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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

Tracking Information
First Submitted Date February 5, 2016
First Posted Date February 19, 2016
Last Update Posted Date March 15, 2019
Actual Study Start Date March 29, 2016
Estimated Primary Completion Date July 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2016)
  • Number of severe infections [ Time Frame: 5 years ]
    Occurrence of severe infection requiring hospitalization or varicella-zoster virus
  • Number of cancers [ Time Frame: 5 years ]
    Occurrence of solid cancer or hemopathy
  • Number of cardiovascular diseases [ Time Frame: 5 years ]
    Occurrence of myocardial infarction or stroke
  • Number of osteoporotic fractures [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02686320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 15, 2016)
  • Disease Activity Score (DAS 28) [ Time Frame: 5 years ]
    to evaluate articular activity
  • Simple Disease Activity Index (SDAI) [ Time Frame: 5 years ]
    to evaluate clinical articular activity of rheumatoid arthritis
  • Erythrocyte sedimentation rate [ Time Frame: 5 years ]
    to evaluate biological articular activity of rheumatoid arthritis
  • Measure of C-reactive protein (CRP) [ Time Frame: 5 years ]
    to evaluate biological articular activity of rheumatoid arthritis
  • Number of synovitis and/or tenosynovitis at ultrasound of hands [ Time Frame: 5 years ]
    to evaluate articular activity of rheumatoid arthritis at ultrasound
  • Health assessment questionnaire (HAQ) score [ Time Frame: 5 years ]
  • Need of orthopaedic surgery [ Time Frame: 5 years ]
    to evaluate severity of rheumatoid arthritis
  • Number of erosions at X-rays (hands and feet) [ Time Frame: 5 years ]
    to evaluate severity of rheumatoid arthritis
  • Number of diabetes, arterial hypertension and dyslipidaemia [ Time Frame: 5 years ]
    to evaluate risks factor of cardiovascular disease
  • Number of cataracts [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Rheumatoid arthritis patients from department A and B of rheumatology in Cochin hospital
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts
  • Rheumatoid arthritis >65 years old
  • Rheumatoid arthritis <50 years old
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 15, 2016)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 3, 2023
Estimated Primary Completion Date July 3, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02686320
Other Study ID Numbers NI-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Yannick ALLANORE, MD, PhD Assistance Publique- Hôpitaux de Paris, Cochin Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2019