frame: 5 years ]
    to evaluate articular activity of rheumatoid arthritis at ultrasound

  6. Health assessment questionnaire (HAQ) score [ Time Frame: 5 years ]
  7. Need of orthopaedic surgery [ Time Frame: 5 years ]
    to evaluate severity of rheumatoid arthritis

  8. Number of erosions at X-rays (hands and feet) [ Time Frame: 5 years ]
    to evaluate severity of rheumatoid arthritis

  9. Number of diabetes, arterial hypertension and dyslipidaemia [ Time Frame: 5 years ]
    to evaluate risks factor of cardiovascular disease

  10. Number of cataracts [ Time Frame: 5 years ]
  11. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid arthritis patients from department A and B of rheumatology in Cochin hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686320


Locations
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France
Cochin hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yannick ALLANORE, MD, PhD Assistance Publique- Hôpitaux de Paris, Cochin Hospital

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02686320     History of Changes
Other Study ID Numbers: NI-2015
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rheumatoid arthritis
Elderly
infections
cardio-vascular disease
osteoporosis
cancer

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases