Rheumatoid ArthritisPRESAGENCT02686320
Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65
An observational study of Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2016to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis patients from department A and B of rheumatology in Cochin hospital
Who may be able to join
- 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)
Who cannot join
- Patients who do not understand rules and implications of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Elderly, infections, cardio-vascular disease, osteoporosis, cancer
- Medical subject headings
- Arthritis, Rheumatoid, Infections, Osteoporosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis >65 years old | Not described | |
| Rheumatoid arthritis <50 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe infections
Occurrence of severe infection requiring hospitalization or varicella-zoster virus
Measured: 5 years
Number of cancers
Occurrence of solid cancer or hemopathy
Measured: 5 years
Number of cardiovascular diseases
Occurrence of myocardial infarction or stroke
Measured: 5 years
Number of osteoporotic fractures
Measured: 5 years
Secondary outcomes (11)
Disease Activity Score (DAS 28)
to evaluate articular activity
Measured: 5 years
Simple Disease Activity Index (SDAI)
to evaluate clinical articular activity of rheumatoid arthritis
Measured: 5 years
Erythrocyte sedimentation rate
to evaluate biological articular activity of rheumatoid arthritis
Measured: 5 years
Measure of C-reactive protein (CRP)
to evaluate biological articular activity of rheumatoid arthritis
Measured: 5 years
Number of synovitis and/or tenosynovitis at ultrasound of hands
to evaluate articular activity of rheumatoid arthritis at ultrasound
Measured: 5 years
Health assessment questionnaire (HAQ) score
Measured: 5 years
Need of orthopaedic surgery
to evaluate severity of rheumatoid arthritis
Measured: 5 years
Number of erosions at X-rays (hands and feet)
to evaluate severity of rheumatoid arthritis
Measured: 5 years
Number of diabetes, arterial hypertension and dyslipidaemia
to evaluate risks factor of cardiovascular disease
Measured: 5 years
Number of cataracts
Measured: 5 years
Number of vaccinations
Previous influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start29 Mar 2016
- Primary completion30 May 2022
- Study completion30 May 2022
Why it stopped: Study suspended due to lack of PI to handle it
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yannick ALLANORE, MD, PhD, Principal investigator, Assistance Publique- Hôpitaux de Paris, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686320
- Sponsor's protocol ID
- NI-2015
- Acronym
- PRESAGE
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24105334Widdifield 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.
PubMed 22833532
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old
- ClinicalTrials.gov ID
- NCT02686320
- Acronym / sponsor ID
- PRESAGE / NI-2015
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Elderly, infections, cardio-vascular disease, osteoporosis, cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study suspended due to lack of PI to handle it
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis >65 years old | – | – |
| Rheumatoid arthritis <50 years old | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients from department A and B of rheumatology in Cochin hospital
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients who do not understand rules and implications of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Disease Activity Score (DAS 28)
Time frame: 5 years
Simple Disease Activity Index (SDAI)
Time frame: 5 years
Erythrocyte sedimentation rate
Time frame: 5 years
Measure of C-reactive protein (CRP)
Time frame: 5 years
Number of synovitis and/or tenosynovitis at ultrasound of hands
Time frame: 5 years
Health assessment questionnaire (HAQ) score
Time frame: 5 years
Need of orthopaedic surgery
Time frame: 5 years
Number of erosions at X-rays (hands and feet)
Time frame: 5 years
Number of diabetes, arterial hypertension and dyslipidaemia
Time frame: 5 years
Number of cataracts
Time frame: 5 years
Number of vaccinations
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Study suspended due to lack of PI to handle it). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 24105334Soubrier 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.
- Background: PubMed 22833532Widdifield 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick ALLANORE, MD, PhD principal investigator
Assistance Publique- Hôpitaux de Paris, Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study suspended due to lack of PI to handle it). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of severe infections (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.