NCT05463666Active, not recruiting
STudying Ageing in Rheumatic Diseases (STAR)
Effect of Ageing on Interpretation of Disease Activity Measures and on Cognition, Physical Activity and Performance in Patients With Rheumatic Disorders
Source: ClinicalTrials.gov · Last updated 1 Oct 2025
Brief summary (registry, in English)
The primary objective of the STAR study is to investigate how measures of disease activity and measures for cognition, physical activity and performance behave in ageing population controls and patients with rheumatoid arthritis (RA). If an differential effect of age on outcome over time is apparent, the presence of an inclination point will be assessed. The secondary objective is to investigate additional factors (e.g. lifestyle factors) that might explain any differences between ageing controls and RA patients. The STAR study is an observational cross-sectional matched case-control study including 420 RA patients and 420 population controls between 55-85 years of age, stratified by five year intervals. All participants will complete generic and RA-specific questionnaires. A subset of 180 participants will be visiting the research center for physical examination and performance tests. Expected outcomes include practical age-specific reference curves that will be constructed for a selection of outcomes (e.g. DAS28). It is expected that as RA is characterized by tender and painful joints, e.g. the number of tender joints has a higher starting point in RA patients than in the general population. This will most likely increase in both groups with age, although the general population may catch up at an older age. Measures of cognitive status may show a steeper decline with age in RA patients compared to the general population. Measures of physical activity and performance will presumably have a worse starting point in RA patients than in the general population, and might show a steep decline with age. The general population might however catch up with the patients with RA. Most probably, age will not be the only factor explaining 'worse' outcomes in both RA patients and the general population. Other factors such as lifestyle factors (e.g. smoking, diet, BMI, occupation) and comorbidities will probably play a role.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 840 (estimated)
- First submitted
- 1 Jul 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 22 Apr 2025
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05463666
What you commit to
- Study type: Observational
- Planned participants: 840
- From 1 Dec 2022 to the primary completion date, 22 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A diagnosis of dementia or mental incompetency is always reason for exclusion.
Other
- Subject is the spouse/partner of the included RA patient.
- Have severe comorbidity and the treating rheumatologist and/or research team decides they should not be included in the study because of health reasons.
- Persons of whom the research team estimates that his/her life expectancy is less than 2 years.
- Do not understand the Dutch language and/or are notable to understand the study information.
Who the study is looking for
- Age between 55-85 years at baseline.
- Diagnosis of RA by treating rheumatologist.
- Age between 55-85 years at baseline.
- No diagnosis of RA, or other inflammatory RMD (osteoarthritis allowed).
Age in the registry: 55 years to 85 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.