Trial record 3 of 8 for:    presage

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02686320
First received: February 5, 2016
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of severe infections [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Occurrence of severe infection requiring hospitalization or varicella-zoster virus

  • Number of cancers [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Occurrence of solid cancer or hemopathy

  • Number of cardiovascular diseases [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Occurrence of myocardial infarction or stroke

  • Number of osteoporotic fractures [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease Activity Score (DAS 28) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate articular activity

  • Simple Disease Activity Index (SDAI) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate clinical articular activity of rheumatoid arthritis

  • Erythrocyte sedimentation rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate biological articular activity of rheumatoid arthritis

  • Measure of C-reactive protein (CRP) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate biological articular activity of rheumatoid arthritis

  • Number of synovitis and/or tenosynovitis at ultrasound of hands [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate articular activity of rheumatoid arthritis at ultrasound

  • Health assessment questionnaire (HAQ) score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Need of orthopaedic surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate severity of rheumatoid arthritis

  • Number of erosions at X-rays (hands and feet) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate severity of rheumatoid arthritis

  • Number of diabetes, arterial hypertension and dyslipidaemia [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to evaluate risks factor of cardiovascular disease

  • Number of cataracts [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of vaccinations [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Previous influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.


Estimated Enrollment: 400
Study Start Date: March 2016
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid arthritis >65 years old
Rheumatoid arthritis <50 years old

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02686320

Contacts
Contact: Muriel ELHAI, MD, PhD +33 1 58 41 31 72 muriel.elhai@cch.aphp.fr
Contact: Valerie FAUROUX, Master +33 1 58 41 12 13 valerie.fauroux@cch.aphp.fr

Locations
France
Cochin hospital Recruiting
Paris, France, 75014
Contact: Muriel ELHAI, MD, PhD    +33 1 58 41 31 72    muriel.elhai@cch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yannick ALLANORE, MD, PhD Assistance Publique- Hôpitaux de Paris, Cochin Hospital
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02686320     History of Changes
Other Study ID Numbers: NI-2015 
Study First Received: February 5, 2016
Last Updated: June 27, 2016
Health Authority: France: Ministry of Health
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on August 24, 2016